Efficacy of a home-based stretching programme on fibromyalgia symptoms: study protocol for a randomised controlled trial.
Morten Pallisgaard Støve, Stig Peter Magnusson, Janus Laust Thomsen...
https://pubmed.ncbi.nlm.nih.gov/40016827Actively Recruiting
Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID06487741
Efficacy of a Home-based Stretching Program on Fibromyalgia Symptoms: a Randomised Controlled Trial
Led by University College of Northern Denmark · Updated on 2025-02-17
58
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University College of Northern Denmark
Lead Sponsor
B
Bispebjerg Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effects of a new six-week home-based stretching program on symptoms experienced by patients with fibromyalgia. This randomized controlled trial compares this stretching program to usual care to understand its impact on symptom severity. The study is sponsored by the University College of Northern Denmark and includes adults diagnosed with fibromyalgia or related chronic widespread pain according to specific criteria. Participants in the intervention group will perform daily static stretching exercises at home for six minutes each day over six weeks. These exercises involve two sets of 30-second stretches targeting the knee flexors, hip abductors, and shoulder elevators, based on recommendations from the American College of Sports Medicine. The control group will continue their usual care without changes to current treatments or starting new exercise routines. During the study, participants will have their symptom severity, health-related quality of life, self-reported physical activity, range of motion, and pain sensitivity measured at the start, after six weeks of intervention, and again six months later. The trial uses double-blind methods and randomization to assign participants to groups. This enables careful monitoring of the stretching program's effects compared to standard care over time.
CONDITIONS
Brief Title
Efficacy of a Home-based Stretching Program on Fibromyalgia Symptoms: a Randomised Controlled Trial
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with fibromyalgia according to the ACR 2016 diagnostic criteria.
- Diagnosed with chronic non-malignant pain or chronic widespread pain meeting the ACR 2016 criteria.
- Adults aged between 18 and 60 years.
You will not qualify if you...
- Uncontrolled systemic disorders such as hypertension, diabetes, or coronary insufficiency.
- Neurological conditions that impair alertness or comprehension.
- Musculoskeletal conditions that may affect assessments, including nerve root compression or knee joint inflammation.
- Severe joint disorders such as severe arthritis, hip or knee arthroplasty, or rheumatoid arthritis.
- Recent changes in fibromyalgia therapy within four weeks before baseline.
AI-Screening
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 weeks
Participants in the intervention group perform daily home-based static stretching exercises for six weeks. The control group maintains their usual care without changing treatments or starting new exercises.
Weekly visits for assessment
Follow-up
Duration - 6 months
Participants are followed for six months after completing the intervention to assess long-term effects on fibromyalgia symptoms and quality of life.
1 follow-up visit at 6 months
Trial Site Locations
Total: 1 location
1
University College of Northern Denmark
Aalborg, Denmark, 9220
Actively Recruiting
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Research Team
M
Morten P Støve, PT. Msc.
A
Allan Riis, PT. Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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