Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): 3-year follow-up of a randomised, controlled trial
- PMID: 40780241
- DOI: 10.1016/S2665-9913(25)00135-3
Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): 3-year follow-up of a randomised, controlled trial
Abstract
Background: Interventions for low back pain typically produce small and short-term effects. Cognitive functional therapy (CFT) has shown large effects up to 12 months, but long-term effects are unclear. We aimed to compare the long-term (3-year) effectiveness of CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic disabling low back pain.
Methods: The RESTORE trial was a randomised, controlled, three-arm parallel group, phase 3, clinical trial that investigated CFT delivered with or without biofeedback compared with usual care for the treatment of chronic low back pain. Treatment was delivered in 20 primary care physiotherapy clinics in Australia. This study is the 3-year follow-up of the RESTORE trial. We recruited adults (aged ≥18 years) with low back pain lasting more than 3 months with at least moderate pain-related physical activity limitation and average back pain of at least 4 on a 0-10 scale. Participants were randomly assigned (1:1:1) via a centralised adaptive schedule to usual care, CFT only, or CFT plus biofeedback. At the 1-year follow-up, all participants were invited to provide consent to be followed up 2 years later-ie, 3 years after randomisation. The primary outcome was pain-related physical activity limitation, self-reported via the Roland Morris Disability Questionnaire (0-24 scale) at 3 years. The secondary outcome was pain intensity at 3 years, assessed using the numeric pain rating scale. Adverse event data were not collected at the 3-year follow-up. All outcomes were assessed in the intention-to-treat population. Participants in both CFT groups received up to seven treatment sessions over 12 weeks plus a booster session at 26 weeks. Physiotherapists and patients were not masked. People with lived experience of chronic low back pain were involved in the study design and conduct. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618001396213).
Findings: Between Oct 23, 2018, and Aug 3, 2020, 1011 people were assessed for eligibility for the RESTORE trial. 492 (49%) were eligible and randomly assigned to one of three treatments; 164 (33%) to CFT only, 163 (33%) to CFT plus biofeedback, and 165 (34%) to usual care. At the 1-year follow-up, 359 (73%) of 492 participants provided consent to be contacted to complete the 3-year questionnaire. 312 (87%) of those 359 participants were successfully followed up at 3 years, with similar proportions across each treatment group; 104 (63%) of 164 in the CFT only group, 106 (65%) of 163 in the CFT plus biofeedback group, and 102 (62%) of 165 in the usual care group. 188 (60%) of 312 participants were female, 124 (40%) were male, and the mean age was 48·1 years (SD 14·6). CFT only (mean difference -3·5 [95% CI -4·9 to -2·0]) and CFT plus biofeedback (-4·1 [-5·6 to -2·6]) were both more effective than usual care in reducing activity limitation at 3 years. Differences between CFT only and CFT plus biofeedback treatments were small and not significant (mean difference -0·6 [95% CI -2·2 to 0·9]). For pain intensity at 3 years, CFT only (-1·0 [-1·6 to -0·5]) and CFT plus biofeedback (-1·5 [-2·1 to -0·9]) were also more effective than usual care, and differences between CFT only and CFT plus biofeedback were small and not significant (-0·5 [-1·1 to 0·1]).
Interpretation: Treatment sessions of CFT produced sustained effects at 3 years for people with chronic disabling low back pain. These long-term effects are novel and provide the opportunity to markedly reduce the effect of chronic back pain if the intervention can be widely implemented. Implementation requires scaling up of clinician training to increase accessibility and replication studies in diverse health-care systems.
Funding: Australian National Health and Medical Research Council and Curtin University.
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Conflict of interest statement
Declaration of interests MH, PO'S, JPC, AC, and AS hold research grants from the National Health and Medical Research Council and the Medical Research Future Fund, both Australian Government medical research funding agencies. MH has also received research grants from the Physiotherapy Research Foundation, Australian Chiropractors Education and Research Foundation, and Canadian Institutes of Health Research; received honoraria paid to his university for giving lectures to the Korean Academy Maitland Orthopedic Manipulative Physical Therapy, Korean Gyeonggi-do Physical Therapy Association, and Bodycare; and travel expenses covered for invited speaking engagements at the Australian Physiotherapy Conference, Korean Academy Maitland Orthopedic Manipulative Physical Therapy, Korean Gyeonggi-do Physical Therapy Association, Amref International University, and Australian Chiropractic Association. MH, RL, DW, and RC are members of the Australian Physiotherapy Association, with RL also being a member of the Australian College of Physiotherapists. PO'S has received funds from New South Wales Emergency Services and honoraria for running clinical workshops on person-centred care for the International Federation of Manipulative Physiotherapists, Royal North Shore Hospital, and James Davis Physiotherapy. PO'S had travel expenses covered for invited speaking engagements at the International Federation of Manipulative Physiotherapists, New Zealand Pain Society, Faculty of Pain Medicine Australia, International Association for the Study of Pain, New Zealand Physiotherapy, British Spine Association, and UK National Spine Network. PO'S and JPC are directors of Bodylogic Physiotherapy, a practice in Western Australia providing person-centred care for musculoskeletal pain problems, and directors of Evoolve Pain Care Academy, a social enterprise providing education to clinicians on person-centred care, without receiving any income or dividends in this role. PK works part-time in an unpaid capacity for Evoolve Pain Care Academy. JPC, RS and KO'S have received speaker fees for lectures or workshops on the biopsychosocial management of pain, including on cognitive functional therapy, from special interest physiotherapy groups and multidisciplinary audiences of clinicians and researchers. JPC's travel expenses have been covered for invited speaking engagements at the Australian Pain Society and Australian Physiotherapy Association. KO'S holds research grants from the Irish Research Council and Pain Alliance Europe, with previous grants from the Irish Research Council, Health Research Board of Ireland, Irish Society of Chartered Physiotherapists, and Pain Alliance Europe; received speaker fees and travel expenses for invited speaking engagements at the Irish Society of Chartered Physiotherapists, Irish Pain Nurses Association, Trust-me Ed, DenkFysio, Canadian Physiotherapy Association, Norwegian Physiotherapist Association, and UP Education; had travel expenses covered, along with small honoraria, for invited speaking engagements at conferences for the European Chiropractor Union, Irish Society of Chartered Physiotherapists, International Olympic Committee, Scandinavian Sports Congress, and European Conference of Manual Therapy; and is a fellow of the Irish Society of Chartered Physiotherapists and was previously National Director of Professional Development for the Irish Society of Chartered Physiotherapists and a member of their national board, having served on the professional practice working group of World Physiotherapy-Europe. JH holds several grants from Danish and international agencies, including the EU, Swiss Medical Research Council, Danish Regions, Norwegian Medical Research Council, and Health Insurance Denmark; has received reimbursement for travel and accommodation expenses for invited lectures from the Danish Board of Health, World federation of Chiropractic, Swedish Chiropractor's Association, Norwegian Chiropractor's Association, Danish Physiotherapy Association, Swedish Naprapathic Association, Danish Medical Association, Health Insurance Denmark, Sports Congress, British Columbia Chiropractic Association, McKenzie Organization International, Pension Denmark, University of Copenhagen, People's University Denmark, Steno Diabetes Center Copenhagen, Danish Rheumatology Society, Danish Regions, Norwegian Musculoskeletal Network, World Congress on Low Back and Pelvic Pain, Chiropractic Australia, German Sports Medicine Society, European Pain Federation, Pain in Motion, Region Zealand, Region South, and Swiss Chiropractor's Association over the past 5 years; and is a member of the Danish Chiropractor's Association. RC has received a scholarship to support PhD research with data from the RESTORE trial. RS received funding from Raine Clinician Research Fellowship funded by Future Health Research and Innovation Fund and Insurance Commission of Western Australia.
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