Adherence, Treatment, Fibromyalgia, Stretch
Conditions
Keywords
Fibromyalgia, Stretching exercises, Home-based, Adherence
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.
Interventions
OTHERHome-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.
Sponsors
Bispebjerg Hospital
University of Copenhagen
Aalborg University
University College of Northern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of symptoms | Measured at baseline | The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of life (HRQL) | Measured at baseline | HRQL is assessed using the Danish version of the Short Form-36 |
| Self-reported physical activity | Measured at baseline | The International Physical Activity Questionnaire (IPAQ) short form |
| Range of motion | Measured at baseline | Passive knee extension range of motion is assessed using the Biodex System 4 Pro isokinetic dynamometer |
| Pain sensitivity | Measured at baseline | Pain sensitivity expressed as pressure pain thresholds are assessed using a handheld electronic pressure algometer |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence | Measured following 6 weeks of intervention (primary endpoint) | Adherence to the intervention is evaluated by the number of days stretching is performed using the self-reported data from the mHealth app. |
Countries
Denmark
Contacts
Primary ContactMorten P Støve, PT. Msc.
Backup ContactAllan Riis, PT. Ph.D.
Outcome results
None listed