Godfrey E1, Wileman V2, Galea Holmes M2, Norton S2, McCracken L2, Moss-Morris R2, Barcellona M3, Noonan S4, Critchley D5
1King's College London, Physiotherapy & Psychology, London, United Kingdom, 2King's College London, Psychology, London, United Kingdom, 3King's College London and King's College Hospital, Physiotherapy, London, United Kingdom, 4Guy's and St Thomas' Hospital and King's College London, Physiotherapy, London, United Kingdom, 5King's College London, Physiotherapy, London, United Kingdom
Background: Persistent low back pain (PLBP) is very common, increasing in prevalence and is the largest single cause of years lived with disability globally. Many patients receive physiotherapy that is moderately effective, however there is little consensus about the best methods to use. A more integrated biopsychosocial model of care, combining theory-based psychological methods with physiotherapy might be more effective. Acceptance and Commitment Therapy (ACT) is a promising treatment for chronic pain but has not been modified or tested for delivery by physiotherapists.
Purpose: This phase II randomised controlled trial (RCT) aimed to test the efficacy of physiotherapy informed by ACT (PACT) against usual care (UC) physiotherapy for patients with PLBP.
Methods: An assessor blind, multi-centre, two-armed RCT (registration: ISRCTN95392287) recruited adults with PLBP from secondary care physiotherapy clinics in three UK NHS hospitals. Inclusion criteria were: non-specific back pain ≥12 weeks´ duration, ≥3 points on Roland-Morris Disability Questionnaire (RMDQ). PACT consisted of two individual 60-minute, face-to-face sessions two weeks apart, plus one 20-minute telephone call one month later. UC was individual physiotherapy and/or back classes at the physiotherapist's discretion. PACT physiotherapists received 2 days training and monthly supervision. An independent randomisation centre used random block sizes stratified by recruiting centre to allocated participants. Primary outcome was functioning, assessed with RMDQ, at 3 months' follow-up. Secondary outcomes included: pain, mood, quality of life, satisfaction, acceptance, committed action and self-efficacy. Estimates of treatment effect at follow-up used linear-mixed models following the intention-to-treat principle.
Results: 248 (52%) of eligible participants (59% female, mean age=48) were recruited and 219 (88.3%) completed measures at 3 and/or 12 months' follow-up. 124 were randomised to PACT and 124 to UC between November 2014-March 2016. PACT participants reported significantly less disability at 3 months compared to those receiving UC physiotherapy (RMDQ mean difference -1·07, p=0·037, 95% CI-2·08 to -0·07, d=0·2). They also had a clinically important reduction of ≥3 points on the RMDQ and were more satisfied with their treatment. At 12 months, there were no significant differences between groups for RMDQ scores (mean difference -0.38, p=0.52) or for other outcomes. PACT was feasible and delivered with high (85%) treatment fidelity.
Conclusion(s): PACT participants reported significantly better functioning at the primary end point of 3 months' follow-up compared to UC physiotherapy but this advantage was not maintained at 12 months. PACT was an acceptable and credible treatment for patients with PLBP and may inform the delivery of physiotherapy services, with potential benefits for patients, health care providers and society.
Implications: This is the first trial to test the efficacy of ACT informed physiotherapy for patients with PLBP. Combining psychological methods with physiotherapy treatment has great potential, but it is not easy to implement. The model used in the PACT trial meant the intervention was delivered as planned and enabled physiotherapists to incorporate psychological techniques successfully. It now required further testing in a larger effectiveness trial.
Keywords: Persistent low back pain, Acceptance and Commitment Therapy, Randomised controlled trial
Funding acknowledgements: This is independent research funded by the NIHR under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-1112-29055).
Purpose: This phase II randomised controlled trial (RCT) aimed to test the efficacy of physiotherapy informed by ACT (PACT) against usual care (UC) physiotherapy for patients with PLBP.
Methods: An assessor blind, multi-centre, two-armed RCT (registration: ISRCTN95392287) recruited adults with PLBP from secondary care physiotherapy clinics in three UK NHS hospitals. Inclusion criteria were: non-specific back pain ≥12 weeks´ duration, ≥3 points on Roland-Morris Disability Questionnaire (RMDQ). PACT consisted of two individual 60-minute, face-to-face sessions two weeks apart, plus one 20-minute telephone call one month later. UC was individual physiotherapy and/or back classes at the physiotherapist's discretion. PACT physiotherapists received 2 days training and monthly supervision. An independent randomisation centre used random block sizes stratified by recruiting centre to allocated participants. Primary outcome was functioning, assessed with RMDQ, at 3 months' follow-up. Secondary outcomes included: pain, mood, quality of life, satisfaction, acceptance, committed action and self-efficacy. Estimates of treatment effect at follow-up used linear-mixed models following the intention-to-treat principle.
Results: 248 (52%) of eligible participants (59% female, mean age=48) were recruited and 219 (88.3%) completed measures at 3 and/or 12 months' follow-up. 124 were randomised to PACT and 124 to UC between November 2014-March 2016. PACT participants reported significantly less disability at 3 months compared to those receiving UC physiotherapy (RMDQ mean difference -1·07, p=0·037, 95% CI-2·08 to -0·07, d=0·2). They also had a clinically important reduction of ≥3 points on the RMDQ and were more satisfied with their treatment. At 12 months, there were no significant differences between groups for RMDQ scores (mean difference -0.38, p=0.52) or for other outcomes. PACT was feasible and delivered with high (85%) treatment fidelity.
Conclusion(s): PACT participants reported significantly better functioning at the primary end point of 3 months' follow-up compared to UC physiotherapy but this advantage was not maintained at 12 months. PACT was an acceptable and credible treatment for patients with PLBP and may inform the delivery of physiotherapy services, with potential benefits for patients, health care providers and society.
Implications: This is the first trial to test the efficacy of ACT informed physiotherapy for patients with PLBP. Combining psychological methods with physiotherapy treatment has great potential, but it is not easy to implement. The model used in the PACT trial meant the intervention was delivered as planned and enabled physiotherapists to incorporate psychological techniques successfully. It now required further testing in a larger effectiveness trial.
Keywords: Persistent low back pain, Acceptance and Commitment Therapy, Randomised controlled trial
Funding acknowledgements: This is independent research funded by the NIHR under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-1112-29055).
Topic: Musculoskeletal: spine; Pain & pain management; Disability & rehabilitation
Ethics approval required: Yes
Institution: NHS Research Authority (NRES)
Ethics committee: NRES Committee South Central - Berkshire
Ethics number: 14/SC/0277
All authors, affiliations and abstracts have been published as submitted.
