Fibromyalgia & musculoskeletal pain
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
Authors' conclusion
Treatment sessions of CFT produced sustained effects at 3 years for people with chronic disabling low back pain.
Study context
- Population
- Adults (≥18 years) with low back pain >3 months, at least moderate pain-related physical activity limitation and average back pain ≥4 on 0–10 scale; 20 primary care physiotherapy clinics, Australia312 followed up at 3 years
- Participants
- 492 adults
- Comparison
- Cognitive functional therapy (CFT) only or CFT plus biofeedback vs usual care
- CFT onlyn = 164
- CFT plus biofeedbackn = 163
- Usual caren = 165reference
- Primary endpoint
- Pain-related physical activity limitation (Roland Morris Disability Questionnaire, 0-24)
- Follow-up
- 3 years
Methodological details3-year follow-up, three-arm parallel group, phase 3, multicentre (20 primary care physiotherapy clinics), unmasked physiotherapists and patients, Adverse event data were not collected at the 3-year follow-up
- 3-year follow-up
- Three-arm parallel group
- Phase 3
- Multicentre (20 primary care physiotherapy clinics)
- Unmasked physiotherapists and patients
- Adverse event data were not collected at the 3-year follow-up
Primary result
As reported in the abstract
Activity limitation (Roland Morris, 0-24)
Mean difference (95% CI)
CFT onlyvs Usual care
−3.5(−4.9 to −2.0)
CFT plus biofeedbackvs Usual care
−4.1(−5.6 to −2.6)
CFT onlyvs CFT plus biofeedbacksmall and not significant
−0.6(−2.2 to 0.9)
Secondary outcomes
| Outcome | Mean difference (95% CI) | |
|---|---|---|
| Pain intensity (numeric pain rating scale) · 3 yearsCFT onlyvs Usual careIntention-to-treat | −1.0 (−1.6 to −0.5) | |
| Pain intensity (numeric pain rating scale) · 3 yearsCFT plus biofeedbackvs Usual careIntention-to-treat | −1.5 (−2.1 to −0.9) | |
| Pain intensity (numeric pain rating scale) · 3 yearsCFT onlyvs CFT plus biofeedbackSmall and not significant · intention-to-treat | −0.5 (−1.1 to 0.1) | |
| −3−2−101Difference (linear scale) |
Original publication
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. Lancet Rheumatol. Published 6 August 2025. doi:10.
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