Efficacy of a home-based stretching programme on fibromyalgia symptoms: study protocol for a randomised controlled trial

BACKGROUND: This protocol was developed to describe the design of a randomised controlled trial that will examine the clinical efficacy of a 6-week, novel, home-based stretching programme compared with usual care on the effect of symptoms experienced by patients with fibromyalgia. The hypothesis is that the total score of the Fibromyalgia Impact Questionnaire (FIQ-R) and other fibromyalgia symptoms will improve 6 weeks following the stretching intervention compared with usual care.

METHODS: Fifty-eight adults under 65 years of age diagnosed with fibromyalgia will be recruited for this study. Participants will be randomised into an intervention group and a control group (waitlist). Randomisation will be stratified by sex. The intervention group will perform 6 weeks of daily stretching exercises for 6 min-a day. The control group will maintain usual care. A mHealth app will support stretching adherence. The primary outcome will be the total score of the Revised Fibromyalgia Impact Questionnaire (FIQ-R). The secondary outcomes include regional and widespread pain sensitivity, range of motion, quality of life (SF-36), mental and physical functioning and adherence. Evaluations will be performed at baseline, following 6 weeks of daily stretches (primary endpoint) and 6 months after the termination of the intervention period (secondary endpoint).

DISCUSSION: By investigating the clinical efficacy of a 6-week, novel, home-based stretching programme, we hope to provide applicable and generalisable knowledge about the efficacy of stretching exercises that can potentially help ease the burden of symptoms experienced by patients with fibromyalgia.

TRIAL REGISTRATION: NTC, NCT06487741. Registered on 24 June 2024.