Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): a randomised, controlled, three-arm, parallel group, phase 3, clinical trial
Four pages on PainSci cite Kent 2023: 1. The Complete Guide to Low Back Pain 2. Cognitive Behavioural Therapy for Chronic Pain 3. Mind Over Pain 4. Reluctantly Reconsidering RESTORE
Common issues and characteristics relevant to this paper: ?Scientific papers have many common characteristics, flaws, and limitations, and many of these are rarely or never acknowledged in the paper itself, or even by other reviewers. I have reviewed thousands of papers, and described many of these issues literally hundreds of times. Eventually I got sick of repeating myself, and so now I just refer to a list common characteristics, especially flaws. Not every single one of them applies perfectly to every paper, but if something is listed here, it is relevant in some way. Note that in the case of reviews, the issue may apply to the science being reviewed, and not the review itself.
- Reaching beyond the data with the interpretation, conclusions, and/or public representation of trial results.
original abstract †Abstracts here may not perfectly match originals, for a variety of technical and practical reasons. Some abstacts are truncated for my purposes here, if they are particularly long-winded and unhelpful. I occasionally add clarifying notes. And I make some minor corrections.
BACKGROUND: Low back pain is the leading cause of years lived with disability globally, but most interventions have only short-lasting, small to moderate effects. Cognitive functional therapy (CFT) is an individualised approach that targets unhelpful pain-related cognitions, emotions, and behaviours that contribute to pain and disability. «Note that premise: “thoughts and feelings partially cause pain and disability.”» Movement sensor biofeedback might enhance treatment effects. We aimed to compare the effectiveness and economic efficiency of CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling low back pain.
METHODS: RESTORE was a randomised, controlled, three-arm, parallel group, phase 3 trial, done in 20 primary care physiotherapy clinics in Australia. We recruited adults (aged ≥18 years) with low back pain lasting more than 3 months with at least moderate pain-related physical activity limitation. Exclusion criteria were serious spinal pathology (eg, fracture, infection, or cancer), any medical condition that prevented being physically active, being pregnant or having given birth within the previous 3 months, inadequate English literacy for the study's questionnaires and instructions, a skin allergy to hypoallergenic tape adhesives, surgery scheduled within 3 months, «Surgical candidates is a huge sub-group to exclude — noteworthy.» or an unwillingness to travel to trial sites. Participants were randomly assigned (1:1:1) via a centralised adaptive schedule to usual care, CFT only, or CFT plus biofeedback. The primary clinical outcome was activity limitation at 13 weeks, self-reported by participants using the 24-point Roland Morris Disability Questionnaire. The primary economic outcome was quality-adjusted life-years (QALYs). Participants in both interventions received up to seven treatment sessions over 12 weeks plus a booster session at 26 weeks. Physiotherapists and patients were not masked. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001396213.
FINDINGS: Between Oct 23, 2018 and Aug 3, 2020, we assessed 1011 patients for eligibility. After excluding 519 (51·3%) ineligible patients, we randomly assigned 492 (48·7%) participants; 164 (33%) to CFT only, 163 (33%) to CFT plus biofeedback, and 165 (34%) to usual care. Both interventions were more effective than usual care (CFT only mean difference -4·6 [95% CI -5·9 to -3·4] and CFT plus biofeedback mean difference -4·6 [-5·8 to -3·3]) for activity limitation at 13 weeks (primary endpoint). «So drops of 4.6 more points on a 24-point scale compared to usual care. » Effect sizes were similar at 52 weeks. Both interventions were also more effective than usual care for QALYs, and much less costly in terms of societal costs (direct and indirect costs and productivity losses; -AU$5276 [-10529 to -24) and -8211 (-12923 to -3500).
INTERPRETATION: CFT can produce large «where is this "large" improvement?» and sustained improvements for people with chronic disabling low back pain at considerably lower societal cost than that of usual care.
FUNDING: Australian National Health and Medical Research Council and Curtin University.
related content
- “Efficacy of classification-based cognitive functional therapy in patients with non-specific chronic low back pain: A randomized controlled trial,” Vibe-Fersum et al, European Journal of Pain, 2013.
- “Multidisciplinary biopsychosocial rehabilitation for chronic low back pain,” Kamper et al, Cochrane Database of Systematic Reviews, 2014.
- “15 things you didn't know about back pain,” Mary O’Keeffe, www.independent.ie.
- “Comparative Effectiveness of Conservative Interventions for Nonspecific Chronic Spinal Pain: Physical, Behavioral/Psychologically Informed, or Combined? A Systematic Review and Meta-Analysis,” O’Keeffe et al, Journal of Pain, 2016.
- “Non-pharmacological treatment of low back pain in primary care,” O’Keeffe, Drug and Therapeutics Bulletin, 2019.
- “Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT),” O'Keeffe et al, British Journal of Sports Medicine, 2020.
Specifically regarding Kent 2023:
- “Cognitive functional therapy for chronic disabling low back pain,” Meziat-Filho et al, Lancet, 2023.
- restorebackpain.com
This page is part of the PainScience BIBLIOGRAPHY, which contains plain language summaries of thousands of scientific papers & others sources. It’s like a highly specialized blog. A few highlights:
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- Topical glyceryl trinitrate (GTN) and eccentric exercises in the treatment of mid-portion achilles tendinopathy (the NEAT trial): a randomised double-blind placebo-controlled trial. Kirwan 2024 Br J Sports Med.
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