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

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.

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia; Adherence, Treatment; Stretch
• Intervention / Treatment: Other: Home-based stretching exercises

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allan Riis, PT. Ph.D.; Phone Number: +4572691310; Email: alr@ucn.dk
• Study Contact Backup: Name: Morten P Støve, PT. Msc.; Phone Number: 72691004; Email: mps@ucn.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9220
    • Recruiting
    • University College of Northern Denmark
    • Contact: Morten P Støve, PT, Msc.; Phone Number: 004522980862; Email: mps@ucn.dk
    • Principal Investigator: Morten P Støve, PT, Msc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention group receives a home-based rehabilitation program consisting of six weeks of daily static stretching exercises (six minutes a day).	Other: Home-based stretching exercises; 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.
No Intervention: Control; The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Adherence to the intervention is evaluated by the number of days stretching is performed using the self-reported data from the mHealth app.	Measured following 6 weeks of intervention (primary endpoint)

Collaborators and Investigators

• Sponsor: University College of Northern Denmark
• Collaborators: University of Copenhagen; Bispebjerg Hospital; Aalborg University
• Investigators: Study Director: Lise Eckardt, Pt. Msc, Department of Physiotherapy, University College of Northern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Adherence; Fibromyalgia; Home-based; Stretching exercises
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: Fibromyalgia RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol will be published open access. Data is made available upon reasonable request.
• IPD Sharing Time Frame: The study protocol will be published open access.
• IPD Sharing Access Criteria: Data is made available upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No