Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT)

Mary O'Keeffe, Peter O'Sullivan, Helen Purtill, Norma Bargary, Kieran O'Sullivan, Mary O'Keeffe, Peter O'Sullivan, Helen Purtill, Norma Bargary, Kieran O'Sullivan

Abstract

Background: One-size-fits-all interventions reduce chronic low back pain (CLBP) a small amount. An individualised intervention called cognitive functional therapy (CFT) was superior for CLBP compared with manual therapy and exercise in one randomised controlled trial (RCT). However, systematic reviews show group interventions are as effective as one-to-one interventions for musculoskeletal pain. This RCT investigated whether a physiotherapist-delivered individualised intervention (CFT) was more effective than physiotherapist-delivered group-based exercise and education for individuals with CLBP.

Methods: 206 adults with CLBP were randomised to either CFT (n=106) or group-based exercise and education (n=100). The length of the CFT intervention varied according to the clinical progression of participants (mean=5 treatments). The group intervention consisted of up to 6 classes (mean=4 classes) over 6-8 weeks. Primary outcomes were disability and pain intensity in the past week at 6 months and 12months postrandomisation. Analysis was by intention-to-treat using linear mixed models.

Results: CFT reduced disability more than the group intervention at 6 months (mean difference, 8.65; 95% CI 3.66 to 13.64; p=0.001), and at 12 months (mean difference, 7.02; 95% CI 2.24 to 11.80; p=0.004). There were no between-group differences observed in pain intensity at 6 months (mean difference, 0.76; 95% CI -0.02 to 1.54; p=0.056) or 12 months (mean difference, 0.65; 95% CI -0.20 to 1.50; p=0.134).

Conclusion: CFT reduced disability, but not pain, at 6 and 12 months compared with the group-based exercise and education intervention. Future research should examine whether the greater reduction in disability achieved by CFT renders worthwhile differences for health systems and patients.

Trial registration number: ClinicalTrials.gov registry (NCT02145728).

Keywords: effectiveness; lower back; physiotherapy; randomised controlled trial.

Conflict of interest statement

Competing interests: MO received payments in 2016 for providing a professional development workshop and lecture for clinicians in the individualised multidimensional intervention (CFT) examined in this trial. KO and PO receive payments for CFT workshops and lectures. MO, PO and KO have written editorials and viewpoints which encourage the use of CFT, or its principles, in clinical practice.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
CONSORT flow diagram. CFT, cognitive functional therapy; CONSORT, Consolidated Standards of Reporting Trials
Figure 2
Figure 2
Mean disability for CFT (individualised) versus group. *Data are adjusted means from the linear mixed-effects models. Error bars show standard errors (SE).
Figure 3
Figure 3
Mean pain intensity for CFT (individualised) versus group. *Data are adjusted means from the linear mixed-effects models. Error bars show standard errors (SE).

References

    1. Maher C, Underwood M, Buchbinder R. Non-specific low back pain. The Lancet 2017;389:736–47. 10.1016/S0140-6736(16)30970-9
    1. Hartvigsen J, Hancock MJ, Kongsted A, et al. . What low back pain is and why we need to pay attention. The Lancet 2018;391:2356–67. 10.1016/S0140-6736(18)30480-X
    1. Foster NE, Anema JR, Cherkin D, et al. . Prevention and treatment of low back pain: evidence, challenges, and promising directions. The Lancet 2018;391:2368–83. 10.1016/S0140-6736(18)30489-6
    1. Buchbinder R, van Tulder M, Öberg B, et al. . Low back pain: a call for action. The Lancet 2018;391:2384–8. 10.1016/S0140-6736(18)30488-4
    1. National Institute for Health and Care Excellence (NICE) Low back pain and sciatica in over 16s: assessment and management, 2016. Available: [Accessed June 2018].
    1. Qaseem A, Wilt TJ, McLean RM, et al. . Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of physicians. Ann Intern Med 2017;166:514–30. 10.7326/M16-2367
    1. Stochkendahl MJ, Kjaer P, Hartvigsen J, et al. . National clinical guidelines for non-surgical treatment of patients with recent onset low back pain or lumbar radiculopathy. Eur Spine J 2018;27:60–75. 10.1007/s00586-017-5099-2
    1. O'Keeffe M, Hayes A, McCreesh K, et al. . Are group-based and individual physiotherapy exercise programmes equally effective for musculoskeletal conditions? A systematic review and meta-analysis. Br J Sports Med 2017;51:126–32. 10.1136/bjsports-2015-095410
    1. Hayden J, van Tulder MW, Malmivaara A, et al. . Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev 2005;35 10.1002/14651858.CD000335.pub2
    1. O'Keeffe M, Purtill H, Kennedy N, et al. . Comparative Effectiveness of Conservative Interventions for Nonspecific Chronic Spinal Pain: Physical, Behavioral/Psychologically Informed, or Combined? A Systematic Review and Meta-Analysis. J Pain 2016;17:755–74. 10.1016/j.jpain.2016.01.473
    1. Wegner I, Widyahening IS, van Tulder MW, et al. . Traction for low-back pain with or without sciatica. Cochrane Database Syst Rev 2013;18 10.1002/14651858.CD003010.pub5
    1. Henschke N, Ostelo RWJG, van Tulder MW, et al. . Behavioural treatment for chronic low-back pain. Cochrane Database Syst Rev 2010;49 10.1002/14651858.CD002014.pub3
    1. O'Sullivan P, Caneiro JP, O'Keeffe M, et al. . Unraveling the complexity of low back pain. J Orthop Sports Phys Ther 2016;46:932–7. 10.2519/jospt.2016.0609
    1. Jensen RK, Kent P, Hancock M. Do MRI findings identify patients with chronic low back pain and Modic changes who respond best to rest or exercise: a subgroup analysis of a randomised controlled trial. Chiropr Man Therap 2015;23 10.1186/s12998-015-0071-x
    1. Brinjikji W, Diehn FE, Jarvik JG, et al. . MRI findings of disc degeneration are more prevalent in adults with low back pain than in asymptomatic controls: a systematic review and meta-analysis. AJNR Am J Neuroradiol 2015;36:2394–9. 10.3174/ajnr.A4498
    1. Laird RA, Gilbert J, Kent P, et al. . Comparing lumbo-pelvic kinematics in people with and without back pain: a systematic review and meta-analysis. BMC Musculoskelet Disord 2014;15:229 10.1186/1471-2474-15-229
    1. Dankaerts W, O'Sullivan P, Burnett A, et al. . Differences in sitting postures are associated with nonspecific chronic low back pain disorders when patients are subclassified. Spine 2006;31:698–704. 10.1097/01.brs.0000202532.76925.d2
    1. Geisser ME, Haig AJ, Wallbom AS, et al. . Pain-related fear, lumbar flexion, and dynamic EMG among persons with chronic musculoskeletal low back pain. Clin J Pain 2004;20:61–9. 10.1097/00002508-200403000-00001
    1. Wertli MM, Rasmussen-Barr E, Weiser S, et al. . The role of fear avoidance beliefs as a prognostic factor for outcome in patients with nonspecific low back pain: a systematic review. Spine J 2014;14:e4:816–36. 10.1016/j.spinee.2013.09.036
    1. Darlow B, Fullen BM, Dean S, et al. . The association between health care professional attitudes and beliefs and the attitudes and beliefs, clinical management, and outcomes of patients with low back pain: a systematic review. Eur J Pain 2012;16:3–17. 10.1016/j.ejpain.2011.06.006
    1. Pinheiro MB, Ferreira ML, Refshauge K, et al. . Symptoms of depression as a prognostic factor for low back pain: a systematic review. Spine J 2016;16:105–16. 10.1016/j.spinee.2015.10.037
    1. Lee H, Mansell G, McAuley JH, et al. . Causal mechanisms in the clinical course and treatment of back pain. Best Pract Res Clin Rheumatol 2016;30:1074–83. 10.1016/j.berh.2017.04.001
    1. Stubbs B, Koyanagi A, Thompson T, et al. . The epidemiology of back pain and its relationship with depression, psychosis, anxiety, sleep disturbances, and stress sensitivity: data from 43 low- and middle-income countries. Gen Hosp Psychiatry 2016;43:63–70. 10.1016/j.genhosppsych.2016.09.008
    1. Alsaadi SM, McAuley JH, Hush JM, et al. . The bidirectional relationship between pain intensity and sleep disturbance/quality in patients with low back pain. Clin J Pain 2014;30:755–65. 10.1097/AJP.0000000000000055
    1. Rasmussen-Barr E, Grooten WJA, Hallqvist J, et al. . Are job strain and sleep disturbances prognostic factors for low-back pain?A cohort study of a general population of working age in Sweden. J Rehabil Med 2017;49:591–7. 10.2340/16501977-2249
    1. Hoogendoorn WE, van Poppel MN, Bongers PM, et al. . Systematic review of psychosocial factors at work and private life as risk factors for back pain. Spine 2000;25:2114–25. 10.1097/00007632-200008150-00017
    1. Bernal D, Campos-Serna J, Tobias A, et al. . Work-Related psychosocial risk factors and musculoskeletal disorders in hospital nurses and nursing aides: a systematic review and meta-analysis. Int J Nurs Stud 2015;52:635–48. 10.1016/j.ijnurstu.2014.11.003
    1. O'Sullivan K, O'Sullivan P, Vibe Fersum K, et al. . Better targeting care for individuals with low back pain: opportunities and obstacles. Br J Sports Med 2017;51:489–90. 10.1136/bjsports-2016-096612
    1. Hodges PW. Hybrid approach to treatment tailoring for low back pain: a proposed model of care. J Orthop Sports Phys Ther 2019;49:453–63. 10.2519/jospt.2019.8774
    1. O'Sullivan PB, Caneiro JP, O'Keeffe M, et al. . Cognitive functional therapy: an integrated behavioral approach for the targeted management of disabling low back pain. Phys Ther 2018;98:408–23. 10.1093/ptj/pzy022
    1. Vibe Fersum K, O'Sullivan P, Skouen JS, et al. . Efficacy of classification-based cognitive functional therapy in patients with non-specific chronic low back pain: a randomized controlled trial. Eur J Pain 2013;17:916–28. 10.1002/j.1532-2149.2012.00252.x
    1. Vibe Fersum K, Smith A, Kvåle A, et al. . Cognitive functional therapy in patients with non-specific chronic low back pain-a randomized controlled trial 3-year follow-up. Eur J Pain 2019;23:1416–24. 10.1002/ejp.1399
    1. O'Keeffe M, Purtill H, Kennedy N, et al. . Individualised cognitive functional therapy compared with a combined exercise and pain education class for patients with non-specific chronic low back pain: study protocol for a multicentre randomised controlled trial. BMJ Open 2015;5:e007156 10.1136/bmjopen-2014-007156
    1. Rannestad T, Skjeldestad FE. Socioeconomic conditions and number of pain sites in women. BMC Womens Health 2012;12:7 10.1186/1472-6874-12-7
    1. Fairbank JC, Pynsent PB. The Oswestry disability index. Spine 2000;25:2940–53. 10.1097/00007632-200011150-00017
    1. Jensen MP, Turner JA, Romano JM, et al. . Comparative reliability and validity of chronic pain intensity measures. Pain 1999;83:157–62. 10.1016/S0304-3959(99)00101-3
    1. Waddell G, Newton M, Henderson I, et al. . A Fear-Avoidance beliefs questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain 1993;52:157–68. 10.1016/0304-3959(93)90127-B
    1. Harland NJ, Georgieff K. Development of the coping strategies questionnaire 24, a clinically utilitarian version of the coping strategies questionnaire. Rehabil Psychol 2003;48:296–300. 10.1037/0090-5550.48.4.296
    1. Di Pietro F, Catley MJ, McAuley JH, et al. . Rasch analysis supports the use of the pain self-efficacy questionnaire. Phys Ther 2014;94:91–100. 10.2522/ptj.20130217
    1. Crawford JO. The Nordic musculoskeletal questionnaire. Occup Med 2007;57:300–1. 10.1093/occmed/kqm036
    1. Linton SJ, Nicholas M, MacDonald S. Development of a short form of the Örebro musculoskeletal pain screening questionnaire. Spine 2011;36:1891–5. 10.1097/BRS.0b013e3181f8f775
    1. Eriksen HR, Ihlebaek C, Ursin H. A scoring system for subjective health complaints (SHC). Scand J Public Health 1999;27:63–72. 10.1177/14034948990270010401
    1. Lovibond S, Lovibond P. Manual for the depression anxiety and stress scales (DASS) 1993;23.
    1. Marshall GN, Hays RD. The patient satisfaction questionnaire short-form (PSQ-18). CA: Rand Santa Monica; 1994.
    1. Cohen J. Pp. 79–81 in statistical power analysis for the behavioral sciences. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.
    1. Little RJ, Rubin DB. Statistical analysis with missing data. John Wiley & Sons, 2014.
    1. Mansournia MA, Altman DG. Inverse probability weighting. BMJ 2016;15 10.1136/bmj.i189
    1. Mansournia MA, Altman DG. Invited commentary: methodological issues in the design and analysis of randomised trials. Br J Sports Med 2018;52:553–5. 10.1136/bjsports-2017-098245
    1. Robins JM, Hernán MA, Brumback B. Marginal structural models and causal inference in epidemiology. Epidemiology 2000;11:550–60. 10.1097/00001648-200009000-00011
    1. Team RC R: a language and environment for statistical computing 2013.
    1. Avins A, Pressman A. (469) how Responder analyses can misinform in pain-related clinical trials. The Journal of Pain 2017;18 10.1016/j.jpain.2017.02.319
    1. Senn S. Mastering variation: variance components and personalised medicine. Stat Med 2016;35:966–77. 10.1002/sim.6739
    1. Hill JC, Whitehurst DGT, Lewis M, et al. . Comparison of stratified primary care management for low back pain with current best practice (start back): a randomised controlled trial. The Lancet 2011;378:1560–71. 10.1016/S0140-6736(11)60937-9
    1. Lamb SE, Hansen Z, Lall R, et al. . Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. The Lancet 2010;375:916–23. 10.1016/S0140-6736(09)62164-4
    1. Amundsen PA, Evans DW, Rajendran D, et al. . Inclusion and exclusion criteria used in non-specific low back pain trials: a review of randomised controlled trials published between 2006 and 2012. BMC Musculoskelet Disord 2018;19:113 10.1186/s12891-018-2034-6

Source: PubMed

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