Actively Recruiting
Effect of Wet Cupping Therapy Combined with Home Exercise on Primary Fibromyalgia Using Brain Magnetic Resonance Spectroscopy and Patient Reports Randomized Controlled Clinical Trial
Led by Rasmia Elgohary · Updated on 2024-12-30
50
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Fibromyalgia is a common chronic pain condition that affects quality of life and includes symptoms like widespread pain, fatigue, sleep problems, and cognitive difficulties. There is no definitive treatment, and non-drug therapies are generally preferred as first-line options. This research aims to assess the effectiveness of wet cupping therapy combined with home-based exercise compared to home-based exercise alone in women diagnosed with primary fibromyalgia syndrome. The study will enroll 50 female patients aged 18 to 55 years diagnosed based on the American College of Rheumatology criteria. Participants will be randomly assigned to two groups: one will follow a home-based graded exercise program alone, while the other will receive triple-stage wet cupping therapy (Hijama) in addition to the exercise. The cupping therapy involves suction, skin scarification, and suction over specific points on the back, including areas near certain vertebrae and the most painful regions. After treatment, areas will be covered and waste properly disposed of, with telephone follow-up 48 hours after cupping. Participants will undergo brain magnetic resonance spectroscopy and various clinical assessments at the start and after 12 weeks. These include measures of pain intensity, fibromyalgia impact, sleep disturbance, fatigue, anxiety, depression, cognitive function, and blood tests. The main outcome is the change in brain magnetic resonance spectroscopy findings from baseline to week 12. Safety and adherence will be monitored throughout the study period.
CONDITIONS
Official Title
Evaluation of the Effect of Wet Cupping (Hijama) on Primary Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult female patients aged 18 to 55 years
- Diagnosed with primary fibromyalgia according to the 2016 American College of Rheumatology criteria
- Moderate pain intensity of 45 mm or higher on a visual analog scale
- No use of muscle relaxants, antidepressants, antiepileptic drugs, corticosteroids, benzodiazepines, or tramadol within one year before screening
You will not qualify if you...
- Presence of rheumatic, malignant, metabolic, hematological, or neurological disorders
- Patients with bleeding disorders or those receiving anticoagulant treatment
- Use of muscle relaxants, antidepressants, antiepileptic drugs, corticosteroids, benzodiazepines, or tramadol within one year before screening or currently
- Body mass index less than or equal to 18 or greater than or equal to 35
- Pregnant or breastfeeding women
- Patients with severe anemia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Rheumatology and Immunology out patient clinic, Internal Medicine Department, Cairo University
Cairo, Egypt
Actively Recruiting
Research Team
R
Rasmia M Elgohary, A. Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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