Actively Recruiting
Consensus-Based vs. Standardized Physiotherapy for Fibromyalgia
Led by Al Hayah University In Cairo · Updated on 2025-04-06
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Consensus-Based vs. Standardized Physiotherapy for Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with fibromyalgia according to the 2016 Revisions to the 2010/2011 Fibromyalgia Diagnostic Criteria
- Widespread Pain Index (WPI) of 7 or higher and Symptom Severity Scale (SSS) score of 5 or higher, or WPI 3-6 and SSS score 9 or higher
- Generalized pain in at least 4 of 5 body regions
- Symptoms present at a similar level for at least 3 months
- Average pain intensity of 4 or higher on the Numeric Pain Rating Scale over the past week
- Central Sensitization Inventory (CSI) score 40 or higher
- Tampa Scale of Kinesiophobia (TSK) score 37 or higher
- Willingness and ability to provide written informed consent
You will not qualify if you...
- Presence of red flags indicating serious underlying conditions, such as unexplained weight loss, fever, night sweats, recent significant trauma, neurological signs of spinal cord compression, suspected malignancy, or acute inflammatory disease
- Significant neurological disorders interfering with participation or outcome assessment
- Uncontrolled or severe psychiatric disorders preventing informed consent or adherence
- Other significant active pain conditions that could confuse assessment, including active inflammatory arthritis, severe osteoarthritis needing joint replacement, or untreated neuropathic pain
- Current participation in other pain management programs overlapping with study interventions
- Inability to participate in exercise therapy due to medical conditions like severe cardiovascular disease or uncontrolled hypertension
- Current pregnancy or plans to become pregnant during the study
- Recent changes in pain-related medications within the past 4 weeks or planned changes during the study
- Current involvement in litigation related to fibromyalgia or chronic pain
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt, 12311
Actively Recruiting
Research Team
M
Mohamed ElMeligie, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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