Evaluation of the Effect of Wet Cupping (Hijama) on Primary Fibromyalgia
NCT ID: NCT06320262
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-12-26
2025-12-31
Brief Summary
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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.
Detailed Description
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Cupping therapy (Hijama in Arabic) is an ancient medical art that has been used primarily in the treatment of several painful conditions and has regained popularity in modern medicine.
Purpose: Our study aims to investigate the efficacy of wet cupping therapy in treating patients diagnosed with primary fibromyalgia.
Method: the study will include 50 female patients who had been diagnosed with fibromyalgia syndrome (FMS) according to the American College of Rheumatology (ACR) criteria and had symptoms not exceeding two years.
The eligible patients will further undergo Brain magnetic resonance spectroscopy and clinical assessment including evaluation of the following
1. Widespread pain index (WPI) and pain intensity using a Visual Analog Scale (VAS),
2. Total impact of FM as measured by the validated Arabic version of the Revised Fibromyalgia Impact Questionnaire (FIQR).
3. Evaluation of sleep disturbance using the Jenkins sleep score
4. Evaluation of fatigue using a horizontal line (VAS) anchored by "0=No fatigue " and "100=Worst imaginable fatigue
5. Evaluation of Depression and anxiety using the validated Arabic version of Hospital Anxiety and Depression Scale (HADS)
6. Cognitive function assessment using the Montreal Cognitive Assessment (MoCA)
7. Complete blood count
Randomization: All eligible patients will receive instructions on a home-based graded exercise program, then the patients will randomly be assigned into two groups
1. Control group: will be kept on home-based exercise alone
2. Intervention group: They will receive wet cupping therapy in addition to home-based exercise.
Follow-up assessments: at week 12 after initiating the therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group
They will receive wet cupping therapy (WCT) every month for 3 consecutive months in addition to a home-based graded exercise program.
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.
Control group
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.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
FEMALE
No
Sponsors
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Rasmia Elgohary
OTHER
Responsible Party
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Rasmia Elgohary
assistant professor
Principal Investigators
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Mohamed Yousef, Professor
Role: PRINCIPAL_INVESTIGATOR
Kasr Alainy School of Medicine, Cairo University, Egypt
Maha M Sabr, Professor
Role: PRINCIPAL_INVESTIGATOR
National Research Center (NRC)
Dalia B Abdelbaky, A. Prof.
Role: STUDY_CHAIR
National Cancer Institute (NCI)
Dalia M Afifi, Consultant
Role: STUDY_CHAIR
Agouza Rheumatology and Rehabilitation, Armed Forces, Egypt
Gehad G Maghraby, Lecturer
Role: STUDY_CHAIR
Kasr Alainy School of Medicine, Cairo University, Egypt
Locations
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Rheumatology and Immunology out patient clinic, Internal Medicine Department, Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Rasmia MH Elgohary
Role: primary
Other Identifiers
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NRC/TDF/01/F
Identifier Type: -
Identifier Source: org_study_id