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

Evaluation of the Effect of Wet Cupping (Hijama) on Primary Fibromyalgia Using Brain Magnetic Resonance Spectroscopy and Patient-reported Forms: Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Treatment
• Intervention / Treatment: Procedure: Wet cupping therapy (WCT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rasmia M Elgohary, A. Prof.; Phone Number: 01111370118; Email: rasmiaelgohary@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.
• The duration of the disease does not exceed two years.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; They will receive wet cupping therapy (WCT) every month for 3 consecutive months in addition to a home-based graded exercise program.	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 thoracic vertebra, 2 points at lumbar regions, in addition to the most painful areas. After the procedure: Areas of cupping will be covered using sterile gauze. All used tools and materials will be collected in red bags to ensure proper waste disposal. Sharp objects will be disposed of in the sharps disposal box. Telephone follow-up with all patients 48 hours after cupping will be done.; Other Names: Hijama
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline brain MRS	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.	At the time of inclusion and at week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Visual Analog Scale (VAS)	Evaluation of pain using a horizontal line (VAS) anchored by "0=No pain" and "100=Worst pain	At the time of inclusion and at week 12
Change from baseline in the individual components of the Fibromyalgia Impact Questionnaire Revised (FIQR)	the FIQR is a commonly used instrument in the evaluation of FM patients. It contains 21 questions in 3 domains: function (9 questions), overall impact (2 questions), and symptoms (10 questions), a validated Arabic version will be used.	At the time of inclusion and at week 12
Change from the baseline sleep disturbance using the Jenkins sleep score (JSS)	Jenkins sleep score (JSS) is a 4-item questionnaire to follow common sleep problems. The frequency of sleep problems in the last month is evaluated using four items: difficulty falling asleep, waking up at night, difficulty staying asleep, and non-restorative sleep (ie, waking up after the usual amount of sleep feeling tired and worn out). Each item is rated on a Likert-like scale from 0 to 5, where 0 is 'never', 1 is '1-3 days', 2 is 'about 1 night/week', 3 is '2-4 nights/week', 4 is '5-6 nights/week' and 5 is 'almost every night'. The total score is a simple sum of all four items' scores and ranges from 0 (no sleep problems) to 20 (most sleep problems). The score of 11 is a cut-off-a score <12 is defined as little sleep disturbances and a score >11 is understood as a high frequency of sleep disturbances.	At the time of inclusion and at week 12
Change from baseline Fatigue- VAS.	Evaluation of fatigue using a horizontal line (VAS) anchored by "0=No fatigue " and "100=Worst imaginable fatigue	At the time of inclusion and at week 12
Change from baseline of Hospital Anxiety and Depression Scale (HADS)	The Hospital Anxiety and Depression Scale (HADS) evaluates depression and anxiety, it produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D). Scores greater than or equal to 11 on either scale indicate a definitive case. A validated Arabic version will be used.	At the time of inclusion and at week 12
Change from baseline of the Montreal Cognitive Assessment (MoCA)	The Montreal Cognitive Assessment score examines seven domains (aspects) of cognitive function (executive/visuospatial function, naming, attention, language, abstraction, recall, and orientation). The maximum score is 30. the score is interpreted as follows; Normal cognition: 26-30 points, Mild cognitive impairment: 18-25 points, Moderate cognitive impairment: 10-17 points, Severe cognitive impairment: Under 10 points.	At the time of inclusion and at week 12
Change from baseline of the Widespread pain index (WPI)	The widespread pain index evaluates the number of painful areas out of a total of 19 areas, and the number is expected to decrease as the patient improves and vice versa.	At the time of inclusion and at week 12
Change from baseline hemoglobin	hemoglobin will be assessed in the complete blood count	At the time of inclusion and at week 12
patient compliance on exercise as instructed	All patients will be asked to complete activity diaries daily to assess adherence. Exercise adherence is considered when the patient can participate in 80% of the prescribed exercise sessions.	This diary will be reviewed at weeks 4, 8 and 12

Collaborators and Investigators

• Sponsor: Rasmia Elgohary
• Investigators: Principal Investigator: Mohamed Yousef, Professor, Kasr Alainy School of Medicine, Cairo University, Egypt; Principal Investigator: Maha M Sabr, Professor, National Research Center (NRC); Study Chair: Dalia B Abdelbaky, A. Prof., National Cancer Institute (NCI); Study Chair: Dalia M Afifi, Consultant, Agouza Rheumatology and Rehabilitation, Armed Forces, Egypt; Study Chair: Gehad G Maghraby, Lecturer, Kasr Alainy School of Medicine, Cairo University, Egypt

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 16, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia
• Other Study ID Numbers: NRC/TDF/01/F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No