NCT06913868

Consensus-Based vs. Standardized Physiotherapy for Fibromyalgia

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Al Hayah University In Cairo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pain
• Fibromyalgia

Interventions

Type	Name	Description
BEHAVIORAL	Consensus-Based Physiotherapy Program	Physiotherapy for fibromyalgia (Baroni et al., 2023 Delphi consensus). Includes pain neuroscience education (PNE), tailored aerobic, strengthening, and sensorimotor exercises (graded exposure), and self-management strategies. 8-week program: 1-2 sessions/week (60 min) + home exercise (20 min, 3x/week). Therapist training and fidelity monitoring.Pain Neuroscience Education (PNE): Approximately 20 minutes per session, focusing on explaining the neurobiology of pain in fibromyalgia, emphasizing central sensitization mechanisms, and reconceptualizing pain as an output of the brain rather than solely a marker of tissue damage. PNE aims to reduce threat value associated with pain and improve understanding of pain fluctuations.
BEHAVIORAL	Standardized Physiotherapy Care	Standardized physiotherapy for fibromyalgia. Includes general exercise (aerobic, stretching), manual therapy (within guidelines), and basic pain education (excluding PNE). 8-week program: 1-2 sessions/week (60 min) + home exercise (20 min, 3x/week). Therapist training and fidelity monitoring.

Timeline

• Start date: 2025-04-21
• Primary completion: 2028-04-21
• Completion: 2028-04-21
• First posted: 2025-04-06
• Last updated: 2025-04-06

Locations

1 site across 1 country: Egypt