MigraineNCT05282134
Comparison of Wet Cupping and Acupuncture in Migraine
A study testing Wet cupping therapy and Acupuncture in people with Migraine, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of wet cupping therapy (WCT) on migraine patients and compare it with acupuncture. The patients will be randomized into three groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Wet cupping therapy and Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18-65 who were diagnosed with migraine, no concomitant chronic disease and who gave their consent to participate in the study will be recruited.
Who cannot join
- 1. Having a bleeding diathesis
- 2. Receiving antithrombotic and antiaggregant therapy
- 3. Chronic disease that requires continuous drug use have
- 4. Wet cupping or hirudotherapy treatment in the last 3 months to have received 5.Be younger than 18 years old and over 65 years old 6. Having a hemoglobin value below 9.5 g/dl 7. INR value over 1.5
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Umraniye Training and Research Hospital
Istanbul, İ̇stanbul, 34070
About this study
Official title: Comparison of the Effectiveness of Wet Cupping and Acupuncture in Migraine: A Randomized Controlled Study
The aim of this study is to evaluate the effects of wet cupping therapy (WCT) on migraine patients and compare it with acupuncture. The patients will be randomized into three groups. WCT will be applied once a month to patients in group 1 and acupuncture will be applied to group 2, while the control group (group 3) will be on standard therapy for migraine. An evaluation will be made before treatment and at the 3rd month using the MIDAS and VAS.
Read the detailed description
Background: The most common primary headache is migraine. Migraine was ranked as the sixth cause of years lost due to disability all over the world in 2013. . About 15% of the world's population has migraine. Every year, 14-35% of women and 6-15% of men have migraine. The economic burden caused by the disease, which is so common and affects new masses every year, is substantial, as well as the loss of workforce, treatment costs. According to the UK-NHS data; Migraines cause an economic burden of 2.25 billion pounds based on 25 million lost days each year and more than 150 million pounds based on care, examinations, and treatment. There may be some side effects, drug interactions, comorbid conditions, and resistance cases in pharmacological treatments. In this context, traditional treatment methods may be preferred due to the low incidence of side effects. . In this context, traditional treatment methods may be preferred due to the low incidence of side effects. Acupuncture, which is widely used among traditional methods, has been shown to reduce the frequency of headaches. There are few studies on the effectiveness of Hijama, which is another traditional method and frequently used in our geography,
Purpose: The aim of the study is to investigate and compare the efficacy of wet cupping and acupuncture therapies in patients with migraine
Method: The patients who were referred to Umraniye Training Hospital Neurology polyclinic and diagnosed with migraine will be enrolled in the study.
The inclusion criteria are being 18-65 years old, having been diagnosed with migraine (ICHD-3 diagnosis criteria), and consenting to participate in the study. Those who are accompanied with any chronic disease and on daily medication, contraindicated to WCT as determined in the routine blood tests that were routinely performed before the prior to application (Hgb <9,5; INR> 1,2,; Hgb <9,5, etc) and who received WCT in the last three months will be excluded.
The volunteers will be randomized into three separate groups as wet cupping, acupuncture, and control group Control group will not receive any intervention. The wet cupping group will undergo 3 successive WCT sessions once in a month throughout 3 months (On 0, 30, and 60 days). Vacuum cups will be used on different acupuncture points to perform WCT: The one on the posterior median line, in the depression below the processus spinosus of the 7th cervical vertebra, was DU 14 (Dazhui) point; the ones on the back, 3.0 cm lateral to the lower border of the spinous process of the 3rd thoracic vertebra interscapulum region were UB 42 (Pohu) bilateral points; and the ones on the back, 3.0 cm lateral to the lower border of the spinous process of the 7th thoracic vertebra were UB 46 (Geguan) bilateral points and additionally the patient's trigger points which we detect during the examination. There will be 5-7 points in total. The technique used will be triple S (Sucking, Scarification, Sucking) in all sessions.
The acupuncture group will receive acupuncture application which will be done by manually needling on selected acupuncture points specific to the disease twice a week for 4 weeks. After the needles are placed, they will be manipulated to create a feeling of de-qi and will be left for 20 minutes.
At 0 and 3 months, MIDAS and VAS questionnaires will be applied to all patient groups Evaluation and comparison between the groups will be made with the scores of these questionnaires.
- Conditions
- Migraine
- Being tested
- Wet cupping therapy, Acupuncture
- Keywords
- Migrain, Wet Cupping, Acupuncture, VAS, MIDAS
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wet cupping therapyProcedure or surgery
Also called Hijama
Wet cupping therapy is a bloodletting application done by cups on the skin
AcupunctureProcedure or surgery
Acupuncture is a complementary application of TCM done by needles
| Study group | Role | What they receive |
|---|---|---|
| Wet cupping therapy | Experimental | The intervention group will undergo 3 successive wet cupping therapy (WCT) sessions once in a month throughout 3 months (On 0, 30, and 60 days. Cups will be held for 5 minutes on the 5 regions of the C7 cervical spine (DU14 acupuncture point), bilateral T2-4 lateral spine (BL41-42 acupoint) and bilateral T6-8 lateral spine (BL44-46) points, which are recommended areas for headache, Then, these areas where the blood supply has increased will be drawn with a sterile lancet and the cup will be applied again and left for 10 minutes, and then the cups will be removed and the accumulated blood will be cleaned. Receives: Procedure: Wet cupping therapy |
| Acupuncture | Experimental | Acupuncture application will be done by manually needling selected acupuncture points specific to the disease twice a week for 4 weeks. After the needles are placed, they will be manipulated to create a feeling of de-qi and left for 20 minutes. Receives: Procedure: Acupuncture |
| Control | No intervention | Control group will not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from the baseline (at 0 month) MIDAS scores at 3th month
The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self-administered questionnaire designed to quantify headache-related disability over a 3 month period.
Measured: At 0 and 3 months
The change from the baseline (at 0 month) VAS scores at 3 th month
Visual analogue scales (VAS) are well-validated instruments for assessing pain intensity. Scores are recorded by a mark on a 10-cm line that represents 0 as "no pain" and 10 as "worst pain."
Measured: At 0 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Jan 2022
- Primary completion5 Aug 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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 Trial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SULEYMAN ERSOY, Karabuk University
- Investigators
- Emin Pala, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282134
- Sponsor's protocol ID
- WCTACCU1
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Wet Cupping and Acupuncture in Migraine: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05282134
- Acronym / sponsor ID
- WCTACCU1
- Conditions
- Migraine
- Keywords
- Migrain, Wet Cupping, Acupuncture, VAS, MIDAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 16 Mar 2022 (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.
The aim of this study is to evaluate the effects of wet cupping therapy (WCT) on migraine patients and compare it with acupuncture. The patients will be randomized into three groups. WCT will be applied once a month to patients in group 1 and acupuncture will be applied to group 2, while the control group (group 3) will be on standard therapy for migraine. An evaluation will be made before treatment and at the 3rd month using the MIDAS and VAS.
Detailed description
Background: The most common primary headache is migraine. Migraine was ranked as the sixth cause of years lost due to disability all over the world in 2013. . About 15% of the world's population has migraine. Every year, 14-35% of women and 6-15% of men have migraine. The economic burden caused by the disease, which is so common and affects new masses every year, is substantial, as well as the loss of workforce, treatment costs. According to the UK-NHS data; Migraines cause an economic burden of 2.25 billion pounds based on 25 million lost days each year and more than 150 million pounds based on care, examinations, and treatment. There may be some side effects, drug interactions, comorbid conditions, and resistance cases in pharmacological treatments. In this context, traditional treatment methods may be preferred due to the low incidence of side effects. . In this context, traditional treatment methods may be preferred due to the low incidence of side effects. Acupuncture, which is widely used among traditional methods, has been shown to reduce the frequency of headaches. There are few studies on the effectiveness of Hijama, which is another traditional method and frequently used in our geography,
Purpose: The aim of the study is to investigate and compare the efficacy of wet cupping and acupuncture therapies in patients with migraine
Method: The patients who were referred to Umraniye Training Hospital Neurology polyclinic and diagnosed with migraine will be enrolled in the study.
The inclusion criteria are being 18-65 years old, having been diagnosed with migraine (ICHD-3 diagnosis criteria), and consenting to participate in the study. Those who are accompanied with any chronic disease and on daily medication, contraindicated to WCT as determined in the routine blood tests that were routinely performed before the prior to application (Hgb <9,5; INR> 1,2,; Hgb <9,5, etc) and who received WCT in the last three months will be excluded.
The volunteers will be randomized into three separate groups as wet cupping, acupuncture, and control group Control group will not receive any intervention. The wet cupping group will undergo 3 successive WCT sessions once in a month throughout 3 months (On 0, 30, and 60 days). Vacuum cups will be used on different acupuncture points to perform WCT: The one on the posterior median line, in the depression below the processus spinosus of the 7th cervical vertebra, was DU 14 (Dazhui) point; the ones on the back, 3.0 cm lateral to the lower border of the spinous process of the 3rd thoracic vertebra interscapulum region were UB 42 (Pohu) bilateral points; and the ones on the back, 3.0 cm lateral to the lower border of the spinous process of the 7th thoracic vertebra were UB 46 (Geguan) bilateral points and additionally the patient's trigger points which we detect during the examination. There will be 5-7 points in total. The technique used will be triple S (Sucking, Scarification, Sucking) in all sessions.
The acupuncture group will receive acupuncture application which will be done by manually needling on selected acupuncture points specific to the disease twice a week for 4 weeks. After the needles are placed, they will be manipulated to create a feeling of de-qi and will be left for 20 minutes.
At 0 and 3 months, MIDAS and VAS questionnaires will be applied to all patient groups Evaluation and comparison between the groups will be made with the scores of these questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Wet cupping therapy | Experimental | Procedure: Wet cupping therapyThe intervention group will undergo 3 successive wet cupping therapy (WCT) sessions once in a month throughout 3 months (On 0, 30, and 60 days. Cups will be held for 5 minutes on the 5 regions of the C7 cervical spine (DU14 acupuncture point), bilateral T2-4 lateral spine (BL41-42 acupoint) and bilateral T6-8 lateral spine (BL44-46) points, which are recommended areas for headache, Then, these areas where the blood supply has increased will be drawn with a sterile lancet and the cup will be applied again and left for 10 minutes, and then the cups will be removed and the accumulated blood will be cleaned. |
| Acupuncture | Experimental | Procedure: AcupunctureAcupuncture application will be done by manually needling selected acupuncture points specific to the disease twice a week for 4 weeks. After the needles are placed, they will be manipulated to create a feeling of de-qi and left for 20 minutes. |
| Control | No intervention | –Control group will not receive any intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between the ages of 18-65 who were diagnosed with migraine, no concomitant chronic disease and who gave their consent to participate in the study will be recruited.
Key exclusion criteria (4 listed)
- 1. Having a bleeding diathesis
- 2. Receiving antithrombotic and antiaggregant therapy
- 3. Chronic disease that requires continuous drug use have
- 4. Wet cupping or hirudotherapy treatment in the last 3 months to have received 5.Be younger than 18 years old and over 65 years old 6. Having a hemoglobin value below 9.5 g/dl 7. INR value over 1.5
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 therapyAlso: HijamaWet cupping therapy is a bloodletting application done by cups on the skin | Procedure or surgery | Wet cupping therapy |
| AcupunctureAcupuncture is a complementary application of TCM done by needles | Procedure or surgery | Acupuncture |
Primary outcome
The change from the baseline (at 0 month) MIDAS scores at 3th month
Time frame: At 0 and 3 months
The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self-administered questionnaire designed to quantify headache-related disability over a 3 month period.
The change from the baseline (at 0 month) VAS scores at 3 th month
Time frame: At 0 and 3 months
Visual analogue scales (VAS) are well-validated instruments for assessing pain intensity. Scores are recorded by a mark on a 10-cm line that represents 0 as "no pain" and 10 as "worst pain."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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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. This study is not recruiting at the moment.
Emin Pala study chair
Saglik Bilimleri Universitesi
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 and Acupuncture in people with Migraine, run by Karabuk University at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 26 Mar 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from the baseline (at 0 month) MIDAS scores at 3th month (time frame: At 0 and 3 months). The study lists 2 primary outcomes in all. 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 26 Mar 2024.