Clinical trial NCT06487741: Efficacy of a Home-based Stretching Program on Fibromyalgia Symptoms: a Randomised Controlled Trial
Official title: Efficacy of a Home-based Stretching Program on Fibromyalgia Symptoms: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Stretch
Adherence, Treatment
Keywords: Fibromyalgia
Stretching exercises
Home-based
Adherence
Lead sponsor: University College of Northern Denmark
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
name: University of Copenhagen
name: Aalborg University
First posted: 2024-07-05
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Severity of symptoms
timeFrame: Measured at baseline
measure: Severity of symptoms
timeFrame: Measured following 6 weeks of intervention (primary endpoint)
measure: Severity of symptoms
timeFrame: Measured 6 months after the primary endpoint (secondary endpoint)
Secondary outcomes:
measure: Health-Related Quality of life (HRQL)
timeFrame: Measured at baseline
measure: Health-Related Quality of life (HRQL)
timeFrame: Measured following 6 weeks of intervention (primary endpoint)
measure: Health-Related Quality of life (HRQL)
timeFrame: Measured 6 months after the primary endpoint (secondary endpoint)
measure: Self-reported physical activity
timeFrame: Measured at baseline
measure: Self-reported physical activity
timeFrame: Measured following 6 weeks of intervention (primary endpoint)
measure: Self-reported physical activity
timeFrame: Measured 6 months after the primary endpoint (secondary endpoint)
measure: Range of motion
timeFrame: Measured at baseline
measure: Range of motion
timeFrame: Measured following 6 weeks of intervention (primary endpoint)
measure: Pain sensitivity
timeFrame: Measured at baseline
measure: Pain sensitivity
timeFrame: Measured following 6 weeks of intervention (primary endpoint)
Other outcomes:
measure: Adherence
timeFrame: Measured following 6 weeks of intervention (primary endpoint)
Locations:
city: Aalborg
country: Denmark
facility: University College of Northern Denmark
Study officials:
affiliation: Department of Physiotherapy, University College of Northern Denmark
name: Lise Eckardt, Pt. Msc
role: STUDY_DIRECTOR
References: