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<div class="pre-content"><div><div class="bk_prnt"><p class="small">NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.</p><p>National Collaborating Centre for Primary Care (UK). Low Back Pain: Early Management of Persistent Non-specific Low Back Pain [Internet]. London: Royal College of General Practitioners (UK); 2009 May. (NICE Clinical Guidelines, No. 88.)</p></div><div class="bk_msg_box bk_bttm_mrgn clearfix bk_noprnt"><div class="iconblock clearfix"><a class="img_link icnblk_img" title="Table of Contents Page" href="/books/n/niceng59guid/"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-niceng59guid-lrg.png" alt="Cover" height="100px" width="80px" /></a><div class="icnblk_cntnt"><ul class="messages"><li class="info icon"><span class="icon"><a href="/books/n/niceng59guid/">A new version of this title is available</a></span></li></ul></div></div></div><div class="messagearea bk_noprnt" style="margin-bottom:1.3846em "><ul class="messages"><li class="warn icon"><span class="icon">This publication is provided for historical reference only and the information may be out of date.</span></li></ul></div><div class="bk_prnt"><p style="color:red;"><strong>This publication is provided for historical reference only and the information may be out of date.</strong></p></div><div class="iconblock clearfix whole_rhythm no_top_margin bk_noprnt"><a class="img_link icnblk_img" title="Table of Contents Page" href="/books/n/nicecg88/"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-nicecg88-lrg.png" alt="Cover of Low Back Pain" height="100px" width="80px" /></a><div class="icnblk_cntnt eight_col"><h2>Low Back Pain: Early Management of Persistent Non-specific Low Back Pain [Internet].</h2><a data-jig="ncbitoggler" href="#__NBK11705_dtls__">Show details</a><div style="display:none" class="ui-widget" id="__NBK11705_dtls__"><div>NICE Clinical Guidelines, No. 88.</div><div>National Collaborating Centre for Primary Care (UK).</div><div>London: <a href="https://www.rcgp.org.uk/" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">Royal College of General Practitioners (UK)</a>; 2009 May.</div></div><div class="half_rhythm"><ul class="inline_list"><li style="margin-right:1em"><a class="bk_cntns" href="/books/n/nicecg88/">Contents</a></li></ul></div></div><div class="icnblk_cntnt two_col"><div class="pagination bk_noprnt"><a class="active page_link prev" href="/books/n/nicecg88/ch9/" title="Previous page in this title">< Prev</a><a class="active page_link next" href="/books/n/nicecg88/ch11/" title="Next page in this title">Next ></a></div></div></div></div></div>
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<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><h1 id="_NBK11705_"><span class="label"> 10</span><span class="title" itemprop="name">Psychological interventions and mixed packages of care (combined physical and psychological interventions)</span></h1></div><div class="jig-ncbiinpagenav body-content whole_rhythm" data-jigconfig="allHeadingLevels: ['h2'],smoothScroll: false" itemprop="text"><div id="ch10.s1"><h2 id="_ch10_s1_">10.1. Introduction</h2><p>In this chapter, as well as considering psychological therapies used as a monotherapy, the GDG also considered the evidence for packages of care that were characterised by including both physical activity/exercise and psychological interventions. The decision for inclusion as a mixed package of care was based upon the reported content of the intervention rather than the profession of the practitioner delivering the intervention. It was difficult to determine in many studies which professions were involved in programme delivery. The intensity and duration of the interventions varied considerably between studies. Some interventions were delivered primarily by physiotherapists and others were delivered by a combination of professions. The GDG considered studies to be mixed packages of care or Combined Physical and Psychological (CPP) interventions if the content was broadly similar to that recommended in the ’Recommended Guidelines for Pain Management Programmes for Adults‘ issued by the British Pain Society (<a href="/books/n/nicecg88/ch12/#ch12.r21" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r21/" data-bk-pop-others="" class="bk_pop">British Pain Society., 2007</a>).</p><p>The GDG recognised the heterogeneity of the types of programmes in this section. Previous reviews undertaken in the development of this guideline had suggested that intense, and by implication, expensive programmes of long duration afforded no extra benefit over brief interventions for those who were assessed and identified at low or moderate risk of a poor outcome; only those at high risk of a poor outcome benefited from intense programmes. For this reason, the GDG looked at the literature on screening to identify which patients should be referred for these intensive treatments. The Health Economic implications of this are also considered and have informed the treatment pathway.</p></div><div id="ch10.s2"><h2 id="_ch10_s2_">10.2. Recommendations for combined physical and psychological treatment programme</h2><p><a href="#ch10.s10">Hyperlink to relevant evidence statements</a></p><dl class="temp-labeled-list"><dt>10.2.1.</dt><dd><p class="no_top_margin">Consider referral for a combined physical and psychological treatment programme, comprising around 100 hours over a maximum of 8 weeks, for people who:</p><ul><li class="half_rhythm"><div>have received at least one less intensive treatment <b>and</b></div></li><li class="half_rhythm"><div>have high disability and/or significant psychological distress</div></li></ul></dd><dt>10.2.2.</dt><dd><p class="no_top_margin">Combined physical and psychological treatment programmes should include a cognitive behavioural approach and exercise</p></dd></dl></div><div id="ch10.s3"><h2 id="_ch10_s3_">10.3. Psychological Screening</h2><p>Clinical question: is psychosocial/psychological screening effective/cost effective at identifying which patients may gain the <u>greatest benefit</u> from either general or specific treatments?</p><div id="ch10.s4"><h3>10.3.1. Clinical evidence</h3><p>One RCT invited people to participate who had a permanent job and had been sick-listed with musculoskeletal pain for 50% of the time during the previous 8 weeks, or those who had been sick-listed with musculoskeletal pain for at least 2 months per year for the last 2 years (<a href="/books/n/nicecg88/ch12/#ch12.r60" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r60/" data-bk-pop-others="" class="bk_pop">Haldorsen, Håland. E. M., Grasdal, Astrid. L., Skouen, Jan. Sture. et al, 2002</a>) Of 1988 patients approached 654 were included (1,175 declined to join and 159 were excluded). Of these 391 were in the intervention groups and 263 were in the control group.</p><p>The participants were screened using a psychological questionnaire and a physiotherapy examination to produce 3 groups according to their prognosis to return to work: good, medium and poor prognosis. These 3 groups were then randomised into 3 more groups for the type of treatment they would receive: ordinary treatment (control group), light multidisciplinary treatment and extensive multidisciplinary treatment. The outcome was the time taken to return to work. For those with a good prognosis of returning to work the type of treatment did not affect the time taken to return to work making ordinary treatment the best choice (after 14 months 63% had returned to work). For those with a medium prognosis of returning to work, the light multidisciplinary treatment was most effective (64% had returned to work after 14 months). For those with a poor prognosis of returning to work the extensive multidisciplinary treatment was most effective (55% had returned to work after 14 months).</p><p>This was a well conducted RCT with a low risk of bias</p></div><div id="ch10.s5"><h3>10.3.2. Health economics</h3><p>Two studies were found which were potentially relevant to the question regarding the cost-effectiveness of psychosocial screening. One was a cost benefit study (<a href="/books/n/nicecg88/ch12/#ch12.r60" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r60/" data-bk-pop-others="" class="bk_pop">Haldorsen, Håland. E. M., Grasdal, Astrid. L., Skouen, Jan. Sture. et al, 2002</a>) and one was a cost effectiveness study (<a href="/books/n/nicecg88/ch12/#ch12.r121" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r121/" data-bk-pop-others="" class="bk_pop">Skouen, J. S., Grasdal, A. L., Haldorsen, E. M. H. et al, 2002</a>) However, both studies were excluded for this question because they did not meet inclusion criteria for economic evaluations for this guideline. The studies did not include a relevant population. Rather, participants were long-term sick-listed employees and the main study outcome was return-to-work rates, which would not allow for a cost-per-QALY analysis. In addition, the economic analysis took a societal perspective rather than that of the health service, as recommended by NICE, and the setting was not the UK. However, data from both studies were used to help inform the economic model which was developed to estimate the cost effectiveness of combined physical and psychological interventions. For a description of the model see section 10.5.2.1</p></div><div id="ch10.s6"><h3>10.3.3. Evidence statements for psychosocial screening</h3><div id="ch10.t1" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK11705/table/ch10.t1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch10.t1_lrgtbl__"><table><thead><tr><th id="hd_h_ch10.t1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Evidence statements</th><th id="hd_h_ch10.t1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Evidence to recommendations</th></tr></thead><tbody><tr><td headers="hd_h_ch10.t1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<dl class="temp-labeled-list"><dt>10.3.3.1.</dt><dd><p class="no_top_margin">One well conducted RCT used a psychosocial screening instrument in adults with non-specific back pain to identify adults with a good, medium or poor prognosis for return to work. The screening instrument also included a physical assessment. Each category was randomised to receive one of three different treatments: ordinary, light multidisciplinary or extensive multidisciplinary. At 14 months follow up for the outcome of return to work, adults with a good prognosis did equally well in each treatment group. Adults with a medium prognosis did equally well in the light or intensive multidisciplinary treatment groups. Adults with a poor prognosis only had a similar percentage of return to work to the other prognosis groups if they received the multidisciplinary intervention.(1+) (<a href="/books/n/nicecg88/ch12/#ch12.r60" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r60/" data-bk-pop-others="" class="bk_pop">Haldorsen, Håland. E. M., Grasdal, Astrid. L., Skouen, Jan. Sture. et al, (2002)</a></p></dd><dt>10.3.3.2.</dt><dd><p class="no_top_margin">Although two health economic studies were identified as potentially useful for the question of psychosocial screening, they did not meet the inclusion criteria for economic evaluations.</p></dd></dl></td><td headers="hd_h_ch10.t1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The study found that people who, at baseline, had a poor prognosis who had more extensive multidisciplinary therapies were more likely to return to work; but that for those with a good prognosis a low-intensity treatment was just as effective as an intensive treatment one.<br />There is evidence from one RCT that screening for poor prognosis for return to work aids in identifying a group who gain greater benefit from compared to less intensive treatments.<br />The GDG agreed that there is some evidence that screening for those with a poor prognosis should be considered in order to inform treatment decisions and that consideration should be given to referring this group for more intensive treatments.<br />The GDG noted that this paper was specific to a sick listed population and the only outcome reported was return to work.<br />The group noted that this study also Identified those who were unlikely to need complex interventions.<br />However, at present there is insufficient evidence to make recommendations for the use of any specific screening instrument. The GDG agreed that a research recommendation should be made regarding what screening tools should be used to inform treatment decisions.<br />Health economics analysis - Although two economic studies were excluded because they did not meet inclusion criteria for economic evaluations in this guideline, data from both studies were used to help inform an economic model which was developed to estimate the cost effectiveness of combined packages of physical and psychological therapies.</td></tr></tbody></table></div></div></div></div><div id="ch10.s7"><h2 id="_ch10_s7_">10.4. Psychological Interventions</h2><p>Clinical question: what is the effectiveness of psychological interventions compared with usual care on pain, functional disability or psychological distress?</p><div id="ch10.s8"><h3>10.4.1. Clinical evidence</h3><p>A total of 2 RCTs were identified and included. Two recent systematic reviews were excluded for this question: a systematic review (<a href="/books/n/nicecg88/ch12/#ch12.r111" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r111/" data-bk-pop-others="" class="bk_pop">Ostelo, R. W. J. G., van Tulder, M. W., Vlaeyen, J. W. S. et al, 2005</a>) was excluded because included studies were too heterogeneous (relevant studies were ordered and assessed separately). A meta-analysis (<a href="/books/n/nicecg88/ch12/#ch12.r67" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r67/" data-bk-pop-others="" class="bk_pop">Hoffman, B. M., Papas, R. K., Chatkoff, D. K. et al, 2007</a>) was excluded because papers included in it were too heterogeneous in interventions (some included surgery, massage, mainly combined physical and psychological interventions) and population (some were post-surgical populations).</p><p>One randomised controlled trial compared the effects of a cognitive-behaviour intervention aimed at preventing chronicity with two different forms of information (<a href="/books/n/nicecg88/ch12/#ch12.r94" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r94/" data-bk-pop-others="" class="bk_pop">Linton, S. J. and Andersson, T., 2000</a>). Patients aged 18–60 with <3 months cumulative sick leave during the past year were recruited from local primary care facilities and randomly assigned to a cognitive-behaviour group intervention (n=107), a pamphlet group (n=70) and an information package group (n=66). Participants in the CBT group received 6 sessions of 2 hours duration once a week for 6 weeks. The programme was carried out in groups of 6–10 people. Each session consisted of a short review of homework, an introduction to the topic for the session; structured problem-solving followed by exercise. Subsequently, new skills were introduced, and participants were assigned homework. Patients in the pamphlet group received a previously evaluated pamphlet to read concerning back pain. It provided straightforward advice about the best way to cope with back pain by remaining active and thinking positively. It was aimed at preventing fear avoidance and promoting coping. Patients in the information package intervention group received a packet of information once a week for 6 weeks. The number and timing of the packages was meant to match that number of sessions the CBT group received. The material used more traditional sources of information and was based on a back school approach.</p><p>Although pain significantly improved in the CBT and pamphlet groups it did not significantly differ between groups. Fear avoidance decreased significantly in all groups but no significant between-group difference was observed.</p><p>This was a well conducted RCT with a low risk of bias.</p><p>One randomised controlled trial evaluated a cognitive-behaviour programme to enhance back pain self care (<a href="/books/n/nicecg88/ch12/#ch12.r105" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r105/" data-bk-pop-others="" class="bk_pop">Moore, James. E., Von Korff, Michael., Cherkin, Daniel. et al, 2000</a>). The authors evaluated a brief intervention for primary care back pain patients designed to provide accurate information about back pain. Patients enrolled in a large health maintenance organisation in the USA were invited to participate in an educational programme to improve back pain self care skills 6–8 weeks after a primary care back pain visit. Patients (n=226) were randomly assigned to a Self Care intervention (n=113) or to usual care (n=113) and were assessed at baseline, 3-, 6-, and 12-months. The intervention involved a 2-session self care group with the group leader, a psychologist experienced in pain management. Within 2 weeks of the group session each participant met individually with his or her leader for approximately 45 minutes to develop a personal self care plan. Leaders made one brief (3minute) follow up phone call to each participant to encourage continued action on the self care plan. The intervention was supplemented by educational materials (book and videos) supporting active management of back pain. The control group received usual care supplemented by a book on back pain care.</p><p>Results showed a greater reduction in average pain intensity for the self-care group than the usual care group, but the difference was significant only at 6 months (P <0.05). The self care group showed significantly lower fear-avoidance scale scores compared to the usual care group at all follow-up periods (P <0.01). At 3 months, the self care group reported significantly less disability than the usual care group on the Roland Morris Disability Questionnaire (P <0.05). The effect was no longer significant at 6 or 12 months. The self-care group did not show more favourable mental health outcomes than the usual care group.</p><p>This was a well conducted RCT with a low risk of bias.</p></div><div id="ch10.s9"><h3>10.4.2. Health economics</h3><p>No economic evaluations were identified for psychological therapies.</p></div><div id="ch10.s10"><h3>10.4.3. Evidence statements for psychological interventions</h3><div id="ch10.t2" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK11705/table/ch10.t2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch10.t2_lrgtbl__"><table><thead><tr><th id="hd_h_ch10.t2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Evidence statements</th><th id="hd_h_ch10.t2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Evidence to recommendations</th></tr></thead><tbody><tr><td headers="hd_h_ch10.t2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<dl class="temp-labeled-list"><dt>10.4.3.1.</dt><dd><p class="no_top_margin">One RCT compared a cognitive behavioural treatment to information/pamphlet and found no significant difference in improvement in pain at 12 months follow-up (1+) (<a href="/books/n/nicecg88/ch12/#ch12.r94" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r94/" data-bk-pop-others="" class="bk_pop">Linton, S. J. and Andersson, T., 2000</a>).</p></dd><dt>10.4.3.2.</dt><dd><p class="no_top_margin">One RCT compared a self care intervention to usual care. The intervention was psychologist-led. Disability was significantly reduced at 3 months, and pain was significantly reduced at 6 months follow-up. No effect was found on mental health (1+) (<a href="/books/n/nicecg88/ch12/#ch12.r105" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r105/" data-bk-pop-others="" class="bk_pop">Moore, James. E., Von Korff, Michael., Cherkin, Daniel. et al, 2000</a>)</p></dd><dt>10.4.3.3.</dt><dd><p class="no_top_margin">No cost effectiveness studies were identified for psychological therapies</p></dd></dl></td><td headers="hd_h_ch10.t2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">A number of randomised controlled trials presented were excluded by the GDG because they were not considered to be psychological interventions, or patients had had other co-interventions or were not compared with usual care.<br />This decision was reached by consensus.<br />The GDG agreed that there is evidence in pain management literature that there is benefit from psychological interventions on distress. References to this literature were supplied and the papers reviewed but no studies could be found that showed a significant effect in patients with low back pain as the main presenting condition.<br />There is limited evidence to support the use of psychological interventions as mono-therapy for non specific low back pain.<br />One study evaluated a brief intervention which included a 45 minute session with a psychologist which the group agreed should be included. This decision was reached by consensus.<br />GDG considered that the study had patients who were more severely affected by their pain and therefore a recommendation should be made for this particular group.<br />No evidence was found for longer treatments of psychological interventions delivered in the absence of concurrent or combined physical therapy. GDG decided by consensus that a recommendation be made for a combined treatment package rather than a standalone psychological intervention.<br />The group agreed that this was an area where further research was required.</td></tr></tbody></table></div></div></div></div><div id="ch10.s11"><h2 id="_ch10_s11_">10.5. Combined Physical and Psychological Therapy</h2><p>Clinical question: what is the effectiveness of combined interventions (comprising of physical and psychological therapies) compared with usual care/other interventions on pain, functional disability or psychological distress?</p><div id="ch10.s12"><h3>10.5.1. Clinical evidence</h3><p>A total of 11 RCTs (three with follow-up studies) were included.</p><p>One randomised controlled trial (<a href="/books/n/nicecg88/ch12/#ch12.r2" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r2/" data-bk-pop-others="" class="bk_pop">Alaranta, H., Rytokoski, U., Rissanen, A. et al, 1994</a>) assessed the effectiveness of an intensive physical and psychosocial training programme, described as Functional Restoration (FR) on patients with low back pain. This treatment was compared to a less intensive programme called current national type (CNT) during 15 to 20 hrs per week for 3 weeks versus 37 hours per week for 3 weeks for FR. The FR programme (n=152) consisted of cardiovascular exercises, muscular strength exercises, relaxation and rest periods, stretching and CBT group work. The CNT (n=141) consisted of a number of passive physical therapies, exercises, and back school education. The primary outcome appeared to be sick leave days. Secondary outcomes included pain and disability and psychological outcomes. Patients were aged between 30 and 47 and had pain for at least 6 months. Pain and disability improved more over 1 year in the FR group compared to the CNT group and the differences were statistically significant (P =0.011). Differences between the groups with regard to psychological outcomes were small. The process of randomisation was poorly reported. After randomisation and before treatment started, 85 patients (22%) were excluded because it was considered they were unfit to participate in the programmes, although the numbers excluded from each group were not reported. No sample size calculation was reported.</p><p>This was a RCT with a high risk of bias.</p><p>One randomised controlled trial (<a href="/books/n/nicecg88/ch12/#ch12.r12" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r12/" data-bk-pop-others="" class="bk_pop">Bendix, A. F., Bendix, T., Ostenfeld, S. et al, 1995</a>) aimed to determine if an active, multidisciplinary, intensive treatment programme (Functional Restoration (FR) was superior to other active but less intensive programmes at 4 months. Participants (n=132), sick-listed or without a job, were randomised to one of three programmes. FR consisted of attendance at the Copenhagen Back Centre, University Hospital, for 39 hours per week (8am to 4pm) for 3 successive weeks. This was followed by 1 day a week for the next 3 weeks. It included aerobics, weight training, work simulation, relaxation, psychological group work, stretching, theoretical class and recreational activities. Physical training (PT) comprised aerobics, weight training and back school in 2- hour sessions twice a week for 6 weeks. Psychological and physical training (PPT) comprised physical training as well as pain management in 2-hour sessions twice a week for six weeks. The primary outcome was the return-to-work rate. Secondary outcomes included, among other measures, pain and function. Results showed that the FR programme was superior to the less intensive treatments and that differences between groups were statistically significant. Results on one, two and five year follow-up are reported separately (<a href="/books/n/nicecg88/ch12/#ch12.r9" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r9/" data-bk-pop-others="" class="bk_pop">Bendix, A. E., Bendix, T., Haestrup, C. et al, 1998</a>; <a href="/books/n/nicecg88/ch12/#ch12.r10" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r10/" data-bk-pop-others="" class="bk_pop">Bendix, A. F., Bendix, T., Labriola, M. et al, 1998</a>; <a href="/books/n/nicecg88/ch12/#ch12.r11" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r11/" data-bk-pop-others="" class="bk_pop">Bendix, A. F., Bendix, T., Lund, C. et al, 1997</a>). The follow-up periods were defined as the first Monday after three weeks of treatment, regardless of the treatment duration, plus 13 months, two years and five years respectively. They found statistically significant differences in pain scores and function scores between the three groups in favour of intensive FR at both one and two years (P =0.005 and P >0.001 at one year, P =0.008 and P =0.003 at 2 years). At five years they found a statistically significant difference in function (P <0.001), but not pain in favour of FR.</p><p>No sample size calculation was reported. The process of randomisation was not described.</p><p>This was a RCT with a high risk of bias</p><p>One randomised controlled trial (<a href="/books/n/nicecg88/ch12/#ch12.r11" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r11/" data-bk-pop-others="" class="bk_pop">Bendix, A. F., Bendix, T., Vaegter, K. et al, 1996</a>) reports on whether a 3-week, 39 hours per week, multidisciplinary programme based at the Copenhagen Back Center would affect the return-to-work rate, the number of days of sick leave used, the number of contacts with health care providers, pain and disability levels and muscle endurance in patients with chronic LBP (at least 6 months). Fifty-five participants were randomised to the intervention group and 51 to the control group. The latter could choose to go anywhere else for treatment or choose to have no treatment. A typical day for the intervention group consisted of aerobics, weight training, work simulation, relaxation, psychological group work, stretching, theoretical class, and recreation. At study end (4 months after treatment ended) the intervention group had improved more with regard to pain and disability than the control group and the differences were statistically significant (P =0.05 and P <0.001 respectively). Results from the two and five year follow-up are reported separately (<a href="/books/n/nicecg88/ch12/#ch12.r9" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r9/" data-bk-pop-others="" class="bk_pop">Bendix, A. E., Bendix, T., Haestrup, C. et al, 1998</a>; <a href="/books/n/nicecg88/ch12/#ch12.r10" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r10/" data-bk-pop-others="" class="bk_pop">Bendix, A. F., Bendix, T., Labriola, M. et al, 1998</a>). The follow-up periods were defined as the first Monday after three weeks of treatment, regardless of the treatment duration, plus two years and five years respectively. They found no statistically significant differences in pains cores or function scores between the two groups at two and five years follow-up. The study randomisation was not described and no sample size calculations are reported.</p><p>This was a RCT with a high risk of bias.</p><p>One randomised controlled trial (<a href="/books/n/nicecg88/ch12/#ch12.r14" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r14/" data-bk-pop-others="" class="bk_pop">Bendix, T., Bendix, A., Labriola, M. et al, 2000</a>) compared an intensive multidisciplinary functional restoration (FR) programme (n=64) with an intensive outpatient-based physical training (PT) programme (n=74). FR consisted of 3 weeks (39 hours per week) aerobic exercises, fitness machine exercises, occupational therapy, group psychology therapy, stretching exercises, back pain theory and recreational activities. PT consisted of aerobic and strengthening exercises 1.5 hours, three times per week for 8 weeks. At 1 year no difference was found between groups with regard to work capability, sick leave, health care contacts, back pain, leg pain or self-reported activities of daily living. There was a statistically significant improvement in quality of life (as measured by the individual on a 5-point scale) in favour of the FR group. This study did not specify a primary outcome, and did not present a sample size calculation. The drop out rate was relatively high.</p><p>This was a RCT with a high risk of bias</p><p>One randomised controlled trial (<a href="/books/n/nicecg88/ch12/#ch12.r32" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r32/" data-bk-pop-others="" class="bk_pop">Corey, D. T., Koepfler, L. E., Etlin, D. et al, 1996</a>) compared the efficacy of a limited functional restoration (FR) programme over “usual care”. The FR group (n=100) spent a maximum of 6.5 hours per day over an average of 33 days doing a multidisciplinary therapy: stretching, strengthening and endurance building, work hardening, and education in posture and body mechanics. They also had group education and counselling. They were taught active pain management strategies, stress management and a multidimensional theory of pain. The usual care group (n=100) were discharged to the care of their physician with a letter advising proactive management including advice to encourage activity despite pain. The FR group reported less pain at 18 months compared to the usual care group and the difference was statistically significant (P =0.008). This study did not specify a primary outcome, and did not present a sample size calculation. The drop out rate was relatively high.</p><p>This was a RCT with a high risk of bias</p><p>A randomised controlled trial based at two London hospitals (<a href="/books/n/nicecg88/ch12/#ch12.r34" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r34/" data-bk-pop-others="" class="bk_pop">Critchley, D. J., Ratcliffe, J., Noonan, S. et al, 2007</a>) compared the effectiveness of three kinds of physiotherapy in participants with chronic LBP (> 12 weeks duration) at 18 months follow-up. Individual physiotherapy (IP) consisted of a combination of joint mobilizations, joint manipulation, and massage. It also included taught exercises for performing at home, and usually back care advice. Up to 12 sessions of around 30 minutes were permitted. Spinal stabilisation (SS) consisted of specific muscle training followed by group exercises for SS. Up to 8 sessions of 90 minutes each were allowed. The pain management programme (PM) consisted of a combination of structured back pain education with group exercises (strengthening, stretching and light aerobic). A CBT approach was used. The program consisted of a maximum of 8 sessions of 90 minutes each.</p><p>The number of participants in each group were 71(IP), 72(SS) and 69(PM). They were over 18 years and had a good command of English. Average time since their first episode of back pain was at least 5 years. Primary outcome was the RMDQ. Secondary outcomes included pain score, EQ-5D and time off work. At 18 months all three groups had improved on the RMDQ and the pain score from baseline, and there were no significant differences between the three groups. Attrition was 17% in the IP group, 25% in the SS group and 32% in the PM group.</p><p>This was a RCT with a high risk of bias.</p><p>One randomised controlled trial (<a href="/books/n/nicecg88/ch12/#ch12.r48" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r48/" data-bk-pop-others="" class="bk_pop">Friedrich, M., Gittler, G., Halberstadt, Y. et al, 1998</a>) compared the effectiveness of an exercise+motivational programme (n=49) to an exercise only programme (n=49) in an RCT in participants aged 20 to 60 years. Outcomes included pain and disability at 12 months. Both groups received an individualised, gradually increased, exercise programme consisting of 10 sessions of 25 minutes each. The intervention group also took part in a motivational programme (length and duration of sessions not reported) which comprised extensive counselling, reinforcement techniques, oral and written agreements between patient and therapist, and maintaining an exercise diary to discuss with therapist. There was a statistically significant improvement in terms of pain and disability at 12 months in the motivational group compared to the exercise along group (P =0.006 and P =0.004). Results from 5 years follow-up (<a href="/books/n/nicecg88/ch12/#ch12.r47" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r47/" data-bk-pop-others="" class="bk_pop">Friedrich, M., Gittler, G., Arendasy, M. et al, 2005</a>) showed pain intensity to be much lower for the motivational group (15 versus 45 for the control group) and the difference was statistically significant (P =0.001). Mean differences for the groups for disability were not reported. A regression analysis was conducted and from that the study reported that the cumulative effect in the motivational group was twice that in the control group. The study had a high risk of bias: randomisation not described, no primary outcome specified and no sample size calculation was reported. In addition, the drop out rate was high.</p><p>One randomised controlled trial (<a href="/books/n/nicecg88/ch12/#ch12.r81" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r81/" data-bk-pop-others="" class="bk_pop">Kääpä, Eeva Helena, Frantsi, Kirsi, Sarna, Seppo et al, 2006</a>) compared the effectiveness of a semi-intensive multidisciplinary rehabilitation (MR) for patients with chronic low back pain with individual physiotherapy in an outpatient setting in Finland. All the participants were women employed as healthcare and social care professionals with non-specific chronic LBP. The MR programme (n=59) consisted of 70 hours over 8 weeks. It comprised psychological CBT stress management, a back school programme, instruction in work ergonomics, and a physical exercise programme. The control group (n=61) received 10 hours of individual physiotherapy over 6 to 8 weeks. Each session included passive pain treatment and 15 to 20 minutes of light active exercise. In addition, they were given a home-exercise programme and advised to gradually increase their daily activities. There were no significant differences between the intervention and control group at 24 months with regard to pain intensity, disability or depression.</p><p>This was a well conducted RCT with a low risk of bias.</p><p>One randomised controlled trial (<a href="/books/n/nicecg88/ch12/#ch12.r85" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r85/" data-bk-pop-others="" class="bk_pop">Keller, S., Ehrhardt, Schmelzer S., Herda, C. et al, 1997</a>) compared a multidisciplinary rehabilitation (MR) programme (n=36) with a waiting list control group (n=36). The MR programme consisted of 18 2-hour group meetings (3 per week) in addition to 18 individualised training sessions (two patients with one trainer) of 30 minute duration in an outpatient setting. Treatment was administered by a multidisciplinary team including physicians and physiotherapists with training in pain management strategies, and supervised by a clinical psychologist. It included elements of education, relaxation and exercise. For ethical reasons the study investigators were not allowed to withhold the MR therapy from the controls, and therefore the control group received the same rehabilitation programme after the intervention group had finished theirs. Consequently no 6-month follow-up comparisons between the intervention and control groups could be conducted because both had received the same treatment by this time. The only comparative data results show that immediately post-treatment (before the controls were treated) pain intensity and disability were significantly reduced as a consequence of the treatment. The randomisation process was not described, no primary outcome was specified and the dropout rate was high.</p><p>This was a RCT with a high risk of bias.</p><p>One randomised controlled trial (<a href="/books/n/nicecg88/ch12/#ch12.r122" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r122/" data-bk-pop-others="" class="bk_pop">Smeets, Rob. J. E. M., Vlaeyen, Johan. W. S., Hidding, Alita. et al, 2008</a>) compared combined therapy (CT) of graded activity and problem solving (GAP) plus active physical training (APT) with either GAP or APT alone. Patients aged 18 to 65 with LBP > 3 months were recruited into one of three groups GAP (n=53), APT (n=58) and CT (n=51). APT included 3 sessions per week over 10 weeks. Each session consisted of 30 minutes aerobic training and 75 minutes of strength and endurance training supervised by a physiotherapist. GAP started with graded activity (GA): 3 group sessions followed by a maximum of 17 individual sessions of 30 minutes. Problem solving training (PST) was lead by a clinical psychologist and consisted of 10 sessions of 1.5 hours with a maximum of 4 patients at a time. Although patients in all three groups improved over time, at 12 months, the level of disability, main complaints, pain, depression and performance tasks did not differ significantly between treatments.</p><p>This was a well conducted RCT with a low risk of bias.</p><p>One randomised controlled trial (<a href="/books/n/nicecg88/ch12/#ch12.r128" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r128/" data-bk-pop-others="" class="bk_pop">Tavafian, Sedigheh Sadat, Jamshidi, Ahmadreza, Mohammad, Kazem et al, 2007</a>) compared a back school (n=50) with usual care which consisted of medication (paracetamol, NSAID, and chlordiazepoxide) (n=52) for Iranian women with LBP >90 days. Follow-up was at 3 months. The back school consisted of a four-day, five-session programme in which women were “educated” by an educator (beliefs about LBP), a clinical psychologist (coping skills) and a physical trainer (stabilising and strengthening exercises). This group were also taking the same medication as the usual care group. The outcome of interest was quality of life as measured by the SF-36 which includes two dimensions that measure physical functioning and bodily pain. The study reports that the difference between the groups was statistically significant in favour of the back school but does not present the results of that analysis or any p values.</p><p>This was a RCT with a high risk of bias.</p></div><div id="ch10.s13"><h3>10.5.2. Health economics</h3><p>The GDG was interested in combined physical and psychological interventions provided on an intensive and less intensive level. The literature was reviewed and further modelling considered for this question.</p><div id="ch10.s14"><h4>Evidence review</h4><p>One study was included. Initially included for the educational intervention question, the GDG felt it was more appropriate to use this evidence for the combined programmes covered by this question. It was a UK-based cost-effectiveness study of three interventions for treatment of low back pain. This paper was deemed useful for helping to answer the question concerning low intensity CPP (<a href="/books/n/nicecg88/ch12/#ch12.r34" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r34/" data-bk-pop-others="" class="bk_pop">Critchley, D. J., Ratcliffe, J., Noonan, S. et al, 2007</a>).</p><p>This cost utility analysis was conducted alongside a pragmatic randomized clinical trial to compare three types of physiotherapy commonly used to reduce disability in chronic low back pain (<a href="/books/n/nicecg88/ch12/#ch12.r34" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r34/" data-bk-pop-others="" class="bk_pop">Critchley, D. J., Ratcliffe, J., Noonan, S. et al, 2007</a>). The study randomized 212 patients aged 18 years or older, who had LBP of more than 12 weeks to: individual physiotherapy (n=71) in which patients were assessed and treated according to assessment findings for up to 12 sessions of around 30 minutes; spinal stabilisation (n=72) which consisted of muscle training and group exercises over a maximum of 8 sessions of 90 minutes; and pain management (n=69) which consisted of a combination of structured back pain education with group general strengthening, stretching and light aerobic exercises. A CBT approach was used. The programme consisted of a maximum of 8 sessions of 90 minutes each. For full details on the clinical results, please see section 9.4.1.</p><p>The number of QALYs gained over 18 months was estimated using EQ-5D. The costing perspective was that of the UK health service. Direct medical costs were measured by collecting public health service (NHS) utilisation data for the previous 6 months to each assessment from physiotherapy notes and from participants using the interview-based questionnaire Client Services Receipt Inventory. Units costs (£) for 2003 to 2004 were obtained from the Personal Social Services Research Unit Database, NHS reference costs, and British National Formulary. Costs and outcomes occurring during the 12- to 18-month period were each discounted at 3.5%, the current recommended rate for public sector projects.</p><p>Sensitivity analyses were conducted to investigate effects of missing data and high-cost outliers.</p></div><div id="ch10.s15"><h4>Results (base case)</h4><p>The mean costs (Standard Deviation) of the three therapies were £474(840) for individual physiotherapy, £379(1040) for spinal stabilization and £165 (202) for pain management. Mean (Standard Deviation) QALY gains after 18 months were 0.99(0.27) for individual physiotherapy, 0.90(0.37) for spinal stabilization and 1.00 (0.28) for pain management. Overall, pain management is less costly and marginally more effective than the other interventions. Relative to spinal stabilisation, individual physiotherapy is marginally more effective with a mean incremental cost effectiveness ratio of £1055.</p><p>The cost-effectiveness acceptability curves show the probability of cost-effectiveness for the three interventions for a range of prices a health commissioner might be prepared to pay per QALY. As pain management is marginally most effective and is associated with lowest healthcare costs, it is most likely to be cost-effective at all costs per QALY.</p></div><div id="ch10.s16"><h4>Sensitivity analysis</h4><p>The study reported on two sensitivity analyses. 1) The exclusion of three patients (two from spinal stabilisation and one from individual physiotherapy) who incurred unusually high costs because they received spinal fusion or decompression surgery. 2) The imputation of missing EQ-5D data and cost data for all patients with endpoint clinical data.</p><p>Sensitivity analysis showed that imputing missing data made little difference to the results. However, excluding the three patients who received spinal surgery markedly reduces the associated costs of the spinal stabilization arm to £187.54(198.65), increases the incremental cost-effectiveness ratio for individual physiotherapy relative to this (£3543), and the differences in total mean public health service costs across the three groups become significant (P =0.007).</p><p>In the base case analysis a physiotherapist-led pain management programme was marginally the most effective and was associated with lowest healthcare costs, and is therefore most likely to be cost-effective at all costs per QALY. Probabilistic sensitivity analyses showed that at a ceiling of £20,000 per QALY the probability that a pain management programme is cost effective is approximately 70%. Sensitivity analysis which imputes missing values or excludes statistical outliers does not alter this result.</p></div><div id="ch10.s17"><h4>Discussion</h4><p>After careful discussion of the uncertainty inherent in the underlying trials, the GDG decided that the presented evidence on the low intensity CPP was not sufficient to conclude that low intensity CPP would be clinically and cost-effective in an NHS context.</p><p>With respect to intensive CPP interventions, there were no economic papers found to inform the GDG on cost effectiveness of such an intervention. The GDG asked whether there would be some evidence when using a broader pain management population. A search did not find suitable papers to inform on the cost effectiveness using this population</p><p>Due to the lack of evidence for a significant benefit of intensive CPP programmes from high-quality studies, a recommendation for routine use in the NHS has to be further tested. As it remained uncertain whether such high intensity CPPs were likely to be a cost-effective use of NHS resources, further modelling was done.</p></div><div id="ch10.s18"><h4>10.5.2.1. Modelling the Cost-effectiveness of intensive combined psychological and physical (CPP) programmes</h4><p>The question addressed by this model concerns referral to a combined programme involving psychological and physical interventions for patients with high levels of distress, judged to be at risk of developing chronic pain. There is no published cost-effectiveness evidence for these intensive CPP programmes, and the clinical evidence is limited (see 9.4.1) It was not possible to build a cost-effectiveness model based on these studies identified in the guideline review.</p><p>A decision tree model was built, based on the results from the Haldorsen study and other data and assumptions (see Appendix E, sections 1.1.1–1.1.2, p2–13), to estimate the relative costs and health effects (QALYs) for alternative treatment strategies. Probabilistic and a number of univariate sensitivity analyses were carried out in order to quantify and estimate the uncertainty of the results. Results from the economic modelling showed that for those people with poor prognosis where a monotherapy has failed, a more intensive CPP yields more QALYs and would be most cost effective compared to no CPP.</p><p>The full write up of the model can be found in Appendix E.</p></div></div><div id="ch10.s19"><h3>10.5.3. Evidence statements for combined physical and psychological interventions</h3><div id="ch10.t3" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK11705/table/ch10.t3/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__ch10.t3_lrgtbl__"><table><thead><tr><th id="hd_h_ch10.t3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Evidence statements</th><th id="hd_h_ch10.t3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Evidence to recommendations</th></tr></thead><tbody><tr><td headers="hd_h_ch10.t3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CPP Low intensity:
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<dl class="temp-labeled-list"><dt>10.5.3.1.</dt><dd><p class="no_top_margin">One RCT compared a pain management programme to individual physiotherapy and spinal stabilisation. After 18 months no significant differences between groups was observed. (1-) (<a href="/books/n/nicecg88/ch12/#ch12.r34" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r34/" data-bk-pop-others="" class="bk_pop">Critchley, D. J., Ratcliffe, J., Noonan, S. et al, 2007</a>)</p></dd><dt>10.5.3.2.</dt><dd><p class="no_top_margin">One RCT compared a Back School to usual care and reports significant difference between back school and controls (although the results of that analysis are not presented). (1-) (<a href="/books/n/nicecg88/ch12/#ch12.r128" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r128/" data-bk-pop-others="" class="bk_pop">Tavafian, Sedigheh Sadat, Jamshidi, Ahmadreza, Mohammad, Kazem et al, 2007</a>)</p></dd></dl></td><td headers="hd_h_ch10.t3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">GDG made a distinction between lower intensity combined physical and psychological therapies (CPP) and higher intensity CPP; Studies were classified as high intensity when the intervention was over at least one full day or at least five sessions a week over at least three weeks.<br />CPP Low intensity:<br />One well conducted study shows benefit but in non-UK all female population.<br />One UK study was identified that had less intensive interventions for a less disabled group and demonstrated cost effectiveness (8 sessions of 90 mins). However, the study had a high attrition rate and showed no significant difference between groups. GDG considered that the evidence available was not sufficient to make a recommendation for low intensity CPP.</td></tr><tr><td headers="hd_h_ch10.t3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CPP High intensity:
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<dl class="temp-labeled-list"><dt>10.5.3.3.</dt><dd><p class="no_top_margin">Four RCT’s compared Functional Restoration programmes to other interventions/usual care. Three of these RCT found significant improvements in pain and disability for patients in the FR group compared to less intensive interventions(1-) (<a href="/books/n/nicecg88/ch12/#ch12.r2" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r2/" data-bk-pop-others="" class="bk_pop">Alaranta, H., Rytokoski, U., Rissanen, A. et al, 1994</a>); (1-)(<a href="/books/n/nicecg88/ch12/#ch12.r12" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r12/" data-bk-pop-others="" class="bk_pop">Bendix, A. F., Bendix, T., Ostenfeld, S. et al, 1995</a>);(1-)(<a href="/books/n/nicecg88/ch12/#ch12.r11" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r11/" data-bk-pop-others="" class="bk_pop">Bendix, A. F., Bendix, T., Lund, C. et al, 1997</a>)(1-);(<a href="/books/n/nicecg88/ch12/#ch12.r10" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r10/" data-bk-pop-others="" class="bk_pop">Bendix, A. F., Bendix, T., Labriola, M. et al, 1998</a>);(1-)(<a href="/books/n/nicecg88/ch12/#ch12.r9" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r9/" data-bk-pop-others="" class="bk_pop">Bendix, A. E., Bendix, T., Haestrup, C. et al, 1998</a>) or usual care (1-) (<a href="/books/n/nicecg88/ch12/#ch12.r32" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r32/" data-bk-pop-others="" class="bk_pop">Corey, D. T., Koepfler, L. E., Etlin, D. et al, 1996</a>).</p></dd><dt>10.5.3.4.</dt><dd><p class="no_top_margin">No significant difference in pain or function was observed between a FR programme and physical training (1-) (<a href="/books/n/nicecg88/ch12/#ch12.r14" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r14/" data-bk-pop-others="" class="bk_pop">Bendix, T., Bendix, A., Labriola, M. et al, 2000</a>)</p></dd><dt>10.5.3.5.</dt><dd><p class="no_top_margin">Three RCTs compared multidisciplinary programmes to physiotherapy or no treatment. One study showed significantly better pain and function scores in the multidisciplinary programme (1-) (<a href="/books/n/nicecg88/ch12/#ch12.r13" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r13/" data-bk-pop-others="" class="bk_pop">Bendix, A. F., Bendix, T., Vaegter, K. et al, 1996</a>) ;(1-)(<a href="/books/n/nicecg88/ch12/#ch12.r10" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r10/" data-bk-pop-others="" class="bk_pop">Bendix, A. F., Bendix, T., Labriola, M. et al, 1998</a>).. One found no significant differences between or groups for pain, disability depression (1+) (<a href="/books/n/nicecg88/ch12/#ch12.r81" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r81/" data-bk-pop-others="" class="bk_pop">Kääpä, Eeva Helena, Frantsi, Kirsi, Sarna, Seppo et al, 2006</a>),, and the third did not conduct statistical analysis on between-group differences(1-) (<a href="/books/n/nicecg88/ch12/#ch12.r85" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r85/" data-bk-pop-others="" class="bk_pop">Keller, S., Ehrhardt, Schmelzer S., Herda, C. et al, 1997</a>)</p></dd><dt>10.5.3.6.</dt><dd><p class="no_top_margin">One RCT compared an exercise + motivational programme to exercise-only. At 12 months follow-up pain and function were statistically significantly improved in the intervention group. After 5years follow-up only pain remained statistically significantly improved in the intervention group compared to the exercise-only group.(1-) (<a href="/books/n/nicecg88/ch12/#ch12.r47" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r47/" data-bk-pop-others="" class="bk_pop">Friedrich, M., Gittler, G., Arendasy, M. et al, 2005</a>; <a href="/books/n/nicecg88/ch12/#ch12.r48" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r48/" data-bk-pop-others="" class="bk_pop">Friedrich, M., Gittler, G., Halberstadt, Y. et al, 1998</a>)</p></dd><dt>10.5.3.7.</dt><dd><p class="no_top_margin">One well conducted RCT compared a combination of physical training and graded activity with problem solving intervention to the individual treatments. No significant difference was observed between the groups at 12 months follow-up.(1+) (<a href="/books/n/nicecg88/ch12/#ch12.r122" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r122/" data-bk-pop-others="" class="bk_pop">Smeets, Rob. J. E. M., Vlaeyen, Johan. W. S., Hidding, Alita. et al, 2008</a>)</p></dd><dt>10.5.3.8.</dt><dd><p class="no_top_margin">One economic evaluation found in the base-case analysis a physiotherapist-led pain management programme is associated with lowest healthcare costs and likely to be most cost effective at all costs per QALY. Sensitivity analysis found that at a ceiling of £20k per QALY the probability that a pain management programme is cost effective is 70% (<a href="/books/n/nicecg88/ch12/#ch12.r34" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r34/" data-bk-pop-others="" class="bk_pop">Critchley, D. J., Ratcliffe, J., Noonan, S. et al, 2007</a>)</p></dd></dl></td><td headers="hd_h_ch10.t3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CPP High intensity:<br />Population in the studies for more intensive interventions were more severely disabled by their condition and more were off work.<br />Programmes within the intensive studies were usually for more than 40 hours. The GDG considered what was the appropriate exposure to the intervention in these programmes. The best evidence for effectiveness is for programmes of >100 hours of exposure (<a href="/books/n/nicecg88/ch12/#ch12.r58" data-bk-pop-rid="/books/n/nicecg88/ch12/def-item/ch12.r58/" data-bk-pop-others="" class="bk_pop">Guzmán, J., Esmail, R., Karjalainen, K. et al, 2001</a>). The GDG therefore recommended that such programmes should have at least 100 hours of exposure to the intervention spread over up to three months. This review had been excluded for this question because it contained some non-relevant studies. The relevant studies within the review were extracted and presented separately.<br />The format of the interventions delivered varied widely between trials and there is insufficient evidence to select one format over another but it is possible to make a statement regarding the total number of sessions delivered.<br />Following comments received from stakeholders the content of the programmes was considered again and the GDG agreed that all the studies included a CBT approach and exercise, and many included some aspect of goal setting/problem solving and this should be included as a recommendation.<br />The GDG discussed the methodology used and reliability of those studies showing a significant benefit in outcomes compared with the two studies achieving a higher grading methodologically which failed to show a benefit.<br />The GDG considered that the high quality study from a previous question on psychosocial screening which found that screening for prognosis aids in identifying who may gain greater benefit from intensive or less intensive treatments may be relevant to this question (Haldorsen). However the outcome reported was return to work.<br />No economic evidence was found for the more intensive programmes. An estimate of the cost effectiveness from the clinical studies was possible from only one study that had used an outcome measure that could be used to estimate QALYs (Smeets). This showed the QALY gain with CPP would be lower than the control.<br />The GDG asked the methods team to go back to the Haldorsen study included for the psychosocial screening question to see if data could be used to inform their decision.<br />The economic model presented to the GDG was based on data taken from the Haldorsen paper. The outcome measure of return to work was interpreted to mean recovery and this was converted into a suitable QALY. The prognostic indicators from the trial were used to build a decision tree which compared six strategies: 1) no CPP, 2) CPP immediately for people with poor prognosis (p/p) only, 3) CPP after a monotherapy (LMT), 4) CPP after LMT for p/p only, 5) CPP first line for p/p and after LMT for people with a good or medium (g/m) prognosis who don’t respond and 6) CPP for all<br />At base case, comparator 4 yields more QALYs and would be most cost effective compared to no CPP. This strategy would be to start with a light programme and then onto a more intensive programme for those identified as having a poor prognosis and who have not benefited from less intensive interventions.<br />The GDG agreed that from the limited clinical evidence and the economic model presented CPP should be made available to those who continue to report high levels of disability and/or psychological distress after one or more previous treatments in addition to medical care and information.</td></tr></tbody></table></div></div></div></div><div id="bk_toc_contnr"></div></div></div>
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<div class="post-content"><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> © 2009, Royal College of General Practitioners.<p class="small">All rights reserved. No part of this publication may be reproduced in any form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this publication) without the written permission of the copyright owner. Applications for the copyright owner’s written permission to reproduce any part of this publication should be addressed to the publisher.</p></div><div class="small"><span class="label">Bookshelf ID: NBK11705</span></div><div style="margin-top:2em" class="bk_noprnt"><a class="bk_cntns" href="/books/n/nicecg88/">Contents</a><div class="pagination bk_noprnt"><a class="active page_link prev" href="/books/n/nicecg88/ch9/" title="Previous page in this title">< Prev</a><a class="active page_link next" href="/books/n/nicecg88/ch11/" title="Next page in this title">Next ></a></div></div></div></div>
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<div xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Views</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="PDF_download" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="/books/NBK11705/?report=reader">PubReader</a></li><li><a href="/books/NBK11705/?report=printable">Print View</a></li><li><a data-jig="ncbidialog" href="#_ncbi_dlg_citbx_NBK11705" data-jigconfig="width:400,modal:true">Cite this Page</a><div id="_ncbi_dlg_citbx_NBK11705" style="display:none" title="Cite this Page"><div class="bk_tt">National Collaborating Centre for Primary Care (UK). Low Back Pain: Early Management of Persistent Non-specific Low Back Pain [Internet]. London: Royal College of General Practitioners (UK); 2009 May. (NICE Clinical Guidelines, No. 88.) 10, Psychological interventions and mixed packages of care (combined physical and psychological interventions)<span class="bk_cite_avail"></span></div></div></li><li><a href="/books/n/nicecg88/pdf/">PDF version of this title</a> (980K)</li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>In this Page</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="page-toc" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="#ch10.s1" ref="log$=inpage&link_id=inpage">Introduction</a></li><li><a href="#ch10.s2" ref="log$=inpage&link_id=inpage">Recommendations for combined physical and psychological treatment programme</a></li><li><a href="#ch10.s3" ref="log$=inpage&link_id=inpage">Psychological Screening</a></li><li><a href="#ch10.s7" ref="log$=inpage&link_id=inpage">Psychological Interventions</a></li><li><a href="#ch10.s11" ref="log$=inpage&link_id=inpage">Combined Physical and Psychological Therapy</a></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Other titles in this collection</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="source-links" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="/books/n/nicecollect/">National Institute for Health and Clinical Excellence: Guidance</a></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Recent Activity</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="recent_activity" id="Shutter"></a></div><div class="portlet_content"><div xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" id="HTDisplay" class=""><div class="action"><a href="javascript:historyDisplayState('ClearHT')">Clear</a><a href="javascript:historyDisplayState('HTOff')" class="HTOn">Turn Off</a><a href="javascript:historyDisplayState('HTOn')" class="HTOff">Turn On</a></div><ul id="activity"><li class="ra_rcd ralinkpopper two_line"><a class="htb ralinkpopperctrl" ref="log$=activity&linkpos=1" href="/portal/utils/pageresolver.fcgi?recordid=67d78794cde49f3df744ce26">Psychological interventions and mixed packages of care (combined physical and ps...</a><div class="ralinkpop offscreen_noflow">Psychological interventions and mixed packages of care (combined physical and psychological interventions) - Low Back Pain<div class="brieflinkpopdesc"></div></div><div class="tertiary"></div></li><li class="ra_rcd ralinkpopper two_line"><a class="htb ralinkpopperctrl" ref="log$=activity&linkpos=2" href="/portal/utils/pageresolver.fcgi?recordid=67d7879367c23b31e012f0f4">Invasive Procedures - Low Back Pain</a><div class="ralinkpop offscreen_noflow">Invasive Procedures - Low Back Pain<div class="brieflinkpopdesc"></div></div><div class="tertiary"></div></li><li class="ra_rcd ralinkpopper two_line"><a class="htb ralinkpopperctrl" ref="log$=activity&linkpos=3" href="/portal/utils/pageresolver.fcgi?recordid=67d7879284f3725e598d4767">Other non-pharmacological therapies - Low Back Pain</a><div class="ralinkpop offscreen_noflow">Other non-pharmacological therapies - Low Back Pain<div class="brieflinkpopdesc"></div></div><div class="tertiary"></div></li><li class="ra_rcd ralinkpopper two_line"><a class="htb ralinkpopperctrl" ref="log$=activity&linkpos=4" href="/portal/utils/pageresolver.fcgi?recordid=67d787912f30673f7b613a7a">Manual therapy - Low Back Pain</a><div class="ralinkpop offscreen_noflow">Manual therapy - Low Back Pain<div class="brieflinkpopdesc"></div></div><div class="tertiary"></div></li><li class="ra_rcd ralinkpopper two_line"><a class="htb ralinkpopperctrl" ref="log$=activity&linkpos=5" href="/portal/utils/pageresolver.fcgi?recordid=67d7879067c23b31e012d300">Physical activity and exercise - Low Back Pain</a><div class="ralinkpop offscreen_noflow">Physical activity and exercise - Low Back Pain<div class="brieflinkpopdesc"></div></div><div class="tertiary"></div></li></ul><p class="HTOn">Your browsing activity is empty.</p><p class="HTOff">Activity recording is turned off.</p><p id="turnOn" class="HTOff"><a href="javascript:historyDisplayState('HTOn')">Turn recording back on</a></p><a class="seemore" href="/sites/myncbi/recentactivity">See more...</a></div></div></div>
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<a href="https://www.nlm.nih.gov/accessibility.html" class="text-white">Accessibility</a><br />
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<a href="https://www.nlm.nih.gov/careers/careers.html" class="text-white">Careers</a></p>
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<nav class="bottom-links">
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<ul class="mt-3">
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<li>
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<a class="text-white" href="//www.nlm.nih.gov/">NLM</a>
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</li>
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<li>
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<a class="text-white" href="https://www.nih.gov/">NIH</a>
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</li>
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<li>
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<a class="text-white" href="https://www.hhs.gov/">HHS</a>
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<li>
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<a class="text-white" href="https://www.usa.gov/">USA.gov</a>
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<script type="text/javascript" src="/portal/portal3rc.fcgi/static/js/hfjs2.js"> </script>
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<noscript><img alt="statistics" src="/stat?jsdisabled=true&ncbi_db=books&ncbi_pdid=book-part&ncbi_acc=NBK11705&ncbi_domain=nicecg88&ncbi_report=record&ncbi_type=fulltext&ncbi_objectid=&ncbi_pcid=/NBK11705/&ncbi_pagename=Psychological interventions and mixed packages of care (combined physical and psychological interventions) - Low Back Pain - NCBI Bookshelf&ncbi_bookparttype=chapter&ncbi_app=bookshelf" /></noscript>
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