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Recruiting NCT06913868

Consensus-Based vs. Standardized Physiotherapy for Fibromyalgia

Trial Parameters

Condition Chronic Pain
Sponsor Al Hayah University In Cairo
Study Type INTERVENTIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-04-21
Completion 2028-04-21
Interventions
Consensus-Based Physiotherapy ProgramStandardized Physiotherapy Care

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 inform

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