Efficacy of a Home-based Stretching Program on Fibromyalgia Symptoms: a Randomised Controlled Trial

Not Applicable

Recruiting

• Conditions: Adherence, Treatment; Fibromyalgia; Stretch
• Interventions: Other: Home-based stretching exercises

• Registration Number: NCT06487741
• Lead Sponsor: University College of Northern Denmark

Brief Summary

This randomised controlled trial will examine the clinical efficacy of a six-week, novel, home-based stretching programme compared to usual care on the effect of symptoms experienced by patients with fibromyalgia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Study First Posted: 2024-07-05
• Study Start: 2024-10-31
• Status Verified: 2024-11
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-17
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• individuals diagnosed with fibromyalgia in accordance with the ACR 2016 diagnostic criteria.
• individuals diagnosed with chronic non-malignant pain or individuals diagnosed with chronic widespread pain (including fibromyalgia syndrome) are also included when they meet the ACR 2016 diagnostic criteria.

Exclusion Criteria

• Non-controlled systemic disorders (such as hypertension, diabetes and coronary insufficiency),
• neurological conditions that impair alertness or comprehension, musculoskeletal conditions that could compromise assessments (such as nerve root compression or knee joint inflammation),
• relevant joint disorders (such as severe arthritis, arthroplasty of the hip or knee, and rheumatoid arthritis),
• recent changes in therapy for fibromyalgia (i.e., within four weeks of baseline).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Home-based stretching exercises	The intervention group receives a home-based rehabilitation program consisting of six weeks of daily static stretching exercises (six minutes a day).

Primary Outcome Measures

Name	Time	Method
Severity of symptoms	Measured 6 months after the primary endpoint (secondary endpoint)	The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score

Secondary Outcome Measures

Name	Time	Method
Self-reported physical activity	Measured 6 months after the primary endpoint (secondary endpoint)	The International Physical Activity Questionnaire (IPAQ) short form
Pain sensitivity	Measured following 6 weeks of intervention (primary endpoint)	Pain sensitivity expressed as pressure pain thresholds are assessed using a handheld electronic pressure algometer
Health-Related Quality of life (HRQL)	Measured 6 months after the primary endpoint (secondary endpoint)	HRQL is assessed using the Danish version of the Short Form-36
Range of motion	Measured following 6 weeks of intervention (primary endpoint)	Passive knee extension range of motion is assessed using the Biodex System 4 Pro isokinetic dynamometer

Trial Locations

Locations (1)

University College of Northern Denmark; 🇩🇰 Aalborg, Denmark