RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial.
Australia
Biofeedback, Psychology
/ instrumentation
Chronic Pain
/ diagnosis
Cognitive Behavioral Therapy
/ methods
Cost-Benefit Analysis
Disability Evaluation
Exercise
Humans
Low Back Pain
/ diagnosis
Movement
Multicenter Studies as Topic
Pain Measurement
Physical Therapy Modalities
Quality-Adjusted Life Years
Randomized Controlled Trials as Topic
Recovery of Function
Transducers
Treatment Outcome
clinical trial protocol
low back pain
rehabilitation
wearable electronic devices
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
18 08 2019
18 08 2019
Historique:
entrez:
21
8
2019
pubmed:
21
8
2019
medline:
15
9
2020
Statut:
epublish
Résumé
Low back pain (LBP) is the leading cause of disability globally and its costs exceed those of cancer and diabetes combined. Recent evidence suggests that individualised cognitive and movement rehabilitation combined with lifestyle advice (cognitive functional therapy (CFT)) may produce larger and more sustained effects than traditional approaches, and movement sensor biofeedback may enhance outcomes. Therefore, this three-arm randomised controlled trial (RCT) aims to compare the clinical effectiveness and economic efficiency of individualised CFT delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling LBP. Pragmatic, three-arm, randomised, parallel group, superiority RCT comparing usual care (n=164) with CFT (n=164) and CFT-plus-movement-sensor-biofeedback (n=164). Inclusion criteria include: adults with a current episode of LBP >3 months; sought primary care ≥6 weeks ago for this episode of LBP; average LBP intensity of ≥4 (0-10 scale); at least moderate pain-related interference with work or daily activities. The CFT-only and CFT-plus-movement-sensor-biofeedback participants will receive seven treatment sessions over 12 weeks plus a 'booster' session at 26 weeks. All participants will be assessed at baseline, 3, 6, 13, 26, 40 and 52 weeks. The primary outcome is pain-related physical activity limitation (Roland Morris Disability Questionnaire). Linear mixed models will be used to assess the effect of treatment on physical activity limitation across all time points, with the primary comparison being a formal test of adjusted mean differences between groups at 13 weeks. For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L . Approved by Curtin University Human Research Ethics Committee (HRE2018-0062, 6 Feb 2018). Study findings will be disseminated through publication in peer-reviewed journals and conference presentations. Australian New Zealand Clinical Trials Registry (ACTRN12618001396213).
Identifiants
pubmed: 31427344
pii: bmjopen-2019-031133
doi: 10.1136/bmjopen-2019-031133
pmc: PMC6701662
doi:
Banques de données
ANZCTR
['ACTRN12618001396213']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e031133Informations de copyright
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: JPC, KOS and POS deliver continuing education workshops on Cognitive Functional Therapy, for which they receive honoraria.
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