Evaluation of the Effect of Wet Cupping (Hijama) on Primary Fibromyalgia

NCT06320262 · tracked via the Priya Life Science Egypt tracker

Sponsor

Rasmia Elgohary

Phase

Not applicable

Started

2024-12-26

Last updated

2024-12-30

Condition(s) studied

Treatment

Investigational drug(s) / intervention(s)

Wet cupping therapy (WCT)

Wet cupping therapy (WCT): Type of cupping: Triple-stage wet cupping therapy (Hijama) will be used; sucking, scarification, sucking. Cupping points will include one cup on the posterior median line, in the depression below the processus spinosus of the 7th cervical vertebra (Alkahil area); two points in the inter-scapular region 3cm lateral to the lower border of the spinous process of the 3rd thoracic vertebra, two points at inferior angle of the scapula (3cm lateral to lower border of the spinous process of the 7th thoracic vertebra, 2 points at lumbar regions, in addition to the most painful areas. After the procedure: Areas of cupping will be covered using sterile gauze. All used tools and materials will be collected in red bags to ensure proper waste disposal. Sharp objects will be disposed of in the sharps disposal box. Telephone follow-up with all patients 48 hours after cupping will be done.

Study summary

Fibromyalgia has become one of the most prevalent chronic pain conditions that impair quality of life. Wet cupping has gained increasing popularity in treating painful conditions.

This study aims to investigate the effectiveness of wet cupping therapy combined with home-based exercise compared to home-based exercise alone in improving patients diagnosed with primary fibromyalgia syndrome.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

55 Years

Healthy volunteers

Inclusion Criteria: * Adult patients aged 18-55 years. * Female individuals to avoid the gender confounding factor. * Clinical diagnosis of primary fibromyalgia according to the 2016 American College of Rheumatology (ACR) updated diagnostic criteria. * Moderate pain intensity of ≥ 45 mm or higher on a visual analog scale (VAS). * No use of skeletal muscle relaxants, antidepressants, antiepileptic drugs, corticosteroids, benzodiazepines, and tramadol within a year before the screening visit. Exclusion Criteria: * Underlying rheumatic, malignant, metabolic, hematological, or neurological disorders. * Patients with bleeding disorders or receiving anticoagulants. * Previous use, within a year, or current use of skeletal muscle relaxants, antidepressants, antiepileptic drugs, corticosteroids, benzodiazepines, or tramadol * Patients with BMI ≤ 18 or ≥ 35. * Pregnant or lactating women. * Patients with severe anemia.

Primary outcome measure(s)

Change from baseline brain MRS — At the time of inclusion and at week 12
Voxel placement will be applied to study the following brain centers both thalami, insular regions, amygdalae, hippocampi, superior frontal gyri, and anterior cingulate gyri to determine the concentration of brain neurometabolites Nacetylaspartate (NAA), choline (Cho), and creatine (Cr) and their ratios.

Trial sites (1)

Facility	City	Region	Status
Rheumatology and Immunology out patient clinic, Internal Medicine Department, Cairo University	Cairo	Egypt	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06320262 on ClinicalTrials.gov ↗ ← All trials in Egypt