Evaluation of the Effect of Wet Cupping (Hijama) on Primary Fibromyalgia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wet cupping therapy (WCT).
- Who it may be relevant to
- Registry conditions: Treatment. Basic parameters: 18 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effect of Wet Cupping (Hijama) on Primary Fibromyalgia Using Brain Magnetic Resonance Spectroscopy and Patient-reported Forms: Randomized Controlled Clinical Trial
Overview
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.
Detailed description
Background: The fibromyalgia (FM) syndrome is characterized by widespread chronic pain accompanied by fatigue, cognitive disturbances, sleep disorders, and pronounced somatic and/or psychological distress that impair the quality of life. So far there is no definitive treatment for FM. All available guidelines agreed on the first-line role of non-pharmacological therapies over pharmacological agents.
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.
Interventions
- Procedure 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 tho
Primary outcome measures
- Change from baseline brain MRS [Time frame: At the time of inclusion and at week 12]
Secondary outcome measures (9)
- Change from baseline Visual Analog Scale (VAS) [Time frame: At the time of inclusion and at week 12]
- Change from baseline in the individual components of the Fibromyalgia Impact Questionnaire Revised (FIQR) [Time frame: At the time of inclusion and at week 12]
- Change from the baseline sleep disturbance using the Jenkins sleep score (JSS) [Time frame: At the time of inclusion and at week 12]
- Change from baseline Fatigue- VAS. [Time frame: At the time of inclusion and at week 12]
- Change from baseline of Hospital Anxiety and Depression Scale (HADS) [Time frame: At the time of inclusion and at week 12]
- Change from baseline of the Montreal Cognitive Assessment (MoCA) [Time frame: At the time of inclusion and at week 12]
- Change from baseline of the Widespread pain index (WPI) [Time frame: At the time of inclusion and at week 12]
- Change from baseline hemoglobin [Time frame: At the time of inclusion and at week 12]
- patient compliance on exercise as instructed [Time frame: This diary will be reviewed at weeks 4, 8 and 12]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Rheumatology and Immunology out patient clinic, Internal Medicine Department, Cairo Univer — Cairo
Identifiers
NCT: NCT06320262 · NRC/TDF/01/F