Physiotherapy informed by Acceptance and Commitment Therapy (PACT): Protocol for a randomised controlled trial of PACT versus usual physiotherapy care for adults with chronic low back pain

BMJ Open

Volumn 6, Issue 6, 2016, Pages

  Godfrey, Emma ^a   Galea Holmes, Melissa ^a   Wileman, Vari ^a   Mccracken, Lance ^a   Norton, Sam ^a   Moss Morris, Rona ^a   Pallet, John ^a   Sanders, Duncan ^b   Barcellona, Massimo ^c   Critchley, Duncan ^d  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b ROYAL NORTH SHORE HOSPITAL   (Australia)

^c KING'S COLLEGE HOSPITAL NHS FOUNDATION TRUST   (United Kingdom)

^d KING'S COLLEGE LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACCEPTANCE AND COMMITMENT THERAPY; ADULT; ANALGESIA; ARTICLE; COGNITIVE BEHAVIORAL THERAPY; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; EXERCISE; FOLLOW UP; FUNCTIONAL STATUS; HEALTH ECONOMICS; HEALTH SERVICE; HUMAN; LIFE SATISFACTION; LOW BACK PAIN; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NATIONAL HEALTH SERVICE; PAIN ASSESSMENT; PATIENT COMPLIANCE; PATIENT HEALTH QUESTIONNAIRE 9; PATIENT SAFETY; PHASE 2 CLINICAL TRIAL; PHYSIOTHERAPIST; PHYSIOTHERAPY; PHYSIOTHERAPY INFORMED BY ACCEPTANCE AND COMMITMENT THERAPY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; ROLAND MORRIS DISABILITY QUESTIONNAIRE; SOCIAL ADAPTATION; ADOLESCENT; AGED; CHRONIC DISEASE; CLINICAL TRIAL; DISABILITY; FEMALE; KINESIOTHERAPY; MALE; METHODOLOGY; MIDDLE AGED; PAIN MEASUREMENT; PROCEDURES; QUESTIONNAIRE; TREATMENT OUTCOME; UNITED KINGDOM; YOUNG ADULT;

ACCEPTANCE AND COMMITMENT THERAPY; ADOLESCENT; ADULT; AGED; CHRONIC DISEASE; DISABILITY EVALUATION; EXERCISE THERAPY; FEMALE; HUMANS; LOW BACK PAIN; MALE; MIDDLE AGED; PAIN MEASUREMENT; RESEARCH DESIGN; SURVEYS AND QUESTIONNAIRES; TREATMENT OUTCOME; UNITED KINGDOM; YOUNG ADULT;

EID: 84974589139     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2016-011548     Document Type: Article

References (57)

1. Hoy D, March L, Brooks P, et al. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis 2014; 73: 968-74.
2. Murray CJL, Vos T, Lozano R, et al. Disability-Adjusted life years (DALYs) for 291 diseases, and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2197-223.
3. Dagenais S, Caro J, Haldeman S A systematic review of low back pain cost of illness studies in the United States, and internationally. Spine J 2008; 8: 8-20.
4. Department of Health. Departmental Report 2009. London: DoH, 2009.
5. Maniadakis N, Gray A. The economic burden of back pain in the UK. Pain 2000; 84: 95-103.
6. National Institute for Health, and Clinical Excellence. Low back pain: early management or persistent non-specific low back pain. CG88. London: National Institute for Health, and Clinical Excellence, 2009. http://guidance.nice.org.uk/CG88/Guidance/pdf/English
7. Brox JI, Storheim K, Grotle M, et al. Systematic review of back schools, brief education, and fear-Avoidance training for chronic low back pain. Spine J 2008; 8: 948-58.
8. 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.
9. Artus M, van der Windt DA, Jordan KP, et al. Low back pain symptoms show a similar pattern of improvement following a wide range of primary care treatments: a systematic review of randomized clinical trials. Rheumatology (Oxford) 2010; 49: 2346-56.
10. van Middelkoop M, Rubinstein SM, Verhagen AP, et al. Exercise therapy for chronic nonspecific low-back pain. Best Pract Res Clin Rheumatol 2010; 24: 193-204.
11. Foster NE, Delitto A. Embedding psychosocial perspectives within clinical management of low back pain: integration of psychosocially informed management principles into physical therapist practice-challenges, and opportunities. Phys Ther 2011; 91: 790-803.
12. Gatchel RJ, Peng YB, Peters ML, et al. The biopsychosocial approach to chronic pain: scientific advances, and future directions. Psychol Bull 2007; 133: 581.
13. Eccleston C, Williams A, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev 2009; 2: CD007407.
14. Hoffman BM, Papas RK, Chatkoff DK, et al. Meta-Analysis of psychological interventions for chronic low back pain. Health Psychol 2007; 26: 1-9.
15. Scascighini L, Toma V, Dober-Spielmann S, et al. Multidisciplinary treatment for chronic pain: a systematic review of interventions, and outcomes. Rheumatology (Oxford) 2008; 47: 670-8.
16. Williams AC, Eccleston C, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev 2012; 11: CD007407.
17. Donaghy M, Nicol M, Davidson KM. Cognitive behavioural interventions in physiotherapy, and occupational therapy. Edinburgh: Elsevier/Butterworth-Heinemann, 2008.
18. Lamb SE, Hansen Z, Lall R, et al., Back Skills Training Trial investigators. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial, and cost-effectiveness analysis. Lancet 2010; 375: 916-23.
19. Brunner E, De Herdt A, Minguet P, et al. Can cognitive behavioural therapy based strategies be integrated into physiotherapy for the prevention of chronic low back pain? A systematic review. Disabil Rehabil 2013; 35: 1-10.
20. Alexanders J, Anderson A, Henderson S. Musculoskeletal physiotherapists? use of psychological interventions: a systematic review of therapists? perceptions, and practice. Physiotherapy 2015; 101: 95-102.
21. Hayes SC, Strosahl K, Wilson KG. Acceptance, and commitment therapy: an experimental approach to behaviour change. New York: Guilford Press, 1999.
22. McCracken L, Morley S. The psychological flexibility model: a basis for integration, and progress in psychological approaches to chronic pain management. J Pain 2014; 15(3): 221-34.
23. Vowles KE, Thompson M. Acceptance, and commitment therapy for chronic pain, mindfulness, and acceptance in behavioral medicine: current theory, and practice. Oakland, CA: New Harbinger 2011: 31-60.
24. Hann KEJ, McCracken LM A systematic review of randomized controlled trials of acceptance, and commitment therapy for adults with chronic pain: outcome domains, design quality, and efficacy. J Context Behav Sci 2014; 3: 217-27.
25. Veehof MM, Oskam MJ, Schreurs KM, et al. Acceptance-based interventions for the treatment of chronic pain: a systematic review, and meta-Analysis. Pain 2011; 152: 533-42.
26. Öst L-G. The efficacy of Acceptance, and Commitment Therapy: an updated systematic review, and meta-Analysis. Behav Res Ther 2014; 61: 105-21.
27. Vowles KE, McCracken LM, O?Brien JZ. Acceptance, and values-based action in chronic pain: a three-year follow-up analysis of treatment effectiveness, and process. Behav Res Ther 2011; 49: 748-55.
28. Pincus T, Anwar S, McCracken LM, et al. Delivering an Optimised Behavioural Intervention (OBI) to people with low back pain with high psychological risk; results, and lessons learnt from a feasibility randomized controlled trial of Contextual Cognitive Behavioural Therapy (CCBT) vs. BMC Musculoskelet Disord 2015; 16: 147.
29. Barker E, McCracken LM. From traditional cognitive-behavioural therapy to acceptance, and commitment therapy for chronic pain: a mixed-methods study of staff experiences of change. Br J Pain 2014; 8: 98-106.
30. Critchley DJ, McCracken L, Talewar R, et al. Physiotherapy informed by acceptance, and commitment therapy for persistent low back pain: the PACT study. Physiotherapy 2015; 101: E277.
31. Frost H, Lamb S, Doll H, et al. Randomised controlled trial of physiotherapy compared with advice for low back pain. BMJ 2004; 329: 708.
32. Hay E, Mullins R, Lewis M, et al. Comparison of physical treatments versus a brief pain-management programme for back pain in primary care: a randomised clinical trial in physiotherapy practice. Lancet 2005; 365: 2024-30.
33. Plumb JC, Vilardaga R. Assessing treatment integrity in Acceptance, and Commitment Therapy: strategies, and suggestion. Int J Behav Consultation Ther 2010; 6: 264-95.
34. Godfrey E, Chalder T, Ridsdale L, et al. Investigating the active ingredients of cognitive behaviour therapy, and counselling for patients with chronic fatigue in primary care: developing a new process measure to assess treatment fidelity, and predict outcome. Br J Clin Psychol 2007; 46(Pt 3): 253-72.
35. Boutron I, Moher D, Altman DG, et al. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation, and elaboration. Ann Intern Med 2008; 148: 295-309.
36. Herdman M, Gudex C, Lloyd A, et al. Development, and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011; 20: 1727-36.
37. Ware J, Kosinski M, Keller S A 12-Item Short-Form Health Survey: construction of scales, and preliminary tests of reliability, and validity. Medical Care 1996; 34: 220-3.
38. Roland M, Morris R A study of the natural history of back pain. Part I: development of a reliable, and sensitive measure of disability in low-back pain. Spine 1983; 8: 141-4.
39. Fish RA, McGuire B, Hogan M, et al. Research papers: validation of the Chronic Pain Acceptance Questionnaire (CPAQ) in an internet sample, and development, and preliminary validation of the CPAQ-8. Pain 2010; 149: 435-43.
40. McCracken LM, Chilcot J, Norton S. Further development in the assessment of psychological flexibility: a shortened Committed Action Questionnaire (CAQ-8). Eur J Pain 2015; 19: 677-85.
41. Stratford P, Gill C, Westaway M, et al. Assessing disability, and change on individual patients: a report of a patient specific measure. Physiotherapy Canada 1995; 47: 258-63.
42. Mundt JC, Marks IM, Shear MK, et al. The work, and social adjustment scale: a simple measure of impairment in functioning. Br J Psychiatry 2002; 180: 461-4.
43. Nicholas MK. The pain self-efficacy questionnaire: taking pain into account. Eur J Pain 2007; 11: 153-63.
44. Spitzer RL, Kroenke K, Williams JB, et al A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 2006; 166: 1092-7.
45. Kroenke K, Spitzer RL, Williams JBW. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001; 16: 606-13.
46. Bombardier C. Outcome assessments in the evaluation of treatment of spinal disorders-Summary, and general recommendations. Spine (Phila Pa 1976) 2000; 25: 3100-3.
47. Borkovec TD, Nau SD. Credibility of analogue therapy rationales. J Behav Ther Exp Psychiatry 1972; 3: 257-60.
48. Lamb SE, Lall R, Hansen Z, et al A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The Back Skills Training (BeST) trial. Health Technol Assess 2010; 14: 1-iv.
49. Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005; 113: 9-19.
50. Roland M, Fairbank J. The Roland-Morris Disability Questionnaire, and the Oswestry Disability Questionnaire. Spine 2000; 25: 3115-24.
51. National Institute for Health, and Clinical Excellence. Guide to the methods of technology appraisal. London: National Institute for Health, and Clinical Excellence, 2013.
52. Manca A, Kumar K, Taylor RS, et al. Quality of life, resource consumption, and costs of spinal cord stimulation versus conventional medical management in neuropathic pain patients with failed back surgery syndrome (PROCESS trial). Eur J Pain 2008; 12: 1047-58.
53. Henchoz Y, Pinget C, Wasserfallen J-B, et al. Cost-utility analysis of a three-month exercise programme vs. routine usual care following multidisciplinary rehabilitation for chronic low back pain. J Rehab Med 2010; 42: 846-52.
54. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006; 3: 77-101.
55. Ritchie J, Lewis JE. Qualitative research practice: a guide for social science students, and researchers. London: SAGE, 2003.
56. Critchley DJ, Ratcliffe J, Noonan S, et al. Effectiveness, and cost-effectiveness of three types of physiotherapy used to reduce chronic low back pain disability: a pragmatic randomized trial with economic evaluation. Spine 2007; 32: 1474-81.
57. MacKinnon DP. Introduction to Statistical Mediation Analysis. New York, NY: Taylor & Francis Group, 2008.