Title: A randomised controlled trial of brief physiotherapy informed by Acceptance and Commitment Therapy for chronic low back pain: the PACT study
Funder: Department of Health (England)

Abstract: Background: Chronic low back pain (CLBP) is a common disabling condition causing much suffering and costing the NHS and society billions of pounds each year. Current treatments vary considerably and are only moderately effective, so new approaches are warranted. Most people with CLBP have physiotherapy but evidence suggests that cognitive behaviour therapy (CBT) may be more effective in the long run because it helps people to self-manage their condition . However, psychologists are largely unavailable for patients with CLBP and physiotherapists require extra training in CBT. There are important questions requiring investigated about the most effective type of CBT for physiotherapist delivery, the optimum duration of treatment and training package required by these clinicians. A new type of CBT called Acceptance and Commitment Therapy (ACT) has recently produced particularly good results for chronic pain but has not yet been evaluated in physiotherapy-led treatment. The proposed study builds on our feasibility study, where our team developed a brief physiotherapist delivered ACT-based treatment (PACT) which promotes psychological flexibility, encouraging people to accept pain and still move forward with their lives. Nine patients had promising results after PACT, all showing clinically important improvement in self-reported disability on the RMDQ, with a medium-large effect-size. Findings from structured interviews suggested that the treatment was acceptable to patients and staff and could be effectively delivered by a physiotherapist. Aims: To evaluate the efficacy of PACT compared to usual physiotherapy. Secondary aims are to develop a PACT training package for physiotherapists and collect data to inform design of a definitive multi-centre pragmatic RCT with cost-utility analysis. Design and setting: A phase 2 RCT comparing PACT with usual physiotherapy in three south London hospital physiotherapy outpatient departments. Interventions : PACT consists of two 60 minute face-to-face sessions one week apart, comprising assessment, individualised treatment and exercise prescription, plus one follow-up phone call one month later. Usual physiotherapy consists of any treatment deemed appropriate by clinician. Six trial physiotherapists (2 per hospital) will be trained to deliver PACT. Different clinicians will deliver usual physiotherapy to avoid contamination. Participants: 240 people aged >18 with non-specific CLBP suitable for physiotherapy referred to GSTT and KCH for physiotherapy will be recruited by local research physiotherapists and randomized via King’s CTU to PACT or usual physiotherapy. Sample size and recruitment rate: 240 participants provides adequate power to detect a standardised mean difference of 0.40 in primary outcome, Roland-Morris Disability Questionnaire (RMDQ), at 5% significance, 80% power, assuming 20% attrition. Our previous RTCs on CLBP in these hospitals suggest recruitment over 16 months (15 participants/month) is realistic. Data collection and outcomes: Assessments by RA blind to allocation at baseline, 3 months (primary outcome point) and 12 months post-randomisation. Primary outcome will be self-reported disability using the RMDQ, secondary outcomes include patient goals (patient specific functional scale), pain (numerical analogue scale), acceptance of pain (Chronic Pain Acceptance Questionnaire), mood (HADS), and Fear-Avoidance (Tampa Scale of Kinesiophobia). Cost and effectiveness data will be collected to inform a future definitive trial with economic analysis. Nested qualitative study consisting semi-structured interviews with 20-25 participants will explore patient’s and staff’s perceptions of PACT and evaluate the acceptability of both the interventions and the training. Benefits to NHS and patients: This is a well-designed, rigorous trial with long-term outcome that will enable clinicians, patients and commissioners to make informed decisions about the management of CLBP. If PACT is successful, we plan a larger multi-centre trial to determine the effectiveness and cost-effectiveness. Patients want individualised treatment and help to self-manage their CLBP. PACT represents the effective use of health care resources for patients, the NHS and society at large.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.7 PHYSICAL
Health categories: MUSCULOSKELETAL