Comparing two physiotherapy approaches for fibromyalgia

Efficacy of a Consensus-Based Physiotherapy Approach Compared to Standardized Usual Care for the Management of Fibromyalgia: A Multicenter Randomized Controlled Trial

This study tests whether a new physiotherapy program that includes education and personalized exercises can help people with fibromyalgia feel less pain and function better compared to standard physiotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Al Hayah University In Cairo (Academic / other)
• Locations: 1 site (Cairo)
• Trial ID: NCT06913868 on ClinicalTrials.gov

What this trial studies

This study compares a new physiotherapy program based on expert consensus with standard physiotherapy for individuals suffering from fibromyalgia. The new program includes education about pain, personalized exercise plans, and coping strategies tailored to each patient. Researchers will assess pain levels, functional ability, and patients' beliefs about pain to determine if the consensus-based approach is more effective than standard care in reducing pain and improving overall function.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with fibromyalgia and experience significant chronic pain.

Not a fit: Patients who do not have a diagnosis of fibromyalgia or those with pain levels below the study's threshold may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment options for patients with fibromyalgia, potentially reducing their pain and improving their quality of life.

How similar studies have performed: While there have been various approaches to treating fibromyalgia, this specific consensus-based physiotherapy program is novel and has not been extensively tested in previous studies.

Eligibility criteria

Inclusion Criteria:

Age: Adults (≥ 18 years of age).

Diagnosis: Diagnosis of fibromyalgia according to the 2016 Revisions to the 2010/2011 Fibromyalgia Diagnostic Criteria (This is the most current and recommended criteria). This requires:

Widespread Pain Index (WPI) ≥ 7 and Symptom Severity Scale (SSS) score ≥ 5 OR WPI 3-6 and SSS score ≥ 9.

Generalized pain, defined as pain in at least 4 of 5 regions (left upper, right upper, left lower, right lower, axial).

Symptoms have been present at a similar level for at least 3 months. A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses.

Pain Intensity: Average pain intensity of ≥ 4/10 on the Numeric Pain Rating Scale (NPRS) over the past week. (This ensures participants have clinically significant pain).

Nociplastic Pain Features:

CSI score ≥ 40. TSK score ≥ 37. Informed Consent: Willingness and ability to provide written informed consent.

Exclusion Criteria:

Red Flags: Presence of "red flags" indicating serious underlying pathology that could mimic fibromyalgia or contraindicate exercise, such as:

Unexplained weight loss. Fever or night sweats. Recent significant trauma. Neurological signs suggestive of spinal cord compression (e.g., bowel or bladder dysfunction, saddle anesthesia).

Suspected malignancy. Acute inflammatory disease. Neurological Disorders: Significant neurological deficits (e.g., multiple sclerosis, Parkinson's disease) that would interfere with participation in the study or confound outcome assessment.

Psychiatric Disorders: Uncontrolled or severe psychiatric disorders (e.g., active psychosis, severe major depression with suicidal ideation) that would preclude informed consent or adherence to the study protocol. Note: Mild to moderate, stable depression or anxiety, common in fibromyalgia, should not be an exclusion criterion.

Overlapping Pain Conditions: Presence of other significant, active pain conditions that could confound the assessment of fibromyalgia-related pain and function, such as:

Active inflammatory arthritis (e.g., rheumatoid arthritis, lupus) requiring ongoing systemic treatment.

Severe osteoarthritis requiring imminent joint replacement. Active, untreated neuropathic pain conditions (e.g., diabetic neuropathy, post-herpetic neuralgia). Note: Stable, well-managed comorbidities should not be exclusionary.

Current Pain Management: Current participation in other pain management programs or interventions that specifically overlap with the study interventions (e.g., another structured physiotherapy program, cognitive behavioral therapy specifically for pain). Note: Patients on stable doses of pain medication should not be excluded.

Exercise Contraindications: Inability to participate in exercise therapy due to medical conditions (e.g., severe cardiovascular disease, uncontrolled hypertension).

Pregnancy: Current pregnancy or planning to become pregnant during the study period. (Pregnancy can affect pain perception and exercise tolerance).

Medication Changes: Recent changes (within the past 4 weeks) in pain-related medications (e.g., opioids, antidepressants, anticonvulsants) or planned changes during the study period. Note: Stable medication regimens are acceptable.

Litigation: Current involvement in litigation related to their fibromyalgia or chronic pain.

Where this trial is running

Cairo

• Faculty of Physical Therapy, Al Hayah University — Cairo, Egypt (Recruiting)

Study contacts

• Study coordinator: Mohamed ElMeligie, Ph.D

Conditions Chronic Pain; Fibromyalgia