Clinical trial NCT06320262: Evaluation of the Effect of Wet Cupping (Hijama) on Primary Fibromyalgia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Treatment
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled drugs
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Change from baseline brain MRS
timeFrame: At the time of inclusion and at week 12
Secondary outcomes:
measure: Change from baseline Visual Analog Scale (VAS)
timeFrame: At the time of inclusion and at week 12
measure: Change from baseline in the individual components of the Fibromyalgia Impact Questionnaire Revised (FIQR)
timeFrame: At the time of inclusion and at week 12
measure: Change from the baseline sleep disturbance using the Jenkins sleep score (JSS)
timeFrame: At the time of inclusion and at week 12
measure: Change from baseline Fatigue- VAS.
timeFrame: At the time of inclusion and at week 12
measure: Change from baseline of Hospital Anxiety and Depression Scale (HADS)
timeFrame: At the time of inclusion and at week 12
measure: Change from baseline of the Montreal Cognitive Assessment (MoCA)
timeFrame: At the time of inclusion and at week 12
measure: Change from baseline of the Widespread pain index (WPI)
timeFrame: At the time of inclusion and at week 12
measure: Change from baseline hemoglobin
timeFrame: At the time of inclusion and at week 12
measure: patient compliance on exercise as instructed
timeFrame: This diary will be reviewed at weeks 4, 8 and 12
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Rheumatology and Immunology out patient clinic, Internal Medicine Department, Cairo University
Study officials:
affiliation: Kasr Alainy School of Medicine, Cairo University, Egypt
name: Mohamed Yousef, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: National Research Center (NRC)
name: Maha M Sabr, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute (NCI)
name: Dalia B Abdelbaky, A. Prof.
role: STUDY_CHAIR
affiliation: Agouza Rheumatology and Rehabilitation, Armed Forces, Egypt
name: Dalia M Afifi, Consultant
role: STUDY_CHAIR
affiliation: Kasr Alainy School of Medicine, Cairo University, Egypt
name: Gehad G Maghraby, Lecturer
role: STUDY_CHAIR
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