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/></a></div><div class="bkr_bib"><h1 id="_NBK578070_"><span itemprop="name">Management of abnormal muscle tone: pharmacological treatments for spasticity</span></h1><div class="subtitle">Cerebral palsy in adults</div><p><b>Evidence review A1</b></p><p><i>NICE Guideline, No. 119</i></p><p class="contrib-group"><h4>Authors</h4><span itemprop="author">National Guideline Alliance (UK)</span>.</p><div class="half_rhythm">London: <a href="https://www.nice.org.uk" ref="pagearea=meta&targetsite=external&targetcat=link&targettype=publisher"><span itemprop="publisher">National Institute for Health and Care Excellence (NICE)</span></a>; <span itemprop="datePublished">2019 Jan</span>.<div class="small">ISBN-13: <span itemprop="isbn">978-1-4731-3223-8</span></div></div><div><a href="/books/about/copyright/">Copyright</a> © NICE 2019.</div></div><div class="bkr_clear"></div></div><div id="cha1.s1"><h2 id="_cha1_s1_">Management of abnormal muscle tone in adults aged 19 and over with cerebral palsy, including spasticity and associated movement disorders such as dystonia</h2><div id="cha1.s1.1"><h3>Review question</h3><p>A1 Which pharmacological treatments for spasticity (for example, enteral baclofen, tizanidine, diazepam, cannabinoids, and botulinum toxin injections) are most effective for improving motor function, participation and quality of life in adults with cerebral palsy?</p><div id="cha1.s1.1.1"><h4>Introduction</h4><p>Spasticity is a dynamic increase in the tone of muscles, causing muscles to spasm, or to be tight, and is experienced by some adults with cerebral palsy. Spasticity can limit a person’s movement, function and quality of life. When factors that aggravate spasticity have been removed, enteral or intramuscular agents are available to treat the remaining spasticity. The aim of this review is to evaluate the effectiveness of pharmacological treatments for spasticity.</p></div><div id="cha1.s1.1.2"><h4>PICO table</h4><p>Please see <a class="figpopup" href="/books/NBK578070/table/cha1.tab1/?report=objectonly" target="object" rid-figpopup="figcha1tab1" rid-ob="figobcha1tab1">Table 1</a> for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figcha1tab1"><a href="/books/NBK578070/table/cha1.tab1/?report=objectonly" target="object" title="Table 1" class="img_link icnblk_img figpopup" rid-figpopup="figcha1tab1" rid-ob="figobcha1tab1"><img class="small-thumb" src="/books/NBK578070/table/cha1.tab1/?report=thumb" src-large="/books/NBK578070/table/cha1.tab1/?report=previmg" alt="Table 1. Summary of the protocol (PICO table)." /></a><div class="icnblk_cntnt"><h4 id="cha1.tab1"><a href="/books/NBK578070/table/cha1.tab1/?report=objectonly" target="object" rid-ob="figobcha1tab1">Table 1</a></h4><p class="float-caption no_bottom_margin">Summary of the protocol (PICO table). </p></div></div><p>For full details see the review protocol in <a href="#cha1.appa">appendix A</a></p></div><div id="cha1.s1.1.3"><h4>Methods and process</h4><p>This evidence review was developed using the methods and process described in <a href="https://www.nice.org.uk/process/pmg20/chapter/introduction-and-overview" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual 2014</a>. Methods specific to this review question are described in the review protocol in <a href="#cha1.appa">appendix A</a> and for a full description of the methods see <a href="/books/n/niceng119erbm3/?report=reader" class="toc-item">supplementary document C</a>.</p><p>Declaration of interests were recorded according to NICE’s 2014 conflicts of interest policy from May 2016 until April 2018. From April 2018 onwards they were recorded according to NICE’s 2018 <a href="https://www.nice.org.uk/About/Who-we-are/policies-and-procedures" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">conflicts of interest policy</a>. Those interests declared until April 2018 were reclassified according to NICE’s 2018 conflicts of interest policy (see Interests Register).</p></div><div id="cha1.s1.1.4"><h4>Clinical evidence</h4><div id="cha1.s1.1.4.1"><h5>Included studies</h5><p>Three studies (N=139) were included in this systematic review (<a class="bibr" href="#cha1.s1.ref1" rid="cha1.s1.ref1">Griffiths 1964</a>, <a class="bibr" href="#cha1.s1.ref2" rid="cha1.s1.ref2">Maanum 2011</a> and <a class="bibr" href="#cha1.s1.ref3" rid="cha1.s1.ref3">Marchiori 2014</a>).</p><p><a class="bibr" href="#cha1.s1.ref1" rid="cha1.s1.ref1">Griffiths 1964</a> was a randomised, double-blind crossover study evaluating the spasmolytic effect of oral diazepam compared to placebo in people with severe forms of cerebral palsy.</p><p>The other 2 studies examined the effectiveness of botulinum toxin compared to placebo or standard care. <a class="bibr" href="#cha1.s1.ref2" rid="cha1.s1.ref2">Maanum 2011</a> was a single centre, double-blind, placebo controlled randomised clinical trial assessing the short term effects of botulinum toxin A in ambulant adults with cerebral palsy and spasticity.</p><p><i><a class="bibr" href="#cha1.s1.ref3" rid="cha1.s1.ref3">Marchiori 2014</a> was a before-and-after study evaluating the effects of a single multi-site botulinum toxin injection botulinum toxin injection on spatiotemporal and kinematic parameters of adults with cerebral palsy. In addition, palsy. In addition, this study evaluated if the Gait Deviation Index (GDI) can be used to detect global changes in global changes in gait following the administration of botulinum toxin. The clinical studies included in this evidence included in this evidence review are summarised in <a class="figpopup" href="/books/NBK578070/table/cha1.tab2/?report=objectonly" target="object" rid-figpopup="figcha1tab2" rid-ob="figobcha1tab2">Table 2</a> and evidence from these is summarised in the clinical summarised in the clinical evidence profiles below (<a class="figpopup" href="/books/NBK578070/table/cha1.tab3/?report=objectonly" target="object" rid-figpopup="figcha1tab3" rid-ob="figobcha1tab3">Table 3</a> and</i>
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<a class="figpopup" href="/books/NBK578070/table/cha1.tab4/?report=objectonly" target="object" rid-figpopup="figcha1tab4" rid-ob="figobcha1tab4">Table 4</a>).</p><p>See also the literature search strategy in <a href="#cha1.appb">appendix B</a>, study selection flow chart in <a href="#cha1.appc">appendix C</a>, forest plots in <a href="#cha1.appe">appendix E</a> and study evidence tables in <a href="#cha1.appd">appendix D</a>.</p></div><div id="cha1.s1.1.4.2"><h5>Excluded studies</h5><p>Studies excluded from this systematic review, with reasons for their exclusion, are provided in <a href="#cha1.appk">appendix K</a>.</p></div></div><div id="cha1.s1.1.5"><h4>Summary of clinical studies included in the evidence review</h4><p><a class="figpopup" href="/books/NBK578070/table/cha1.tab2/?report=objectonly" target="object" rid-figpopup="figcha1tab2" rid-ob="figobcha1tab2">Table 2</a> provides a brief summary of the included studies.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figcha1tab2"><a href="/books/NBK578070/table/cha1.tab2/?report=objectonly" target="object" title="Table 2" class="img_link icnblk_img figpopup" rid-figpopup="figcha1tab2" rid-ob="figobcha1tab2"><img class="small-thumb" src="/books/NBK578070/table/cha1.tab2/?report=thumb" src-large="/books/NBK578070/table/cha1.tab2/?report=previmg" alt="Table 2. Summary of included studies." /></a><div class="icnblk_cntnt"><h4 id="cha1.tab2"><a href="/books/NBK578070/table/cha1.tab2/?report=objectonly" target="object" rid-ob="figobcha1tab2">Table 2</a></h4><p class="float-caption no_bottom_margin">Summary of included studies. </p></div></div><p>See <a href="#cha1.appd">appendix D</a> for the full evidence tables.</p></div><div id="cha1.s1.1.6"><h4>Quality assessment of clinical outcomes included in the evidence review</h4><p>The clinical evidence profiles for this review question are presented in <a class="figpopup" href="/books/NBK578070/table/cha1.tab3/?report=objectonly" target="object" rid-figpopup="figcha1tab3" rid-ob="figobcha1tab3">Table 3</a> and <a class="figpopup" href="/books/NBK578070/table/cha1.tab4/?report=objectonly" target="object" rid-figpopup="figcha1tab4" rid-ob="figobcha1tab4">Table 4</a>.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figcha1tab3"><a href="/books/NBK578070/table/cha1.tab3/?report=objectonly" target="object" title="Table 3" class="img_link icnblk_img figpopup" rid-figpopup="figcha1tab3" rid-ob="figobcha1tab3"><img class="small-thumb" src="/books/NBK578070/table/cha1.tab3/?report=thumb" src-large="/books/NBK578070/table/cha1.tab3/?report=previmg" alt="Table 3. Summary clinical evidence profile: Comparison 1: Botulinum toxin A versus no treatment or placebo." /></a><div class="icnblk_cntnt"><h4 id="cha1.tab3"><a href="/books/NBK578070/table/cha1.tab3/?report=objectonly" target="object" rid-ob="figobcha1tab3">Table 3</a></h4><p class="float-caption no_bottom_margin">Summary clinical evidence profile: Comparison 1: Botulinum toxin A versus no treatment or placebo. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figcha1tab4"><a href="/books/NBK578070/table/cha1.tab4/?report=objectonly" target="object" title="Table 4" class="img_link icnblk_img figpopup" rid-figpopup="figcha1tab4" rid-ob="figobcha1tab4"><img class="small-thumb" src="/books/NBK578070/table/cha1.tab4/?report=thumb" src-large="/books/NBK578070/table/cha1.tab4/?report=previmg" alt="Table 4. Summary clinical evidence profile: Comparison 2: oral diazepam versus no treatment or placebo." /></a><div class="icnblk_cntnt"><h4 id="cha1.tab4"><a href="/books/NBK578070/table/cha1.tab4/?report=objectonly" target="object" rid-ob="figobcha1tab4">Table 4</a></h4><p class="float-caption no_bottom_margin">Summary clinical evidence profile: Comparison 2: oral diazepam versus no treatment or placebo. </p></div></div><p>See <a href="#cha1.appf">appendix F</a> for the full GRADE tables.</p></div><div id="cha1.s1.1.7"><h4>Economic evidence</h4><div id="cha1.s1.1.7.1"><h5>Included studies</h5><p>A systematic review of the economic literature was conducted but no studies were identified which were applicable to this review question.</p></div><div id="cha1.s1.1.7.2"><h5>Excluded studies</h5><p>No studies were identified which were applicable to this review question.</p></div></div><div id="cha1.s1.1.8"><h4>Summary of studies included in the economic evidence review</h4><p>No economic evaluations were included in this review.</p></div><div id="cha1.s1.1.9"><h4>Economic model</h4><p>This question was not prioritised for economic modelling although the committee considered there may be some resource impact associated with botulinum toxin injections. Therefore a cost description was undertaken to aid considerations of resource impact and cost effectiveness.</p></div><div id="cha1.s1.1.10"><h4>Resource impact</h4><p>In the absence of economic evidence for all the interventions considered in the review question unit costs were presented to the committee to aid in their consideration of resource impact and cost effectiveness.</p><p>The Committee advised that all pharmacological treatments for spasticity (oral or parenteral) should be initiated by a specialist clinic neurologist/rehabilitation medicine consultant, specialist nurse or specialist prescribing physiotherapist. According to NHS Reference Costs 2015/16 the first attendance for a pre-assessment would cost £217 (currency code WF01B, service code 400, non-admitted face-to-face attendance, first, neurology). However, GPs who have experience in managing spasticity may prescribe pharmacological treatments without an onward referral. According to the unit costs of health and social care, one attendance with a GP would cost £36 (PSSRU 2016 including indirect care staff costs and qualifications, per patient contact lasting 9.22 minutes) whilst a prescription would cost an additional £28 (PSSRU 2016). The resource and costs following an “eligible” assessment, for all pharmacological interventions for which evidence was searched, are described below.</p><div id="cha1.s1.1.10.1"><h5>Oral pharmacological treatments</h5><p>Drug acquisition costs for all pharmacological interventions for which evidence was searched, were taken from the NHS Electronic Drug Tariff July 2018 and dosages from the BNF July 2018. (Not presented) Dosages were verified with the committee to ensure they were appropriate for this patient group.</p><p>The oral treatments under consideration would not incur administration costs as they would be administered at home, without healthcare professional assistance.</p><p>Enteral baclofen, diazepam, gabapentin and pregabalin would be monitored by the patient’s GP and by the community team at routine visits. For tizanidine this would also include liver function tests because hepatic dysfunction has been reported in association with tizanidine but rarely at daily doses up to 12mg, it is recommended that liver function tests should be monitored monthly for the first four months in patients receiving doses of 12mg and higher and in patients who develop clinical symptoms suggestive of hepatic dysfunction, such as unexplained nausea, anorexia or tiredness (see <a href="http://www.mhra.gov.uk/spc-pil/?prodName=TIZANIDINE%204%20MG%20TABLETS&subsName=TIZANIDINE&pageID=SecondLevel" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Summary of Products Characteristics</a>).</p><p>Cannabinoids on the other hand, should be monitored at least every 6 months by a specialist in secondary or tertiary care, because of their expertise and selection criteria. According to NHS Reference Costs 2015/16, a follow-up visit would cost £161 (currency code WF01A, service code 400, non-admitted face-to-face attendance follow-up, neurology).</p></div><div id="cha1.s1.1.10.2"><h5>Botulinum toxin injections</h5><p>The administration of botulinum toxin involves a day-case admission performed by a neurologist, or a specially trained physiotherapist or nurse in a specialist clinic. Botulinum toxin is also commonly administered by a rehabilitation medicine specialist in an outpatient clinic. Adults with cerebral palsy are unlikely to be sedated, but ultrasound or electromyography may be used for guidance.</p><p>The appointment for the injection of botulinum toxin has a NHS reference cost assigned – Torsion dystonia and other involuntary movements drugs band 1 (code XD09Z). This reference cost (£324) will include all costs related to the procedure, the day case admission, drug costs and staff costs.</p><p>Following an injection, patients would be monitored every 3 to 4 months by the specialist clinic at a cost of £161 (NHS Reference Costs 2015/16, currency code WF01A, service code 400, non-admitted face-to-face attendance follow-up, neurology) to assess their response and need for repeat injections.</p></div></div><div id="cha1.s1.1.11"><h4>Evidence statements</h4><div id="cha1.s1.1.11.1"><h5>Comparison 1. Botulinum toxin A versus no treatment or placebo</h5><div id="cha1.s1.1.11.1.1"><h5>Critical outcomes</h5><div id="cha1.s1.1.11.1.1.1"><h5>Motor function</h5><ul id="l84"><li id="lt314" class="half_rhythm"><div>Low quality evidence from one randomised trial including 65 people showed no clinically important difference between intramuscular injections of botulinum toxin A and placebo for motor function (as measured by the 6 Minute Walk index).</div></li><li id="lt315" class="half_rhythm"><div>Low quality evidence from one randomised trial including 65 people showed no clinically important difference between intramuscular injections of botulinum toxin A and placebo for motor function (as measured by the ‘Timed Up and Go’ index).</div></li><li id="lt316" class="half_rhythm"><div>Very low quality evidence from one observational study including 23 people showed no clinically important improvement in motor function (as measured by the Gait Deviation Index) following a single multi-site botulinum toxin injection.</div></li></ul></div><div id="cha1.s1.1.11.1.1.2"><h5>Muscle tone</h5><ul id="l85"><li id="lt317" class="half_rhythm"><div>Low quality evidence from one randomised trial including 65 people showed a clinically important beneficial effect of intramuscular injections of botulinum toxin A compared with placebo for muscle tone.</div></li></ul></div><div id="cha1.s1.1.11.1.1.3"><h5>Health related quality of life</h5><ul id="l86"><li id="lt318" class="half_rhythm"><div>Low quality evidence from one randomised trial including 65 people showed no clinically important difference between intramuscular injections of botulinum toxin A and placebo for quality of life for any of the dimensions of the SF-36 survey.</div></li></ul></div><div id="cha1.s1.1.11.1.1.4"><h5>Treatment related adverse events</h5><ul id="l87"><li id="lt319" class="half_rhythm"><div>No evidence was found for this outcome.</div></li></ul></div></div><div id="cha1.s1.1.11.1.2"><h5>Important Outcomes</h5><div id="cha1.s1.1.11.1.2.1"><h5>Patient or carer reported satisfaction</h5><ul id="l88"><li id="lt320" class="half_rhythm"><div>Low quality evidence from one randomised trial including 65 people showed a clinically important beneficial effect of intramuscular injections of botulinum toxin A compared to placebo in terms of self-reported positive treatment effect.</div></li></ul></div><div id="cha1.s1.1.11.1.2.2"><h5>Participation</h5><ul id="l89"><li id="lt321" class="half_rhythm"><div>No evidence was found for this outcome.</div></li></ul></div></div></div><div id="cha1.s1.1.11.2"><h5>Comparison 2. Oral diazepam versus no treatment or placebo</h5><div id="cha1.s1.1.11.2.1"><h5>Critical Outcomes</h5><div id="cha1.s1.1.11.2.1.1"><h5>Motor function</h5><ul id="l90"><li id="lt322" class="half_rhythm"><div>No evidence was found for this outcome.</div></li></ul></div><div id="cha1.s1.1.11.2.1.2"><h5>Muscle tone</h5><ul id="l91"><li id="lt323" class="half_rhythm"><div>Very low quality evidence from one randomised study including 50 people showed no clinically important difference between oral diazepam and placebo in terms of muscle tone.</div></li></ul></div><div id="cha1.s1.1.11.2.1.3"><h5>Health related quality of life</h5><ul id="l92"><li id="lt324" class="half_rhythm"><div>No evidence was found for this outcome.</div></li></ul></div><div id="cha1.s1.1.11.2.1.4"><h5>Treatment related adverse events</h5><ul id="l93"><li id="lt325" class="half_rhythm"><div>Very low quality evidence from one randomised study including 50 people about rates of adverse events was not reported in a way that allowed a comparison between diazepam and placebo.</div></li></ul></div></div><div id="cha1.s1.1.11.2.2"><h5>Important Outcomes</h5><div id="cha1.s1.1.11.2.2.1"><h5>Patient or carer reported satisfaction</h5><ul id="l94"><li id="lt326" class="half_rhythm"><div>No evidence was found for this outcome.</div></li></ul></div><div id="cha1.s1.1.11.2.2.2"><h5>Participation</h5><ul id="l95"><li id="lt327" class="half_rhythm"><div>No evidence was found for this outcome.</div></li></ul></div></div></div></div><div id="cha1.s1.1.12"><h4>The committee’s discussion of the evidence</h4><div id="cha1.s1.1.12.1"><h5>Interpreting the evidence</h5><div id="cha1.s1.1.12.1.1"><h5>The outcomes that matter most</h5><p>Spasticity is characterised by stiffness and a wide range of involuntary muscle spasms (sustained muscle contractions or sudden movements). The committee therefore prioritised outcomes related to motor function (such as gross motor function, muscle tone) they also agreed that this would have an impact on health-related quality of life as would any treatment related adverse events. Therefore all of these outcomes were critical when comparing pharmacological treatments for spasticity. The committee agreed that treatments should be satisfactory to patients and that it may also improve participation. These were considered as important outcomes.</p></div><div id="cha1.s1.1.12.1.2"><h5>The quality of the evidence</h5><p>The quality of the evidence for this review was assessed using GRADE. The identified evidence related only to oral diazepam and botulinum toxin A injections. For the botulinum toxin compared to placebo evidence reported outcomes related to motor function, muscle tone, health related quality of life and patient satisfaction. Only patient satisfaction was improved by botulinum toxin A treatment. The quality of evidence for all outcomes was affected by imprecision around the effect sizes which was due to the low sample size. The evidence was therefore very low to low quality according to GRADE criteria. In the comparison between diazepam and placebo only two outcomes were reported (muscle tone and treatment related adverse events). However, both outcomes were poorly reported (one on a non-validated scale’ and in the other it was unclear whether there were people with more than one adverse event). It was impossible to calculate an effect size and evidence could only be reported narratively. This evidence was therefore rated as very low quality. This made interpretation of all evidence uncertain. No evidence about enteral baclofen, dantrolene, tizanidine, gabapentin/pregabalin and cannabinoid treatment was identified.</p><p>The committee noted that studies used selective populations. Committee members noted that one study comparing botulinum toxin A with placebo excluded adults with cognitive impairments whereas another study comparing oral diazepam with placebo only included adults with severe cerebral palsy. They therefore decided that it would be difficult to extrapolate findings from this evidence.</p><p>Only one study was a parallel arm randomised controlled trial. The before and after study and the cross-over trial had inherent study limitations that made the committee less confident in the findings.</p><p>Due to the low quality of the evidence, the committee based their recommendations mainly on their expertise and experience.</p></div><div id="cha1.s1.1.12.1.3"><h5>Benefits and harms</h5><p>The committee agreed, based on their knowledge, that the risks and benefits of any treatments should be discussed with each person before treatment is initiated and specific treatment goals are agreed. In relation to potentially positive or negative effects of increased tone, the committee highlighted that goals need to be clearly set out and that this should also feature in multidisciplinary team discussions to assess potential changes in function. This would also lead to better shared decision making and would inform the assessment of whether or not treatments are effective.</p><p>Based on their experience the committee discussed that the relationship between spasticity and dystonia is not always clear to healthcare professionals and that better knowledge of this would lead to more effective shared decision. To highlight the complexity of conditions of abnormal muscle tone they therefore decided to describe that adults with cerebral palsy can have both spasticity as well as dystonia, and that symptom severity may vary.</p><p>The committee, based on their experience and expertise, agreed that there are a number of factors that can contribute to, or exacerbate, both spasticity and dystonia. They highlighted those factors that are most commonly associated with spasticity or dystonia and that are not always recognised as such. Identifying and addressing these improves the effectiveness of any multidisciplinary spasticity treatment strategy by focusing the management plan (for example if spasticity is exacerbated by pressure sores or constipation, then a treatment plan should address these factors first).</p><p>Based on their experience and expertise, the committee considered that treatment of both spasticity and dystonia can reduce pain and improve sleep, has an impact on motor function and can improve quality of life. The difference between spasticity, voluntary resistance and contractures requires careful assessment and it may not be possible to tell them apart in one assessment, or until treatment is initiated where movement is severely restricted. The committee discussed that spasticity as well as dystonia can have a positive impact on motor function. Some people with cerebral palsy make functional use of their increased muscle tone from spasticity and dystonia, for example to help them walk. For these people reduction in spasticity or dystonia could have a negative impact on certain motor functions, for example loss of their ability to transfer independently. However, severe spasticity can also have a negative impact on motor function as increased muscle tone can limit function. The committee, based on their experience, recommended a stepwise approach to interventions for spasticity, dependant on tolerability and effectiveness.</p><p>As described above this should start with non-pharmacological interventions that address the contributing or exacerbating factors and include a physical management programme (covered in evidence review document D2 on physical function).</p><p>For prescribing enteral (oral or tube) baclofen in primary/community care, the committee acknowledged that, even though no direct evidence in adults was identified, there was evidence for the effectiveness of enteral baclofen in children and young people. For example, there was evidence from randomised controlled trials in children receiving enteral baclofen which showed that there were improvements in muscle spasms (reductions in tone in lower-extremity as well as upper muscle groups - see NICE guideline <a href="https://www.nice.org.uk/guidance/cg145" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Spasticity in under 19s</a>, CG145, 2016). They were aware of potential adverse effects of oral baclofen including nausea and drowsiness, however these were usually tolerable. The committee decided that these findings could be extrapolated to adults with cerebral palsy since the pharmacokinetic and pharmacodynamic properties would be similar in adults. They therefore agreed that this would be the least invasive effective option for adults. However, since there was a lack of direct evidence, they decided to make a weak recommendation for the enteral use of this intervention.</p><p>The committee considered the weak evidence related to the use of diazepam to treat spasticity in adults with cerebral palsy. There was very low quality evidence of a number of adverse events (for instance drowsiness, vomiting and abdominal pain) that were reported by people who received diazepam. Even though they did not have much confidence in the evidence, the committee agreed that such adverse events related to diazepam were consistent with their clinical experience along with the known problems of tolerance and dependency. They therefore decided not to recommend diazepam to treat spasticity in adults with cerebral palsy. Based on their experience and expertise and evidence of some benefit in children and young people (in the <a href="https://www.nice.org.uk/guidance/cg145" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Spasticity in under 19s: management</a> NICE guideline), it was also discussed that diazepam can have a short term benefit related to the management of pain and anxiety particularly in acute situations, where the side effects on the level of consciousness and breathing can be monitored in vulnerable patients, or at the end of life. The committee agreed that the routine long-term use of diazepam in the management of spasticity should be discouraged, but that there are exceptional circumstances where it could have a short-term benefit.</p><p>The committee was aware of severe symptoms, such as life-threatening seizures, confusion and hallucinations associated with rapid withdrawal of enteral muscle relaxants and so recommended tapered withdrawal to minimise this risk. Based on their experience and knowledge the committee highlighted that this gradual withdrawal is particularly important when enteral muscle relaxants have been taken for over two months or the prescribed dosage is high.</p><p>Regarding referral to, or discussion with, a tone or spasticity management service for further pharmacological options, there was no evidence for the effectiveness and safety of other enteral pharmacological options. Therefore, the committee decided that adults with cerebral palsy and spasticity who do not tolerate enteral baclofen, or for whom it is ineffective, should be referred to a tone management service. The committee recommended that decisions about any further pharmacological treatments should only be made after referral to such specialist tone management services because of the number of treatment related adverse events.</p><p>Based on their expertise and experience, they recommended that botulinum toxin A should only be used for focal spasticity in a limited number of muscles to ensure effectiveness and minimise side effects as it is a neurotoxic substance. The committee agreed that healthcare professionals in such services can tailor, using their clinical judgement, other options (potential non-pharmacological options – see <a href="/books/n/niceng119era2/?report=reader" class="toc-item">evidence review document A2</a>) taking into account the risks and benefits in relation to the needs and goals of the individual adult with cerebral palsy and spasticity.</p><p>Due to the limited evidence, the committee made a research recommendation about how to inject botulinum toxin A. This is important because accurate placement of intramuscular botulinum toxin A is needed for efficacy and to avoid side effects. Localisation of muscles to be injected can be achieved with muscle stimulation, electromyography (EMG) signal or ultrasound to support anatomical knowledge. These techniques require equipment and training in the use of equipment and interpretation of results. Use of ultrasound may require the presence of an ultrasonographer or radiologist in addition to the clinician giving the injection. Further research could therefore provide important information on the comparative effectiveness of these techniques.</p></div><div id="cha1.s1.1.12.1.4"><h5>Cost effectiveness and resource use</h5><p>The committee noted that no relevant published economic evaluations had been identified for this topic.</p><p>The committee recognised that if spasticity is exacerbated by factors such as pain and emotional distress that are not identified and managed appropriately, they can negatively impact on participation and quality of life. Therefore, knowing what factors can exacerbate spasticity may lead to increased vigilance and thus more timely management which would be cost neutral or cost saving.</p><p>The recommendation to offer enteral baclofen as a first line option to manage spasticity should not lead to a large increase in costs as enteral baclofen is relatively cheap with a maintenance dose of 60mg a day (in divided doses) costing £0.12 (NHS Electronic Drug Tariff May 2017: 1x10mg tablet, £0.02) and is already widely used in current clinical practice as a first line option. Despite this, the committee were unable to make a stronger recommendation as there was no comparative clinical evidence that baclofen was the most effective option.</p><p>The committee referred to the evidence that diazepam provided no additional benefit compared to placebo and agreed that relatively cheap treatments should not be recommended if they are ineffective. The committee also noted that adults with cerebral palsy are frequently prescribed diazepam in primary care when alternative options should be explored. For this reason, the committee made a recommendation to not routinely prescribe diazepam to stop the use of limited resources on ineffective practices.</p><p>The committee noted that general practitioners in primary care prescribe treatments for spasticity, but agreed they should refer to, or discuss with, healthcare professionals who have experience in tonal disorders, when spasticity is causing problems with pain or impaired function, to ensure the assessment and subsequent management is appropriate for each individual. The committee agreed that the cost of specialist input would be offset by the downstream costs from potentially inappropriate management and the missed adverse effects of treatment.</p><p>The committee noted that no one should remain on cheap treatments that are ineffective, as the burden of treatment and long-term cost, including the cost to manage their potential adverse events could be substantial. However, it is important to note that muscle relaxants should be discontinued gradually, to minimise withdrawal symptoms such as anxiety and distress, as those symptoms would offset the cost of immediate discontinuation.</p><p>If baclofen is ineffective or not tolerated, the committee stated that alternative pharmacological treatments such as tizanidine, dantrolene or gabapentin would be considered for generalised spasticity. However, there was no evidence for the effectiveness of these and all of them are associated with a number of possible adverse effects. The committee recommended that decisions about any further pharmacological treatments should only be made after referral to specialist tone management services. The cost of these drugs can then be offset by the benefits of an approach tailored to the individual needs of the adult with cerebral palsy. When spasticity is focal, the committee agreed there was clinical evidence to suggest the cost of botulinum toxin could be outweighed by its benefits. Combined with the committee’s clinical experience and expertise, the committee focussed their recommendation to consider referral for botulinum toxin for focal spasticity that is causing pain, impacting care, or impairing activity, to reduce the number of inappropriate referrals.</p><p>Injecting botulinum toxin is complex and should be assessed and administered by specialists who are competent in its management, to minimise the risks the injection can entail. The committee referred to <a href="https://www.nice.org.uk/guidance/cg145" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Spasticity in under 19s: management</a> CG145 which considers the role of EMG or ultrasound to guide botulinum toxin treatment and considered these to be appropriate in an adult population as well, though they also recognised potential cost implications associated with this. Therefore the committee made a research recommendation to assess if guided botulinum toxin treatment using EMG or ultrasound is cost effective.</p></div></div></div></div><div id="rl.r1"><h3>References</h3><ul class="simple-list"><li class="half_rhythm"><p><div class="bk_ref" id="cha1.s1.ref1"><p id="p-180">
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<strong>Griffiths 1964</strong>
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</p>Griffiths
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APW, Sylvester
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PE (1964). Clinical trial of diazepam in adult cerebral palsy. Annals of physical medicine; Suppl:25–9 [<a href="https://pubmed.ncbi.nlm.nih.gov/5317890" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 5317890</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="cha1.s1.ref2"><p id="p-181">
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<strong>Maanum 2011</strong>
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</p>Maanum
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G, Jahnsen
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R, Stanghelle
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JK, et al (2011). Effects of botulinum toxin A in ambulant adults with spastic cerebral palsy: a randomized double-blind placebo controlled trial. Journal of Rehabilitation Medicine, 43:338–347 [<a href="https://pubmed.ncbi.nlm.nih.gov/21305227" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21305227</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="cha1.s1.ref3"><p id="p-182">
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<strong>Marchiori 2014</strong>
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</p>Marchiori
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C, Roche
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N, Vuillerme
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N, et al (2014). Effect of multisite botulinum toxin injections on gait quality in adults with cerebral palsy. Disability & Rehabilitation; 36:1971–4 [<a href="https://pubmed.ncbi.nlm.nih.gov/24499209" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24499209</span></a>]</div></p></li></ul></div></div><div id="appendixes.appgroupa1"><h2 id="_appendixes_appgroupa1_">Appendices</h2><div id="cha1.appa"><h3>Appendix A. Review protocols</h3><p>Review protocol for review question A1: Which pharmacological treatments for spasticity (for example, enteral baclofen, tizanidine, diazepam, cannabinoids, and botulinum toxin injections) are most effective for improving motor function, participation and quality of life in adults with cerebral palsy?</p><p id="cha1.appa.et1"><a href="/books/NBK578070/bin/cha1-appa-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 5. Review protocol for pharmacological treatments for spasticity</a><span class="small"> (PDF, 319K)</span></p></div><div id="cha1.appb"><h3>Appendix B. Literature search strategies</h3><p>Literature search strategies for review question A1: Which pharmacological treatments for spasticity (for example, enteral baclofen, tizanidine, diazepam, cannabinoids, and botulinum toxin injections) are most effective for improving motor function, participation and quality of life in adults with cerebral palsy?</p><p>This appendix is a combined search strategy and will be the same for all the evidence reviews for the A review questions as listed below:
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<ul id="l96" class="simple-list"><li id="lt328" class="half_rhythm"><div>A1: Which pharmacological treatments for spasticity (for example, enteral baclofen, tizanidine, diazepam, cannabinoids, and botulinum toxin injections) are most effective for improving motor function, participation and quality of life in adults with cerebral palsy?</div></li><li id="lt329" class="half_rhythm"><div>A2: Are neurosurgical procedures (intrathecal baclofen pump and selective dorsal rhizotomy) effective in adults aged 19 and over with cerebral palsy to reduce spasticity and or dystonia?</div></li><li id="lt330" class="half_rhythm"><div>A3: Which treatments (pharmacological treatment (levodopa, anticholinergic drugs, and botulinum toxin injections), neurosurgical procedure (deep brain stimulation, ITB)) are most effective for managing dystonia in adults with cerebral palsy where dystonia is the predominant abnormality of tone?</div></li></ul></p><div id="cha1.appb.s1"><h4>Database: Medline & Embase (Multifile)</h4><p>Database(s): Embase 1974 to 2018 March 22, Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) 1946 to Present</p><p id="cha1.appb.tab1"><a href="/books/NBK578070/table/cha1.appb.tab1/?report=objectonly" target="object" rid-ob="figobcha1appbtab1" class="figpopup">Table 6. Last searched on 22 March 2018</a></p></div><div id="cha1.appb.s2"><h4>Database: Cochrane Library</h4><p id="cha1.appb.tab2"><a href="/books/NBK578070/table/cha1.appb.tab2/?report=objectonly" target="object" rid-ob="figobcha1appbtab2" class="figpopup">Table 7. Last searched on 22 March 2018</a></p></div><div id="cha1.appb.s3"><h4>Database: Web of Science</h4><p id="cha1.appb.tab3"><a href="/books/NBK578070/table/cha1.appb.tab3/?report=objectonly" target="object" rid-ob="figobcha1appbtab3" class="figpopup">Table 8. Last searched on 27 March 2018</a></p></div></div><div id="cha1.appc"><h3>Appendix C. Clinical evidence study selection</h3><p>Clinical evidence study selection for review question A1: Which pharmacological treatments for spasticity (for example, enteral baclofen, tizanidine, diazepam, cannabinoids, and botulinum toxin injections) are most effective for improving motor function, participation and quality of life in adults with cerebral palsy?</p><p id="cha1.appc.fig1"><a href="/books/NBK578070/figure/cha1.appc.fig1/?report=objectonly" target="object" rid-ob="figobcha1appcfig1" class="figpopup">Figure 1. Flow diagram of clinical article selection for pharmacological treatments for spasticity review</a></p></div><div id="cha1.appd"><h3>Appendix D. Clinical evidence tables</h3><p>Clinical evidence tables for review question A1: Which pharmacological treatments for spasticity (for example, enteral baclofen, tizanidine, diazepam, cannabinoids, and botulinum toxin injections) are most effective for improving motor function, participation and quality of life in adults with cerebral palsy?</p><p id="cha1.appd.et1"><a href="/books/NBK578070/bin/cha1-appd-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 9. Studies included in the evidence review for pharmacological treatments for spasticity</a><span class="small"> (PDF, 294K)</span></p></div><div id="cha1.appe"><h3>Appendix E. Forest plots</h3><p>Forest plots for review question A1: Which pharmacological treatments for spasticity (for example, enteral baclofen, tizanidine, diazepam, cannabinoids, and botulinum toxin injections) are most effective for improving motor function, participation and quality of life in adults with cerebral palsy?</p><div id="cha1.appe.s1"><h4>Comparison 1. Botulinum toxin A versus no treatment or placebo</h4><p id="cha1.appe.fig1"><a href="/books/NBK578070/figure/cha1.appe.fig1/?report=objectonly" target="object" rid-ob="figobcha1appefig1" class="figpopup">Figure 2. Motor function: 6 minute Walk Test</a></p><p id="cha1.appe.fig2"><a href="/books/NBK578070/figure/cha1.appe.fig2/?report=objectonly" target="object" rid-ob="figobcha1appefig2" class="figpopup">Figure 3. Motor function: Timed Up and Go</a></p><p id="cha1.appe.fig3"><a href="/books/NBK578070/figure/cha1.appe.fig3/?report=objectonly" target="object" rid-ob="figobcha1appefig3" class="figpopup">Figure 4. Muscle tone</a></p><p id="cha1.appe.fig4"><a href="/books/NBK578070/figure/cha1.appe.fig4/?report=objectonly" target="object" rid-ob="figobcha1appefig4" class="figpopup">Figure 5. Health related quality of life (SF-36)</a></p><p id="cha1.appe.fig5"><a href="/books/NBK578070/figure/cha1.appe.fig5/?report=objectonly" target="object" rid-ob="figobcha1appefig5" class="figpopup">Figure 6. Patient reported satisfaction</a></p></div></div><div id="cha1.appf"><h3>Appendix F. GRADE tables</h3><p>GRADE tables for review question A1: Which pharmacological treatments for spasticity (for example, enteral baclofen, tizanidine, diazepam, cannabinoids, and botulinum toxin injections) are most effective for improving motor function, participation and quality of life in adults with cerebral palsy?</p><p id="cha1.appf.et1"><a href="/books/NBK578070/bin/cha1-appf-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 10. Clinical evidence profile: Comparison 1: Botulinum toxin A injection versus no treatment or placebo</a><span class="small"> (PDF, 346K)</span></p><p id="cha1.appf.et2"><a href="/books/NBK578070/bin/cha1-appf-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 11. Clinical evidence profile: Comparison 2: oral diazepam versus placebo</a><span class="small"> (PDF, 240K)</span></p></div><div id="cha1.appg"><h3>Appendix G. Economic evidence study selection</h3><p>Economic evidence study selection for review question A1: Which pharmacological treatments for spasticity (for example, enteral baclofen, tizanidine, diazepam, cannabinoids, and botulinum toxin injections) are most effective for improving motor function, participation and quality of life in adults with cerebral palsy?</p><p>No economic evidence was identified for this review.</p></div><div id="cha1.apph"><h3>Appendix H. Economic evidence tables</h3><p>Economic evidence tables for review question A1: Which pharmacological treatments for spasticity (for example, enteral baclofen, tizanidine, diazepam, cannabinoids, and botulinum toxin injections) are most effective for improving motor function, participation and quality of life in adults with cerebral palsy?</p><p>No economic evidence was identified for this review.</p></div><div id="cha1.appi"><h3>Appendix I. Health economic evidence profiles</h3><p>Health economic evidence profiles for review question A1: Which pharmacological treatments for spasticity (for example, enteral baclofen, tizanidine, diazepam, cannabinoids, and botulinum toxin injections) are most effective for improving motor function, participation and quality of life in adults with cerebral palsy?</p><p>No economic evidence was identified for this review.</p></div><div id="cha1.appj"><h3>Appendix J. Health economic analysis</h3><p>Health economic analysis for review question A1: Which pharmacological treatments for spasticity (for example, enteral baclofen, tizanidine, diazepam, cannabinoids, and botulinum toxin injections) are most effective for improving motor function, participation and quality of life in adults with cerebral palsy?</p><p>No economic analysis was included in this review.</p></div><div id="cha1.appk"><h3>Appendix K. Excluded studies</h3><p>Clinical and economic lists of excluded studies for review question A1: Which pharmacological treatments for spasticity (for example, enteral baclofen, tizanidine, diazepam, cannabinoids, and botulinum toxin injections) are most effective for improving motor function, participation and quality of life in adults with cerebral palsy?</p><div id="cha1.appk.s1"><h4>Clinical studies</h4><p id="cha1.appk.et1"><a href="/books/NBK578070/bin/cha1-appk-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 12. Excluded clinical studies for pharmacological treatments for spasticity</a><span class="small"> (PDF, 335K)</span></p></div><div id="cha1.appk.s2"><h4>Economic studies</h4><p>No economic evidence was identified for this review.</p></div></div><div id="cha1.appl"><h3>Appendix L. Research recommendations</h3><p>Research recommendations for review question A1: Which pharmacological treatments for spasticity (for example, enteral baclofen, tizanidine, diazepam, cannabinoids, and botulinum toxin injections) are most effective for improving motor function, participation and quality of life in adults with cerebral palsy?</p><p>Is guided Botulinum Toxin A injection using electrical localisation (electrical stimulation or electromyography) of muscles more effective and cost-effective than ultrasound guided or clinical positioning for localisation of injections in treating focal spasticity in adults with cerebral palsy?</p><p id="cha1.appl.tab1"><a href="/books/NBK578070/table/cha1.appl.tab1/?report=objectonly" target="object" rid-ob="figobcha1appltab1" class="figpopup">Table 13. Research recommendation rationale</a></p><p id="cha1.appl.tab2"><a href="/books/NBK578070/table/cha1.appl.tab2/?report=objectonly" target="object" rid-ob="figobcha1appltab2" class="figpopup">Table 14. Research recommendation modified PICO table</a></p></div></div></div><div class="fm-sec"><div><p>Final</p></div><div><p>Evidence reviews</p><p>These evidence reviews were developed by the National Guideline Alliance, hosted by the Royal College of Obstetricians and Gynaecologists</p></div><div><p><b>Disclaimer</b>: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.</p><p>Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.</p><p>NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the <a href="http://wales.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Welsh Government</a>, <a href="http://www.scotland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Scottish Government</a>, and <a href="http://www.northernireland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Northern Ireland Executive</a>. All NICE guidance is subject to regular review and may be updated or withdrawn.</p></div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> © NICE 2019.</div><div class="small"><span class="label">Bookshelf ID: NBK578070</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/35192276" title="PubMed record of this title" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">35192276</a></span></div></div><div class="small-screen-prev"></div><div class="small-screen-next"></div></article><article data-type="table-wrap" id="figobcha1tab1"><div id="cha1.tab1" class="table"><h3><span class="label">Table 1</span><span class="title">Summary of the protocol (PICO table)</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK578070/table/cha1.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__cha1.tab1_lrgtbl__"><table><tbody><tr><th id="hd_b_cha1.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Population</th><td headers="hd_b_cha1.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adults aged 19 years and over with cerebral palsy and spasticity (at least 50% of study population should be 18 years or older)</td></tr><tr><th id="hd_b_cha1.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention</th><td headers="hd_b_cha1.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Enteral
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<ul id="l75"><li id="lt285" class="half_rhythm"><div>Baclofen</div></li><li id="lt286" class="half_rhythm"><div>Dantrolene</div></li><li id="lt287" class="half_rhythm"><div>Tizanidine</div></li><li id="lt288" class="half_rhythm"><div>Diazepam</div></li><li id="lt289" class="half_rhythm"><div>Gabapentin/pregabalin</div></li><li id="lt290" class="half_rhythm"><div>Cannabinoids</div></li></ul>
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Botulinum toxin injections</td></tr><tr><th id="hd_b_cha1.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparison</th><td headers="hd_b_cha1.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul id="l76"><li id="lt291" class="half_rhythm"><div>Each other</div></li><li id="lt292" class="half_rhythm"><div>Placebo/no treatment</div></li></ul></td></tr><tr><th id="hd_b_cha1.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcome</th><td headers="hd_b_cha1.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Critical
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<ul id="l77"><li id="lt293" class="half_rhythm"><div>Motor function
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<ul id="l78" class="circle"><li id="lt294" class="half_rhythm"><div>Swallowing problems</div></li><li id="lt295" class="half_rhythm"><div>Goal Attainment Scale (GAS)</div></li><li id="lt296" class="half_rhythm"><div>Functional Independence Measure (FIM)</div></li></ul></div></li><li id="lt297" class="half_rhythm"><div>Muscle tone</div></li><li id="lt298" class="half_rhythm"><div>Health-related quality of life</div></li><li id="lt299" class="half_rhythm"><div>Treatment related adverse events
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<ul id="l79" class="circle"><li id="lt300" class="half_rhythm"><div>Swallowing problems</div></li><li id="lt301" class="half_rhythm"><div>Seizure threshold</div></li><li id="lt302" class="half_rhythm"><div>Undue weakness/loss of function – use of spasticity positively</div></li><li id="lt303" class="half_rhythm"><div>Drowsiness and cognitive change</div></li><li id="lt304" class="half_rhythm"><div>Specific problems in people with low proximal tone and high peripheral tone</div></li></ul></div></li></ul>
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<b>Important</b>
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<ul id="l80"><li id="lt305" class="half_rhythm"><div>Patient or carer reported satisfaction</div></li><li id="lt306" class="half_rhythm"><div>Participation</div></li></ul></td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobcha1tab2"><div id="cha1.tab2" class="table"><h3><span class="label">Table 2</span><span class="title">Summary of included studies</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK578070/table/cha1.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__cha1.tab2_lrgtbl__"><table><thead><tr><th id="hd_h_cha1.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Study</th><th id="hd_h_cha1.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Design</th><th id="hd_h_cha1.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Participants</th><th id="hd_h_cha1.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Comparisons</th><th id="hd_h_cha1.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Outcomes</th></tr></thead><tbody><tr><td headers="hd_h_cha1.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a class="bibr" href="#cha1.s1.ref1" rid="cha1.s1.ref1">Griffiths 1964</a>
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</td><td headers="hd_h_cha1.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Randomised, crossover study</td><td headers="hd_h_cha1.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>50 people with severe forms of cerebral palsy (age 12 to 73 years; mean 32 years).</p>
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<p>United Kingdom</p>
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</td><td headers="hd_h_cha1.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Oral diazepam versus placebo</td><td headers="hd_h_cha1.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul id="l81"><li id="lt307" class="half_rhythm"><div>Muscle tone</div></li><li id="lt308" class="half_rhythm"><div>Treatment related adverse effects</div></li></ul></td></tr><tr><td headers="hd_h_cha1.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a class="bibr" href="#cha1.s1.ref2" rid="cha1.s1.ref2">Maanum 2011</a>
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</td><td headers="hd_h_cha1.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Randomised controlled trial</td><td headers="hd_h_cha1.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>66 ambulant adults with cerebral palsy and spasticity (age 18 to 65 years; mean 37 years).</p>
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<p>Norway</p>
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</td><td headers="hd_h_cha1.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Botulinum toxin A injection versus placebo</td><td headers="hd_h_cha1.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul id="l82"><li id="lt309" class="half_rhythm"><div>Motor function</div></li><li id="lt310" class="half_rhythm"><div>Muscle tone</div></li><li id="lt311" class="half_rhythm"><div>Health-related quality of life</div></li><li id="lt312" class="half_rhythm"><div>Patient or carer reported satisfaction</div></li></ul></td></tr><tr><td headers="hd_h_cha1.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a class="bibr" href="#cha1.s1.ref3" rid="cha1.s1.ref3">Marchiori 2014</a>
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</td><td headers="hd_h_cha1.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Observational before-and-after study</td><td headers="hd_h_cha1.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>23 ambulant adults with cerebral palsy and spasticity (age 18 to 36 years; mean 25 years).</p>
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<p>France</p>
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</td><td headers="hd_h_cha1.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Single multi-site botulinum toxin injection versus pre-injection.</td><td headers="hd_h_cha1.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul id="l83"><li id="lt313" class="half_rhythm"><div>Motor function</div></li></ul></td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobcha1tab3"><div id="cha1.tab3" class="table"><h3><span class="label">Table 3</span><span class="title">Summary clinical evidence profile: Comparison 1: Botulinum toxin A versus no treatment or placebo</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK578070/table/cha1.tab3/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__cha1.tab3_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_cha1.tab3_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_cha1.tab3_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_cha1.tab3_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Illustrative comparative risks (95% CI)</th><th id="hd_h_cha1.tab3_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_cha1.tab3_1_1_1_3" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_cha1.tab3_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_cha1.tab3_1_1_1_4" style="text-align:left;vertical-align:bottom;">No of participant (studies)</th><th id="hd_h_cha1.tab3_1_1_1_5" rowspan="2" colspan="1" headers="hd_h_cha1.tab3_1_1_1_5" style="text-align:left;vertical-align:bottom;">Quality of the evidence (GRADE)</th></tr><tr><th headers="hd_h_cha1.tab3_1_1_1_2" id="hd_h_cha1.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Assumed risk: no treatment/placebo</th><th headers="hd_h_cha1.tab3_1_1_1_2" id="hd_h_cha1.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Corresponding risk: botulinum toxin A</th></tr></thead><tbody><tr><td headers="hd_h_cha1.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Motor function 6 Minute Walk Test</p>
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<p>Follow up: 8 weeks</p>
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</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean change from baseline in the control group was 11.0 metres higher</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The adjusted mean change from baseline in the intervention group was 7.9 metres higher (8.3 lower to 24.1 higher)</td><td headers="hd_h_cha1.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>65</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Low<sup>1</sup><sup>,</sup><sup>2</sup></td></tr><tr><td headers="hd_h_cha1.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Motor function Timed Up and Go</p>
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<p>Follow up: 8 weeks</p>
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</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean change from baseline in the control group was 0.14 min lower</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The adjusted mean change from baseline in the intervention group was 0.21 min lower (0.6 lower to 0.2 higher)</td><td headers="hd_h_cha1.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>65</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Low<sup>1</sup><sup>,</sup><sup>2</sup></td></tr><tr><td headers="hd_h_cha1.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Motor function Gait Deviation Index</p>
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<p>Follow up: 1 month</p>
|
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</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_1 hd_h_cha1.tab3_1_1_2_2 hd_h_cha1.tab3_1_1_1_3" colspan="3" rowspan="1" style="text-align:left;vertical-align:top;">The authors observed a mean reduction of 3.2 points (p = 0.02; which did not meet the MID of 4 points) between pre- and post-assessment. The 95% CI were not reported</td><td headers="hd_h_cha1.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>23</p>
|
|
<p>(1 observational study)</p>
|
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</td><td headers="hd_h_cha1.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Very low<sup>2</sup><sup>,</sup><sup>3</sup><sup>,</sup><sup>4</sup></td></tr><tr><td headers="hd_h_cha1.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>Muscle tone – Muscle stiffness/spasticity visual analogue scale.</p>
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<p>Follow up: 8 weeks</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean change from baseline in the control group was 5.1 lower</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The adjusted mean difference in the intervention group was 9.6 lower (18.7 lower to 1.2 lower)</td><td headers="hd_h_cha1.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>65</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Low<sup>1</sup><sup>,</sup><sup>2</sup></td></tr><tr><td headers="hd_h_cha1.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>Health related quality of life – Short Form 36 (SF-36) – mental health dimension</p>
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<p>Follow up: 8 weeks</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mean change from baseline in the control group was 1.6 higher</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The adjusted mean difference in the intervention group was 1.4 higher (4.4 lower to 7.2 higher)</td><td headers="hd_h_cha1.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>65</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Low<sup>1</sup><sup>,</sup><sup>2</sup></td></tr><tr><td headers="hd_h_cha1.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Health related quality of life – SF-36 – vitality dimension</p>
|
|
<p>Follow up: 8 weeks</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mean change from baseline in the control group was 5.0 higher</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The adjusted mean difference in the intervention group was 0.27 lower (7.8 lower to 7.7 higher)</td><td headers="hd_h_cha1.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>65</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Low<sup>1</sup><sup>,</sup><sup>2</sup></td></tr><tr><td headers="hd_h_cha1.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Health related quality of life – SF-36 – bodily pain dimension</p>
|
|
<p>Follow up: 8 weeks</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mean change from baseline in the control group was 8.1 higher</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The adjusted mean difference in the intervention group was 4.4 lower (12.9 lower to 4.2 higher)</td><td headers="hd_h_cha1.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>65</p>
|
|
<p>(1 study)</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Low<sup>1</sup><sup>,</sup><sup>2</sup></td></tr><tr><td headers="hd_h_cha1.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Health related quality of life – SF-36 – general health dimension</p>
|
|
<p>Follow up: 8 weeks</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mean change from baseline in the control group was 4.2 higher</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The adjusted mean difference in the intervention group was 4.7 lower (11.8 lower to 2.4 higher)</td><td headers="hd_h_cha1.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>65</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Low<sup>1</sup><sup>,</sup><sup>2</sup></td></tr><tr><td headers="hd_h_cha1.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Health related quality of life – SF-36 – social function dimension</p>
|
|
<p>Follow up: 8 weeks</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mean change from baseline in the control group was 0.8 higher</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The adjusted mean difference in the intervention group was 3.4 higher (4.0 lower to 10.9 higher)</td><td headers="hd_h_cha1.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>65</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Low<sup>1</sup><sup>,</sup><sup>2</sup></td></tr><tr><td headers="hd_h_cha1.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Health related quality of life – SF-36 – physical function dimension</p>
|
|
<p>Follow up: 8 weeks</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mean change from baseline in the control group was 3.9 higher</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The adjusted mean difference in the intervention group was 1.2 lower (7.6 lower to 5.2 higher)</td><td headers="hd_h_cha1.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>65</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Low<sup>1</sup><sup>,</sup><sup>2</sup></td></tr><tr><td headers="hd_h_cha1.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Health related quality of life – SF-36 – role physical dimension</p>
|
|
<p>Follow up: 8 weeks</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mean change from baseline in the control group was 9.1 higher</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The adjusted mean difference in the intervention group was 11.6 lower (29.1 lower to 5.9 higher)</td><td headers="hd_h_cha1.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>65</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Low<sup>1</sup><sup>,</sup><sup>2</sup></td></tr><tr><td headers="hd_h_cha1.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Health related quality of life – SF-36 – role emotional dimension</p>
|
|
<p>Follow up: 8 weeks</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mean change from baseline in the control group was 2.0 higher</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The adjusted mean difference in the intervention group was 5.7 higher (8.1 lower to 19.5 higher)</td><td headers="hd_h_cha1.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>65</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Low<sup>1</sup><sup>,</sup><sup>2</sup></td></tr><tr><td headers="hd_h_cha1.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Treatment related adverse events – Not reported</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td></tr><tr><td headers="hd_h_cha1.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Patient or carer reported satisfaction – Number of patients reporting a positive treatment effect on a three point global verbal scale</p>
|
|
<p>Follow up: 8 weeks</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">273 per 1000</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>595 per 1000</p>
|
|
<p>(316 to 1000)</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 2.18 (1.16 to 4.07)</td><td headers="hd_h_cha1.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>65</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_cha1.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Low<sup>1</sup><sup>,</sup><sup>2</sup></td></tr><tr><td headers="hd_h_cha1.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Participation – Not reported</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_2 hd_h_cha1.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">CI: confidence interval; MID, minimally important difference; RR: risk ratio; SF-36: 36 item short form survey.</p></div></dd></dl><dl class="bkr_refwrap"><dt>1</dt><dd><div id="cha1.tab3_1"><p class="no_margin">Downgraded for serious indirectness as the participants were highly functioning adults with cerebral palsy. Patients with cognitive impairment were excluded from this study</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="cha1.tab3_2"><p class="no_margin">Downgraded for serious imprecision due to sample size < 400 or number of events < 300</p></div></dd></dl><dl class="bkr_refwrap"><dt>3</dt><dd><div id="cha1.tab3_3"><p class="no_margin">Downgraded for serious risk of bias due to the risk of selective reporting identified in this study</p></div></dd></dl><dl class="bkr_refwrap"><dt>4</dt><dd><div id="cha1.tab3_4"><p class="no_margin">Downgraded for serious indirectness as the control participants in this before and after study were healthy participants</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobcha1tab4"><div id="cha1.tab4" class="table"><h3><span class="label">Table 4</span><span class="title">Summary clinical evidence profile: Comparison 2: oral diazepam versus no treatment or placebo</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK578070/table/cha1.tab4/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__cha1.tab4_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_cha1.tab4_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_cha1.tab4_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_cha1.tab4_1_1_1_2" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Illustrative comparative risks (95% CI)</th><th id="hd_h_cha1.tab4_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_cha1.tab4_1_1_1_3" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_cha1.tab4_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_cha1.tab4_1_1_1_4" style="text-align:left;vertical-align:bottom;">No of participants (studies)</th><th id="hd_h_cha1.tab4_1_1_1_5" rowspan="2" colspan="1" headers="hd_h_cha1.tab4_1_1_1_5" style="text-align:left;vertical-align:bottom;">Quality of evidence (GRADE)</th></tr><tr><th headers="hd_h_cha1.tab4_1_1_1_2" id="hd_h_cha1.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Assumed risk: no treatment/placebo</th><th headers="hd_h_cha1.tab4_1_1_1_2" id="hd_h_cha1.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Corresponding risk: diazepam</th></tr></thead><tbody><tr><td headers="hd_h_cha1.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Motor function – Not reported</td><td headers="hd_h_cha1.tab4_1_1_1_2 hd_h_cha1.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_2 hd_h_cha1.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td></tr><tr><td headers="hd_h_cha1.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Muscle tone – Number of participants identified as becoming ‘slightly better’ during a clinical assessment using a standardised form</p>
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<p>Follow up: 6 weeks</p>
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</td><td headers="hd_h_cha1.tab4_1_1_1_2 hd_h_cha1.tab4_1_1_2_1 hd_h_cha1.tab4_1_1_2_2 hd_h_cha1.tab4_1_1_1_3" colspan="3" rowspan="1" style="text-align:left;vertical-align:top;">The authors identified one participant who became slightly better after receiving diazepam, and one participant who became slightly better after receiving the control (inactive) tablet</td><td headers="hd_h_cha1.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>50</p>
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<p>(1 study)</p>
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</td><td headers="hd_h_cha1.tab4_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Very low<sup>1</sup><sup>,</sup><sup>2</sup></td></tr><tr><td headers="hd_h_cha1.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Health related quality of life – Not reported</td><td headers="hd_h_cha1.tab4_1_1_1_2 hd_h_cha1.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_2 hd_h_cha1.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td></tr><tr><td headers="hd_h_cha1.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Treatment related adverse events – Number of adverse events reported</p>
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<p>Follow up: 6 weeks</p>
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</td><td headers="hd_h_cha1.tab4_1_1_1_2 hd_h_cha1.tab4_1_1_2_1 hd_h_cha1.tab4_1_1_2_2 hd_h_cha1.tab4_1_1_1_3" colspan="3" rowspan="1" style="text-align:left;vertical-align:top;">Drowsiness was reported in 13 participants, anorexia in four, slurring of speech in two, depression in one, vomiting in four, abdominal pain in one, aggressive tendencies in two, and a faint localised rash in one. Each patient could have experienced more than one adverse event; however, this was not reported.</td><td headers="hd_h_cha1.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>50</p>
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<p>(1 study)</p>
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</td><td headers="hd_h_cha1.tab4_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Very low<sup>2</sup><sup>,</sup><sup>3</sup></td></tr><tr><td headers="hd_h_cha1.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Patient or carer reported satisfaction – Not reported</td><td headers="hd_h_cha1.tab4_1_1_1_2 hd_h_cha1.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_2 hd_h_cha1.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td></tr><tr><td headers="hd_h_cha1.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Participation – Not reported</td><td headers="hd_h_cha1.tab4_1_1_1_2 hd_h_cha1.tab4_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_2 hd_h_cha1.tab4_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_cha1.tab4_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">CI: confidence interval.</p></div></dd></dl><dl class="bkr_refwrap"><dt>1</dt><dd><div id="cha1.tab4_1"><p class="no_margin">Downgraded for serious indirectness as the participants were some of the “most severely affected” patients with cerebral palsy</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="cha1.tab4_2"><p class="no_margin">Downgraded for serious imprecision due to sample size < 400 or number of events < 300, and the lack of adequate inferential analyses</p></div></dd></dl><dl class="bkr_refwrap"><dt>3</dt><dd><div id="cha1.tab4_3"><p class="no_margin">Downgraded for serious indirectness as the participants were some of the “most severely affected” patients with cerebral palsy, and the definition of the outcome does not allow for a comparison between the two treatment periods to be made.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobcha1appbtab1"><div id="cha1.appb.tab1" class="table"><h3><span class="label">Table 6</span><span class="title">Last searched on 22 March 2018</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK578070/table/cha1.appb.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__cha1.appb.tab1_lrgtbl__"><table><thead><tr><th id="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">#</th><th id="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Searches</th></tr></thead><tbody><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Cerebral Palsy/ use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">2</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp cerebral palsy/ use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">3</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">((cerebral or brain or central) adj2 (pal* or paralys#s or pares#s)).tw.</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">4</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">cerebral palsy.ti,ab.</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">5</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">little? disease.tw.</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">6</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">((hemipleg* or dipleg* or tripleg* or quadripleg* or unilateral*) adj5 spastic*).tw.</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">7</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">((hemipleg* or dipleg* or tripleg* or quadripleg* or unilateral*) adj3 ataxi*).tw.</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">8</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/1–6</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">9</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">limit 8 to english language</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">10</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">limit 9 to (adult <18 to 64 years> or aged <65+ years>) use oemezd [Limit not valid in Ovid MEDLINE(R),Ovid MEDLINE(R) In-Process; records were retained]</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">11</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">limit 9 to “all adult (19 plus years)” [Limit not valid in Embase; records were retained]</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">12</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">11 use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">13</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/10,12</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">14</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Muscle Spasticity/ use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">15</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp spasticity/ use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">16</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">spastic*.tw.</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">17</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Dystonia/</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">18</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">dystoni*.ti,ab.</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">19</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">abnormal muscle tone.ti,ab.</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">20</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">14 or 15 or 16 or 17 or 18 or 19</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">21</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp Muscle Spasticity/ or exp Dystonia/ or exp Infusion Pumps, Implantable/ or exp Physical Therapy Modalities/ or exp Rhizotomy/ or exp Splints/ or exp Orthotic Devices/ or exp Deep Brain Stimulation/ or exp Baclofen/ad, ae, tu or exp Botulinum Toxins/ad, ae, tu or exp Diazepam/ad, ae, tu or exp Cannabinoids/ad, ae, tu or exp Acetylcholine Release Inhibitors/ad, ae, tu or exp Muscle Relaxants, Central/ad, ae, tu or exp Levodopa/ad, ae, tu or exp Dantrolene/ad, ae, tu or exp Clonazepam/ad, ae, tu or exp Pregabalin/ad, ae, tu or exp Clonidine/ad, ae, tu or exp Trihexyphenidyl/ad, ae, tu or exp Tetrabenazine/ad, ae, tu or exp Anti-Dyskinesia Agents/ad, ae, tu</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">22</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">21 use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">23</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp implantable infusion pump/ or exp physiotherapy/ or exp dorsal rhizotomy/ or exp splint/ or exp orthosis/ or exp brain depth stimulation/ or exp baclofen/ae, ad, cb, dt or exp botulinum toxin/ae, ad, cb, dt or exp diazepam/ae, ad, cb, dt or exp cannabinoid/ae, ad, cb, dt or exp acetylcholine release inhibitor/ae, ad, cb, dt or exp central muscle relaxant/ae, ad, cb, dt or exp levodopa/ae, ad, cb, dt or exp tizanidine/ae, ad, cb, dt or exp gabapentin/ae, ad, cb, dt or exp dantrolene/ae, ad, cb, dt or exp clonazepam/ae, ad, cb, dt or exp pregabalin/ae, ad, cb, dt or exp clonidine/ae, ad, cb, dt or exp trihexyphenidyl/ae, ad, cb, dt or exp tetrabenazine/ae, ad, cb, dt</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">24</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">23 use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">25</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(physiotherap* or botulinum or baclofen or tizanidine or intrathecal baclofen pump or gabapentin or levodopa or dantrolene or clonazepam or pregabalin or clonidine or dorsal rhizotomy or tetrabenazine or trihexyphenidyl or lycra or DBS or deep brain stimulat* or splint* or serial cast*).ti,ab.</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">26</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">22 or 24 or 25</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">27</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">13 and 20</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">28</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">13 and 26</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">29</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">27 or 28</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">30</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">conference abstract.pt. use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">31</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">letter.pt. or LETTER/ use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">32</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Letter/ use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">33</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">EDITORIAL/ use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">34</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">editorial.pt. use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">35</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">NEWS/ use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">36</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp HISTORICAL ARTICLE/ use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">37</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">note.pt. use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">38</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ANECDOTES AS TOPIC/ use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">39</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">COMMENT/ use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">40</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CASE REPORT/ use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">41</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CASE REPORT/ use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">42</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CASE STUDY/ use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">43</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(letter or comment* or abstracts).ti.</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">44</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/30–43</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">45</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RANDOMIZED CONTROLLED TRIAL/ use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">46</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RANDOMIZED CONTROLLED TRIAL/ use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">47</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">random*.ti,ab.</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">48</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/45–47</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">49</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">44 not 48</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">50</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ANIMALS/ not HUMANS/ use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">51</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ANIMAL/ not HUMAN/ use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">52</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp ANIMALS, LABORATORY/ use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">53</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp ANIMAL EXPERIMENTATION/ use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">54</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp MODELS, ANIMAL/ use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">55</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp RODENTIA/ use prmz</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">56</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">NONHUMAN/ use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">57</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp ANIMAL EXPERIMENT/ use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">58</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp EXPERIMENTAL ANIMAL/ use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">59</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ANIMAL MODEL/ use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">60</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">exp RODENT/ use oemezd</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">61</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">(rat or rats or mouse or mice).ti.</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">62</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">or/49–61</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">63</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">29 not 62</td></tr><tr><td headers="hd_h_cha1.appb.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">64</td><td headers="hd_h_cha1.appb.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">remove duplicates from 63</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobcha1appbtab2"><div id="cha1.appb.tab2" class="table"><h3><span class="label">Table 7</span><span class="title">Last searched on 22 March 2018</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK578070/table/cha1.appb.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__cha1.appb.tab2_lrgtbl__"><table><thead><tr><th id="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">#1</th><th id="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">MeSH descriptor: [Cerebral Palsy] explode all trees</th></tr></thead><tbody><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#2</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">((cerebral or brain or central) N2 (pal* or paralys?s or pare?s))</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#3</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">((hemipleg* or dipleg* or tripleg* or quadripleg* or unilateral*) N5 spastic*)</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#4</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">((hemipleg* or dipleg* or tripleg* or quadripleg* or unilateral*) N3 ataxi*)</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#5</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#1 or #2 or #3 or #4</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#6</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Muscle Spasticity] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#7</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Dystonia] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#8</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Dystoni* or spastic*</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#9</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#6 or #7 or #8</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#10</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Baclofen] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#11</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Botulinum Toxins] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#12</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Diazepam] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#13</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Cannabinoids] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#14</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Acetylcholine Release Inhibitors] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#15</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Muscle Relaxants, Central] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#16</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Infusion Pumps, Implantable] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#17</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Levodopa] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#18</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Physical Therapy Modalities] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#19</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">physiotherap* or Botulinum or baclofen or tizanidine or intrathecal pump or gabapentin or levodopa</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#20</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Dantrolene] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#21</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Clonazepam] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#22</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Pregabalin] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#23</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Clonidine] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#24</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Trihexyphenidyl] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#25</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Rhizotomy] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#26</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Splints] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#27</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Orthotic Devices] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#28</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Deep Brain Stimulation] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#29</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MeSH descriptor: [Tetrabenazine] explode all trees</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#30</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Tetrabenazine or Deep Brain Stimulation or DBS or Splint* or orthotic* or dorsal Rhizotomy or Trihexyphenidyl or Clonidine or Pregabalin or Clonazepam or Dantrolene or serial cast* or lycra or splint cast*</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#31</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 or #22 or #23 or #24 or #25 or #26 or #27 or #28 or #29 or #30</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#32</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#5 and #31</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#33</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#5 and #9</td></tr><tr><td headers="hd_h_cha1.appb.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#34</td><td headers="hd_h_cha1.appb.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#32 or #33</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobcha1appbtab3"><div id="cha1.appb.tab3" class="table"><h3><span class="label">Table 8</span><span class="title">Last searched on 27 March 2018</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK578070/table/cha1.appb.tab3/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__cha1.appb.tab3_lrgtbl__"><table><thead><tr><th id="hd_h_cha1.appb.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">#6</th><th id="hd_h_cha1.appb.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">#5 OR #3</th></tr></thead><tbody><tr><td headers="hd_h_cha1.appb.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#5</td><td headers="hd_h_cha1.appb.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#4 AND #1</td></tr><tr><td headers="hd_h_cha1.appb.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#4</td><td headers="hd_h_cha1.appb.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ts=spasticity or ts=spastic* or ts=dystonia or ts=dystoni*</td></tr><tr><td headers="hd_h_cha1.appb.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#3</td><td headers="hd_h_cha1.appb.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#2 AND #1</td></tr><tr><td headers="hd_h_cha1.appb.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#2</td><td headers="hd_h_cha1.appb.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ts=physiotherap* or ts=Botulinum or ts=baclofen or ts=tizanidine or ts=intrathecal pump or ts=gabapentin or ts=levodopa or ts=Muscle Relaxant* or ts=Acetylcholine Release Inhibitor* or ts=Cannabinoid* or ts=Diazepam or ts=Tetrabenazine or ts=Deep Brain Stimulation or ts=DBS or ts=Splint* or ts=orthotic* or ts=dorsal Rhizotomy or ts=Trihexyphenidyl or ts=Clonidine or ts=Pregabalin or ts=Clonazepam or ts=Dantrolene or ts=serial cast* or ts=lycra or ts=splint cast*</td></tr><tr><td headers="hd_h_cha1.appb.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">#1</td><td headers="hd_h_cha1.appb.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">ts=Cerebral Palsy</td></tr></tbody></table></div></div></article><article data-type="fig" id="figobcha1appcfig1"><div id="cha1.appc.fig1" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%201.%20Flow%20diagram%20of%20clinical%20article%20selection%20for%20pharmacological%20treatments%20for%20spasticity%20review.&p=BOOKS&id=578070_cha1appcf1.jpg" target="tileshopwindow" class="inline_block pmc_inline_block ts_canvas img_link" title="Click on image to zoom"><div class="ts_bar small" title="Click on image to zoom"></div><img data-src="/books/NBK578070/bin/cha1appcf1.jpg" alt="Figure 1. Flow diagram of clinical article selection for pharmacological treatments for spasticity review." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 1</span><span class="title">Flow diagram of clinical article selection for pharmacological treatments for spasticity review</span></h3></div></article><article data-type="fig" id="figobcha1appefig1"><div id="cha1.appe.fig1" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%202.%20Motor%20function%3A%206%20minute%20Walk%20Test.&p=BOOKS&id=578070_cha1appef1.jpg" target="tileshopwindow" class="inline_block pmc_inline_block ts_canvas img_link" title="Click on image to zoom"><div class="ts_bar small" title="Click on image to zoom"></div><img data-src="/books/NBK578070/bin/cha1appef1.jpg" alt="Figure 2. Motor function: 6 minute Walk Test." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 2</span><span class="title">Motor function: 6 minute Walk Test</span></h3><div class="caption"><p>CI: confidence interval; IV: inverse variance; SD: standard deviation; SE: standard error</p></div></div></article><article data-type="fig" id="figobcha1appefig2"><div id="cha1.appe.fig2" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%203.%20Motor%20function%3A%20Timed%20Up%20and%20Go.&p=BOOKS&id=578070_cha1appef2.jpg" target="tileshopwindow" class="inline_block pmc_inline_block ts_canvas img_link" title="Click on image to zoom"><div class="ts_bar small" title="Click on image to zoom"></div><img data-src="/books/NBK578070/bin/cha1appef2.jpg" alt="Figure 3. Motor function: Timed Up and Go." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 3</span><span class="title">Motor function: Timed Up and Go</span></h3><div class="caption"><p>CI: confidence interval; IV: inverse variance; SD: standard deviation; SE: standard error</p></div></div></article><article data-type="fig" id="figobcha1appefig3"><div id="cha1.appe.fig3" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%204.%20Muscle%20tone.&p=BOOKS&id=578070_cha1appef3.jpg" target="tileshopwindow" class="inline_block pmc_inline_block ts_canvas img_link" title="Click on image to zoom"><div class="ts_bar small" title="Click on image to zoom"></div><img data-src="/books/NBK578070/bin/cha1appef3.jpg" alt="Figure 4. Muscle tone." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 4</span><span class="title">Muscle tone</span></h3><div class="caption"><p>CI: confidence interval; IV: inverse variance; SD: standard deviation; SE: standard error</p></div></div></article><article data-type="fig" id="figobcha1appefig4"><div id="cha1.appe.fig4" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%205.%20Health%20related%20quality%20of%20life%20(SF-36).&p=BOOKS&id=578070_cha1appef4.jpg" target="tileshopwindow" class="inline_block pmc_inline_block ts_canvas img_link" title="Click on image to zoom"><div class="ts_bar small" title="Click on image to zoom"></div><img data-src="/books/NBK578070/bin/cha1appef4.jpg" alt="Figure 5. Health related quality of life (SF-36)." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 5</span><span class="title">Health related quality of life (SF-36)</span></h3><div class="caption"><p>CI: confidence interval; IV: inverse variance; SD: standard deviation; SE: standard error; SF-36: 36-Item Short Form Health Survey</p></div></div></article><article data-type="fig" id="figobcha1appefig5"><div id="cha1.appe.fig5" class="figure bk_fig"><div class="graphic"><a href="/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Figure%206.%20Patient%20reported%20satisfaction.&p=BOOKS&id=578070_cha1appef5.jpg" target="tileshopwindow" class="inline_block pmc_inline_block ts_canvas img_link" title="Click on image to zoom"><div class="ts_bar small" title="Click on image to zoom"></div><img data-src="/books/NBK578070/bin/cha1appef5.jpg" alt="Figure 6. Patient reported satisfaction." class="tileshop" title="Click on image to zoom" /></a></div><h3><span class="label">Figure 6</span><span class="title">Patient reported satisfaction</span></h3><div class="caption"><p>CI: confidence interval; M-H: Mantel-Haenszel</p></div></div></article><article data-type="table-wrap" id="figobcha1appltab1"><div id="cha1.appl.tab1" class="table"><h3><span class="label">Table 13</span><span class="title">Research recommendation rationale</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK578070/table/cha1.appl.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__cha1.appl.tab1_lrgtbl__"><table><thead><tr><th id="hd_h_cha1.appl.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Research question</th><th id="hd_h_cha1.appl.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Is guided Botulinum Toxin A injection using electrical localisation (electrical stimulation or electromyography) of muscles more effective and cost-effective than ultrasound guided or clinical positioning for localisation of injections in treating focal spasticity in adults with cerebral palsy?</th></tr></thead><tbody><tr><td headers="hd_h_cha1.appl.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Importance to ‘patients’ or the population</td><td headers="hd_h_cha1.appl.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The procedure does cause some discomfort and may be repeated after some months. Injection of the wrong muscle is a significant risk without accurate localisation. It is important that the patient gets maximum benefit from the procedure. It is preferable if this service is available as close to the person’s home as possible and skills in localising muscles and equipment may not be readily available in local injecting centres</td></tr><tr><td headers="hd_h_cha1.appl.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Relevance to NICE guidance</td><td headers="hd_h_cha1.appl.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Ability to advise clinicians and service managers the most effective way to deliver the treatment</td></tr><tr><td headers="hd_h_cha1.appl.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Relevance to the NHS</td><td headers="hd_h_cha1.appl.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The drug itself is costly. It does have beneficial effect for this patient group. This would allow a more cost effective service to be established</td></tr><tr><td headers="hd_h_cha1.appl.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">National priorities</td><td headers="hd_h_cha1.appl.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Encourage equitable access geographically to an effective service</td></tr><tr><td headers="hd_h_cha1.appl.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Current evidence base</td><td headers="hd_h_cha1.appl.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>There is some evidence including a systematic review showing that ultrasound or muscle stimulation is more accurate in placement of injection compared to manual identification of muscle in people with spasticity following stroke. This did not include cost effectiveness</p>
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<p>Chan 2017</p>
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<p>Clinical Rehabilitation. 2017 Jun;31(6):713–721.</p>
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<p>Does the method of botulinum neurotoxin injection for limb spasticity affect outcomes? A systematic review.</p>
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</td></tr><tr><td headers="hd_h_cha1.appl.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Equality</td><td headers="hd_h_cha1.appl.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Applies to all adults with cerebral palsy who have focal spasticity</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobcha1appltab2"><div id="cha1.appl.tab2" class="table"><h3><span class="label">Table 14</span><span class="title">Research recommendation modified PICO table</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK578070/table/cha1.appl.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__cha1.appl.tab2_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_cha1.appl.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Criterion</th><th id="hd_h_cha1.appl.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Explanation</th></tr></thead><tbody><tr><td headers="hd_h_cha1.appl.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</td><td headers="hd_h_cha1.appl.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adults with cerebral palsy who would benefit from Botulinum Toxin A Injections for focal spasticity</td></tr><tr><td headers="hd_h_cha1.appl.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention</td><td headers="hd_h_cha1.appl.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul id="l97"><li id="lt331" class="half_rhythm"><div>Muscle stimulation or EMG guided Botulinum Toxin A Injection</div></li><li id="lt332" class="half_rhythm"><div>Ultrasound guided Botulinum Toxin Injection</div></li></ul></td></tr><tr><td headers="hd_h_cha1.appl.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparator</td><td headers="hd_h_cha1.appl.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Clinical positioning for localisation for Botulinum Toxin A injection or each other</td></tr><tr><td headers="hd_h_cha1.appl.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcome</td><td headers="hd_h_cha1.appl.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul id="l98"><li id="lt333" class="half_rhythm"><div>Reduction in muscle tone at 8 weeks and 4 months</div></li><li id="lt334" class="half_rhythm"><div>Side effects using patient/carer questionnaire</div></li><li id="lt335" class="half_rhythm"><div>Patient acceptability</div></li><li id="lt336" class="half_rhythm"><div>Goal attainment score</div></li><li id="lt337" class="half_rhythm"><div>Time to repeat injection or alternative management</div></li><li id="lt338" class="half_rhythm"><div>Frequency of post-infiltration physiotherapy and casting</div></li><li id="lt339" class="half_rhythm"><div>Cost per injection episode</div></li></ul></td></tr><tr><td headers="hd_h_cha1.appl.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study design</td><td headers="hd_h_cha1.appl.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Randomised. Assessor of muscle tone would be blinded to technique. Patient and injector would not be blinded</td></tr><tr><td headers="hd_h_cha1.appl.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Timeframe</td><td headers="hd_h_cha1.appl.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">2 years</td></tr><tr><td headers="hd_h_cha1.appl.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Additional information</td><td headers="hd_h_cha1.appl.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Could stratify for upper limb (smaller muscles) and lower limb as there would be different functional goals.</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">EMG: Electromyography</p></div></dd></dl></dl></div></div></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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