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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2026-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Feasibility and Acceptability of Home-based Stretching Exercises in Fibromyalgia

NCT06176053

Fibromyalgia Pain Quality of Life

COMPLETED NA

Supervised and Home Training in Fibromyalgia

NCT06956456

Fibromyalgia

COMPLETED NA

Efficacy of Different Types of Exercises in Women With Fibromyalgia Syndrome.

NCT04426864

Fibromyalgia Syndrome

COMPLETED NA

FIBROmyalgia: Somatic Tracking and Exercise Program Study

NCT06922747

Fibromyalgia (FM) Fibromyalgia Fibromyalgia Syndrome

NOT_YET_RECRUITING NA

Myofascial Release of Physiological Chains and Muscle Stretching in Patients With Fibromyalgia

NCT03408496

Fibromyalgia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia Stretch Adherence, Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

The intervention group receives a home-based rehabilitation program consisting of six weeks of daily static stretching exercises (six minutes a day).

Group Type EXPERIMENTAL

Home-based stretching exercises

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No