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

ConditionsFibromyalgia Stretch Adherence, Treatment

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorUniversity College of Northern Denmark

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

Home-based stretching exercises
Other intervention
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.

Treatment groups

58 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Severity of symptoms

The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score

Time frame

Measured at baseline

Severity of symptoms

The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score

Time frame

Measured following 6 weeks of intervention (primary endpoint)

Severity of symptoms

The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score

Time frame

Measured 6 months after the primary endpoint (secondary endpoint)

Secondary outcomes

Health-Related Quality of life (HRQL)

HRQL is assessed using the Danish version of the Short Form-36

Time frame

Measured at baseline

Health-Related Quality of life (HRQL)

HRQL is assessed using the Danish version of the Short Form-36

Time frame

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

Time frame

Measured 6 months after the primary endpoint (secondary endpoint)

Self-reported physical activity

The International Physical Activity Questionnaire (IPAQ) short form

Time frame

Measured at baseline

Other outcomes

Adherence

Adherence to the intervention is evaluated by the number of days stretching is performed using the self-reported data from the mHealth app.

Time frame

Measured following 6 weeks of intervention (primary endpoint)

Sponsors and contacts

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University College of Northern Denmark

Lead sponsor

Bispebjerg Hospital

Collaborator

University of Copenhagen

Collaborator

Aalborg University

Collaborator

Source ClinicalTrials.gov

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