Evaluation of the Effect of Wet Cupping (Hijama) on Primary Fibromyalgia Using Brain Magnetic Resonance Spectroscopy and Patient-reported Forms: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline brain MRS
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 ≥
- •Pregnant or lactating women.
- •Patients with severe anemia.
研究组 & 干预措施
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.
Intervention group
They will receive wet cupping therapy (WCT) every month for 3 consecutive months in addition to a home-based graded exercise program.
干预措施: Wet cupping therapy (WCT) (Procedure)
结局指标
主要结局
Change from baseline brain MRS
时间窗: At the time of inclusion and at week 12
Voxel placement will be applied to study the following brain centers both thalami, insular regions, amygdalae, hippocampi, superior frontal gyri, and anterior cingulate gyri to determine the concentration of brain neurometabolites Nacetylaspartate (NAA), choline (Cho), and creatine (Cr) and their ratios.
次要结局
- Change from baseline hemoglobin(At the time of inclusion and at week 12)
- Change from baseline of the Widespread pain index (WPI)(At the time of inclusion and at week 12)
- Change from baseline of Hospital Anxiety and Depression Scale (HADS)(At the time of inclusion and at week 12)
- patient compliance on exercise as instructed(This diary will be reviewed at weeks 4, 8 and 12)
- Change from baseline in the individual components of the Fibromyalgia Impact Questionnaire Revised (FIQR)(At the time of inclusion and at week 12)
- Change from baseline Fatigue- VAS.(At the time of inclusion and at week 12)
- Change from baseline Visual Analog Scale (VAS)(At the time of inclusion and at week 12)
- Change from the baseline sleep disturbance using the Jenkins sleep score (JSS)(At the time of inclusion and at week 12)
- Change from baseline of the Montreal Cognitive Assessment (MoCA)(At the time of inclusion and at week 12)
研究者
Rasmia Elgohary
assistant professor
Cairo University