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

NCT06320262 | Recruiting

• 1 other identifier: NRC/TDF/01/F
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Treatment

Outcome Measures

Primary Outcomes (1)

• Change from baseline brain MRS

  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.

  At the time of inclusion and at week 12

Secondary Outcomes (9)

• Change from baseline Visual Analog Scale (VAS)

  At the time of inclusion and at week 12

• Change from baseline in the individual components of the Fibromyalgia Impact Questionnaire Revised (FIQR)

  At the time of inclusion and at week 12

• Change from the baseline sleep disturbance using the Jenkins sleep score (JSS)

  At the time of inclusion and at week 12

• Change from baseline Fatigue- VAS.

  At the time of inclusion and at week 12

• Change from baseline of Hospital Anxiety and Depression Scale (HADS)

  At the time of inclusion and at week 12

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

They will receive wet cupping therapy (WCT) every month for 3 consecutive months in addition to a home-based graded exercise program.

Procedure: Wet cupping therapy (WCT)

Control group

NO INTERVENTION

they will receive a home-based graded exercise program, which is comprised of both aerobic and stretching exercises. The patients will be instructed to do the protocols with a gradual increase in both intensity and frequency.

Interventions

Wet cupping therapy (WCT) PROCEDURE

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.

Also known as: Hijama

Intervention group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: only female individuals will be included to avoid the gender confounding factor.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rasmia Elgohary: lead

Study Sites (1)

Rheumatology and Immunology out patient clinic, Internal Medicine Department, Cairo University

Cairo, Egypt

RECRUITING

Study Officials

• Mohamed Yousef, Professor

  Kasr Alainy School of Medicine, Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

• Maha M Sabr, Professor

  National Research Center (NRC)

  PRINCIPAL INVESTIGATOR

• Dalia B Abdelbaky, A. Prof.

  National Cancer Institute (NCI)

  STUDY CHAIR

• Dalia M Afifi, Consultant

  Agouza Rheumatology and Rehabilitation, Armed Forces, Egypt

  STUDY CHAIR

• Gehad G Maghraby, Lecturer

  Kasr Alainy School of Medicine, Cairo University, Egypt

  STUDY CHAIR

Central Study Contacts

Rasmia M Elgohary, A. Prof.

CONTACT

01111370118; rasmiaelgohary@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Model Details: Randomized controlled drugs

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 20, 2024
• Study Start: December 26, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)