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

Rasmia Elgohary

Status: Enrolling

Conditions: Treatment

Treatments: Procedure: Wet cupping therapy (WCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06320262

NRC/TDF/01/F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

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

Treatment:

Procedure: Wet cupping therapy (WCT)

Control group

No Intervention group

Description:

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.