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

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.

• Change from baseline Visual Analog Scale (VAS) [Срок оценки: At the time of inclusion and at week 12]
• Change from baseline in the individual components of the Fibromyalgia Impact Questionnaire Revised (FIQR) [Срок оценки: At the time of inclusion and at week 12]
• Change from the baseline sleep disturbance using the Jenkins sleep score (JSS) [Срок оценки: At the time of inclusion and at week 12]
• Change from baseline Fatigue- VAS. [Срок оценки: At the time of inclusion and at week 12]
• Change from baseline of Hospital Anxiety and Depression Scale (HADS) [Срок оценки: At the time of inclusion and at week 12]
• Change from baseline of the Montreal Cognitive Assessment (MoCA) [Срок оценки: At the time of inclusion and at week 12]
• Change from baseline of the Widespread pain index (WPI) [Срок оценки: At the time of inclusion and at week 12]
• Change from baseline hemoglobin [Срок оценки: At the time of inclusion and at week 12]
• patient compliance on exercise as instructed [Срок оценки: This diary will be reviewed at weeks 4, 8 and 12]