Clinical trial NCT06913868: Consensus-Based vs. Standardized Physiotherapy for Fibromyalgia
Official title: Efficacy of a Consensus-Based Physiotherapy Approach Compared to Standardized Usual Care for the Management of Fibromyalgia: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Fibromyalgia
Lead sponsor: Al Hayah University In Cairo
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares a new, consensus-based physiotherapy program to standard physiotherapy for people with fibromyalgia. The new program uses recommendations from experts, including education about pain, personalized exercise, and strategies to improve coping skills. We will measure how much pain people have, how well they can function, and their beliefs about pain. The goal is to see if the new program is better than standard care at reducing pain and improving function in individuals with fibromyalgia.


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.

Primary outcomes:
measure: Change in Pain Disability Index (PDI)
timeFrame: Baseline, 8 weeks (post-intervention)
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
measure: Central Sensitization Inventory (CSI)
timeFrame: Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
measure: Patient Global Impression of Change (PGIC)
timeFrame: 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Al Hayah University
Study officials:
References: