Efficacy of a Home-based Stretching Program on Fibromyalgia Symptoms: a Randomised Controlled Trial
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2024
CompletedFirst Posted
Study publicly available on registry
July 5, 2024
CompletedStudy Start
First participant enrolled
October 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2026
February 17, 2025
November 1, 2024
1.8 years
June 27, 2024
February 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Severity of symptoms
The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
Measured at baseline
Severity of symptoms
The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
Measured following 6 weeks of intervention (primary endpoint)
Severity of symptoms
The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
Measured 6 months after the primary endpoint (secondary endpoint)
Secondary Outcomes (10)
Health-Related Quality of life (HRQL)
Measured at baseline
Health-Related Quality of life (HRQL)
Measured following 6 weeks of intervention (primary endpoint)
Health-Related Quality of life (HRQL)
Measured 6 months after the primary endpoint (secondary endpoint)
Self-reported physical activity
Measured at baseline
Self-reported physical activity
Measured following 6 weeks of intervention (primary endpoint)
- +5 more secondary outcomes
Other Outcomes (1)
Adherence
Measured following 6 weeks of intervention (primary endpoint)
Study Arms (2)
Intervention
EXPERIMENTALThe intervention group receives a home-based rehabilitation program consisting of six weeks of daily static stretching exercises (six minutes a day).
Control
NO INTERVENTIONThe control group receives usual care, and no change in treatment is made. Participants will be encouraged to maintain their daily routine but refrain from changing the current pharmacological treatment or initiating new physical exercise practices during the study.
Interventions
The intervention comprises six weeks of daily static stretching exercises (six minutes a day) in accordance with the recommendation of the American College of Sports Medicine. The intervention is self-administered and consists of two bouts of 30-second bilateral static stretches of the knee flexors, hip abductors, and shoulder elevators.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College of Northern Denmarklead
- Bispebjerg Hospitalcollaborator
- University of Copenhagencollaborator
- Aalborg Universitycollaborator
Study Sites (1)
University College of Northern Denmark
Aalborg, 9220, Denmark
Related Publications (1)
Stove MP, Magnusson SP, Thomsen JL, Riis A. Efficacy of a home-based stretching programme on fibromyalgia symptoms: study protocol for a randomised controlled trial. Trials. 2025 Feb 27;26(1):74. doi: 10.1186/s13063-025-08776-z.
PMID: 40016827DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lise Eckardt, Pt. Msc
Department of Physiotherapy, University College of Northern Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants are blinded to the results of the pressure pain threshold measurements. Participants and the outcome assessor are blinded to the range of motion measurement results. The outcome assessor (MPS) is blinded to the outcome of the FIQ-R, SF-36 and IPAQ questionnaires. Blinding participants and the care provider (MPS) from delivering the intervention from treatment allocation is contrary to the nature of the investigated intervention and, therefore, is not considered feasible.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2024
First Posted
July 5, 2024
Study Start
October 31, 2024
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
August 30, 2026
Last Updated
February 17, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The study protocol will be published open access.
- Access Criteria
- Data is made available upon request.
The study protocol will be published open access. Data is made available upon reasonable request.