TreatmentNCT06320262
Evaluation of the Effect of Wet Cupping (Hijama) on Primary Fibromyalgia
A study testing Wet cupping therapy (WCT) in people with Treatment, run by Rasmia Elgohary at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Treatment
- What is being tested?
- Wet cupping therapy (WCT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Dec 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Rheumatology and Immunology out patient clinic, Internal Medicine Department, Cairo University
Cairo
Rasmia MH Elgohary, 01111370118, rasmiaelgohary@kasralainy.edu.eg
About this study
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
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.
Read the 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
- Widespread pain index (WPI) and pain intensity using a Visual Analog Scale (VAS),
- Total impact of FM as measured by the validated Arabic version of the Revised Fibromyalgia Impact Questionnaire (FIQR).
- Evaluation of sleep disturbance using the Jenkins sleep score
- Evaluation of fatigue using a horizontal line (VAS) anchored by "0=No fatigue " and "100=Worst imaginable fatigue
- Evaluation of Depression and anxiety using the validated Arabic version of Hospital Anxiety and Depression Scale (HADS)
- Cognitive function assessment using the Montreal Cognitive Assessment (MoCA)
- 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
- Control group: will be kept on home-based exercise alone
- Intervention group: They will receive wet cupping therapy in addition to home-based exercise.
Follow-up assessments: at week 12 after initiating the therapy.
- Conditions
- Treatment
- Being tested
- Wet cupping therapy (WCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wet cupping therapy (WCT)Procedure or surgery
Also called Hijama
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | They will receive wet cupping therapy (WCT) every month for 3 consecutive months in addition to a home-based graded exercise program. Receives: Procedure: Wet cupping therapy (WCT) |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of inclusion and at week 12
Secondary outcomes (9)
Change from baseline Visual Analog Scale (VAS)
Evaluation of pain using a horizontal line (VAS) anchored by "0=No pain" and "100=Worst pain
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the time of inclusion and at week 12
Change from baseline hemoglobin
hemoglobin will be assessed in the complete blood count
Measured: 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.
Measured: This diary will be reviewed at weeks 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start26 Dec 2024
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled drugs
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rasmia Elgohary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rasmia Elgohary, Cairo University
- Investigators
- Mohamed Yousef, Professor, Principal investigator, Kasr Alainy School of Medicine, Cairo University, EgyptMaha M Sabr, Professor, Principal investigator, National Research Center (NRC)Dalia B Abdelbaky, A. Prof., Study chair, National Cancer Institute (NCI)Dalia M Afifi, Consultant, Study chair, Agouza Rheumatology and Rehabilitation, Armed Forces, EgyptGehad G Maghraby, Lecturer, Study chair, Kasr Alainy School of Medicine, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320262
- Sponsor's protocol ID
- NRC/TDF/01/F
- Status last verified
- Dec 2024
- First submitted
- 29 Feb 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06320262
- Acronym / sponsor ID
- NRC/TDF/01/F
- Conditions
- Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rasmia ElgoharyUniversity, hospital or other
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Widespread pain index (WPI) and pain intensity using a Visual Analog Scale (VAS),
- Total impact of FM as measured by the validated Arabic version of the Revised Fibromyalgia Impact Questionnaire (FIQR).
- Evaluation of sleep disturbance using the Jenkins sleep score
- Evaluation of fatigue using a horizontal line (VAS) anchored by "0=No fatigue " and "100=Worst imaginable fatigue
- Evaluation of Depression and anxiety using the validated Arabic version of Hospital Anxiety and Depression Scale (HADS)
- Cognitive function assessment using the Montreal Cognitive Assessment (MoCA)
- 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
- Control group: will be kept on home-based exercise alone
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled drugs
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Procedure: Wet cupping therapy (WCT)They will receive wet cupping therapy (WCT) every month for 3 consecutive months in addition to a home-based graded exercise program. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wet cupping therapy (WCT)Also: HijamaType 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. | Procedure or surgery | Intervention group |
Primary outcome
Change from baseline brain MRS
Time frame: 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.
9 secondary outcomes
Change from baseline Visual Analog Scale (VAS)
Time frame: At the time of inclusion and at week 12
Change from baseline in the individual components of the Fibromyalgia Impact Questionnaire Revised (FIQR)
Time frame: At the time of inclusion and at week 12
Change from the baseline sleep disturbance using the Jenkins sleep score (JSS)
Time frame: At the time of inclusion and at week 12
Change from baseline Fatigue- VAS.
Time frame: At the time of inclusion and at week 12
Change from baseline of Hospital Anxiety and Depression Scale (HADS)
Time frame: At the time of inclusion and at week 12
Change from baseline of the Montreal Cognitive Assessment (MoCA)
Time frame: At the time of inclusion and at week 12
Change from baseline of the Widespread pain index (WPI)
Time frame: At the time of inclusion and at week 12
Change from baseline hemoglobin
Time frame: At the time of inclusion and at week 12
patient compliance on exercise as instructed
Time frame: This diary will be reviewed at weeks 4, 8 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Yousef, Professor principal investigator
Kasr Alainy School of Medicine, Cairo University, Egypt
Maha M Sabr, Professor principal investigator
National Research Center (NRC)
Dalia B Abdelbaky, A. Prof. study chair
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wet cupping therapy (WCT) in people with Treatment, run by Rasmia Elgohary at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rasmia M Elgohary, A. Prof. (01111370118, rasmiaelgohary@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline brain MRS (time frame: At the time of inclusion and at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.