Migraine-related HeadacheNCT06568757
The Effect of Wet Cupping Therapy on Headache and Migraine-related Disability
A study testing Wet Cupping in people with Migraine-related Headache, run by Mersin University.
Trial summary
Objective: This study aims to investigate the effects of wet cupping therapy (cupping) applied once to the head and neck region on the severity of headache and disability in patients diagnosed with migraine. Method: The research will be conducted as a pre-test-post-test, randomized controlled and qualitative study. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Migraine-related Headache
- What is being tested?
- Wet Cupping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2024to 17 Mar 2025
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Those between the ages of 18-65,
- Those who are literate, speak Turkish and have no communication problems,
- Those diagnosed with migraine according to the International Classification of Headache Disorders (ICHD-3),
- Those who have had headaches for the last three months and are receiving medical treatment for this reason,
- Those who want to have cupping therapy,
- Those who do not have any bleeding or coagulation disorders,
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- Those who have not had wet cupping therapy in the last three months,
- Those who have a contraindication for wet cupping therapy (e.g. hemoglobin values below 9.5 gr/dl, INR below 1.5),
- Those who do not have a history of malignancy,
- Those who do not have an open wound in the application area,
- Those who do not have any psychiatric disorders
Who cannot join
- Patients with any incurable disease,
- Patients with a physical disability in the area where the application will be made,
- Patients with any skin disease in the area where the application will be made,
- Patients with large scar tissue in the area where the application will be made,
- Patients with a history of physical trauma in the area where the application will be made in the last three months,
- Patients with any peripheral vascular disease in the area where the application will be made,
- Patients who have used any complementary and integrative health application in the last three months,
- Patients who have received pain blockade treatment in the last year
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Wet Cupping Therapy on Headache Severity and Disability in Patients Diagnosed With Migraine
Objective: This study aims to investigate the effects of wet cupping therapy (cupping) applied once to the head and neck region on the severity of headache and disability in patients diagnosed with migraine.
Method: The research will be conducted as a pre-test-post-test, randomized controlled and qualitative study. Participants in the wet cupping group will receive wet cupping therapy using disposable plastic vacuum cups in a total of 4 regions including the cervical spine C7 (DU14 acupuncture point), bilateral T2-4 lateral spine (BL41-42 acupuncture point) and the suboccipital region (FengFu DU-16 acupuncture point). No intervention other than medical treatment will be applied to the control group. Patients in both groups will continue their routine treatments throughout the study. Before the intervention, the Patient Introduction Form, Wet Cupping Therapy Patient Feedback Form (pre-intervention) and Migraine Disability Assessment Scale (MIDAS) will be filled out. One month after the intervention, the Wet Cupping Therapy Patient Opinion Form (post-intervention) and the MIDAS will be re-evaluated after 3 months.
Results: Statistical analyses of the data will be performed using the Statistical Package for Social Sciences (Version 22.0, SPSS Inc., Chicago, IL, USA, License: Hitit University). Depending on the homogeneity of the data distribution, appropriate parametric or non-parametric tests will be applied for data evaluation.
Read the detailed description
The cupping application, which has a very old history and varies in different countries and cultures, is preferred especially in Islamic geography as wet cupping application and in Far Eastern countries as dry cupping application. In dry cupping application, the cup material (plastic, glass, bamboo) is attached to the application area by creating negative pressure and the skin is swollen. Blood collection is not performed in this application. In wet cupping application, the application is started with dry cupping application and then superficial incisions are made on the skin in order to drain the blood from the skin and the cup is closed again. When some interstitial fluid is observed, the application is terminated. Although the mechanism of action of wet cupping application has not been fully explained, it is stated that it has neural, hematological, immunological, metabolic and psychological effects. In addition, all the effects of cupping are interrelated and neural effect is explained by the gate control theory.
Cupping application is added to the treatment of many diseases that affect different systems, especially hypertension, low back pain, hyperlipidemia. Migraine is one of these diseases.
Migraine, a chronic neurovascular disorder, is a disease characterized by moderate to severe headache attacks typically accompanied by nausea, vomiting, photophobia or phonophobia. Migraine, which ranks second among the diseases that cause disability worldwide, negatively affects the quality of life of individuals. In addition, migraine, which creates a great socioeconomic burden, is the most common disability-causing disorder in young women. Therefore, acute and prophylactic treatments for migraine are gaining importance in terms of improving the quality of life and reducing the burden. Although pharmacological treatment guidelines for migraine have been developed and updated, limitations arise due to excessive use, resistance and side effects in drug treatment. For this reason, many complementary and integrative treatment methods such as mindfulness meditation, yoga, tai chi, chiropractic, acupuncture, massage, phytotherapy, homeopathy, bloodletting and cupping are used in migraine treatment. There are a limited number of studies in the literature where cupping is applied in migraine treatment and its effect on pain intensity is evaluated. While all the study results found that cupping therapy reduces pain intensity, two studies found that it also reduces disability in addition to this result. According to the meta-analysis results of Seo et al. (2021), which included 6 randomized controlled trials (RCTs) from 218 studies, it was determined that cupping therapy reduces pain intensity and can significantly increase quality of life. However, it is stated that better designed RCTs are needed due to the low quality of evidence. Therefore, this study, which was planned to create evidence-based data for the literature, aims to examine the effect of cupping therapy on migraine-related disability and pain intensity.
- Conditions
- Migraine-related Headache
- Being tested
- Wet Cupping, No intervention
- Keywords
- wet cupping, migraine, headache, disability
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wet CuppingOther
Wet cupping therapy will be applied once using disposable plastic vacuum cups to a total of 4 areas, which are recommended areas for headaches; cervical spine C7 (DU14 acupuncture point), bilateral T2-4 lateral spine (BL41-42 acupuncture point) and suboccipital region (FengFu DU-16 acupuncture point).
No interventionOther
No treatment will be applied to individuals and the routine medical treatment program will continue.
| Study group | Role | What they receive |
|---|---|---|
| Wet Cupping Group | Experimental | The group that will receive wet cupping therapy-cupping application to the head and neck area in addition to medical treatment Receives: Other: Wet Cupping |
| Control Group | Active comparator | The group that will not receive any treatment other than medical treatment Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wet Cupping Therapy Patient Opinion Form (Pre-Intervention)
It includes open-ended questions created by the researcher about how the patient's migraine headache affects his/her life and whether he/she believes in the effect of wet cupping in reducing pain.
Measured: Day 1
Migraine Disability Assessment Scale (MIDAS)
It consists of 7 questions, the 1st, 3rd and 5th questions of which assess the days lost from school, work, housework or leisure activities due to headache in the last 3 months. The total MIDAS score is obtained by summing the first 5 questions. The total score is interpreted as 0-5 points as grade 1 (little or no restrictions), 6-10 points as grade 2 (mild or occasional restrictions), 11-20 points as grade 3 (moderate restrictions) and 21 or more points as grade 4 (severe restrictions).
Measured: Day 1
Secondary outcomes (2)
Wet Cupping Therapy Patient Opinion Form (Post-Intervention)
It is a form created by the researcher and includes the questions, "Did wet cupping therapy reduce the intensity and frequency of pain?, What are the easy and difficult aspects of wet cupping therapy?, Were there any side effects of wet cupping therapy?"
Measured: 1 months later
Migraine Disability Assessment Scale (MIDAS)
It consists of 7 questions, the 1st, 3rd and 5th questions of which assess the days lost from school, work, housework or leisure activities due to headache in the last 3 months. The total MIDAS score is obtained by summing the first 5 questions. The total score is interpreted as 0-5 points as grade 1 (little or no restrictions), 6-10 points as grade 2 (mild or occasional restrictions), 11-20 points as grade 3 (moderate restrictions) and 21 or more points as grade 4 (severe restrictions).
Measured: 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start23 Sep 2024 (estimated)
- Primary completion24 Oct 2024 (estimated)
- Study completion17 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine-related HeadacheStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan ÇEÇEN, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568757
- Sponsor's protocol ID
- Wet Cupping Therapy
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdulah DM, Mohammedsadiq HA, Mohammed AH. Effectiveness of wet cupping therapy on relieving pain in patients with chronic migraine: an observational study. J Complement Integr Med. 2021 Apr 1;18(3):569-577. doi: 10.1515/jcim-2020-0183.
PubMed 33793142
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Wet Cupping Therapy on Headache Severity and Disability in Patients Diagnosed With Migraine
- ClinicalTrials.gov ID
- NCT06568757
- Acronym / sponsor ID
- Wet Cupping Therapy
- Conditions
- Migraine-related Headache
- Keywords
- wet cupping, migraine, headache, disability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 23 Sep 2024 (estimated)
- Primary completion
- 24 Oct 2024 (estimated)
- Study completion
- 17 Mar 2025 (estimated)
- First posted
- 23 Aug 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.
Objective: This study aims to investigate the effects of wet cupping therapy (cupping) applied once to the head and neck region on the severity of headache and disability in patients diagnosed with migraine.
Method: The research will be conducted as a pre-test-post-test, randomized controlled and qualitative study. Participants in the wet cupping group will receive wet cupping therapy using disposable plastic vacuum cups in a total of 4 regions including the cervical spine C7 (DU14 acupuncture point), bilateral T2-4 lateral spine (BL41-42 acupuncture point) and the suboccipital region (FengFu DU-16 acupuncture point). No intervention other than medical treatment will be applied to the control group. Patients in both groups will continue their routine treatments throughout the study. Before the intervention, the Patient Introduction Form, Wet Cupping Therapy Patient Feedback Form (pre-intervention) and Migraine Disability Assessment Scale (MIDAS) will be filled out. One month after the intervention, the Wet Cupping Therapy Patient Opinion Form (post-intervention) and the MIDAS will be re-evaluated after 3 months.
Results: Statistical analyses of the data will be performed using the Statistical Package for Social Sciences (Version 22.0, SPSS Inc., Chicago, IL, USA, License: Hitit University). Depending on the homogeneity of the data distribution, appropriate parametric or non-parametric tests will be applied for data evaluation.
Detailed description
The cupping application, which has a very old history and varies in different countries and cultures, is preferred especially in Islamic geography as wet cupping application and in Far Eastern countries as dry cupping application. In dry cupping application, the cup material (plastic, glass, bamboo) is attached to the application area by creating negative pressure and the skin is swollen. Blood collection is not performed in this application. In wet cupping application, the application is started with dry cupping application and then superficial incisions are made on the skin in order to drain the blood from the skin and the cup is closed again. When some interstitial fluid is observed, the application is terminated. Although the mechanism of action of wet cupping application has not been fully explained, it is stated that it has neural, hematological, immunological, metabolic and psychological effects. In addition, all the effects of cupping are interrelated and neural effect is explained by the gate control theory.
Cupping application is added to the treatment of many diseases that affect different systems, especially hypertension, low back pain, hyperlipidemia. Migraine is one of these diseases.
Migraine, a chronic neurovascular disorder, is a disease characterized by moderate to severe headache attacks typically accompanied by nausea, vomiting, photophobia or phonophobia. Migraine, which ranks second among the diseases that cause disability worldwide, negatively affects the quality of life of individuals. In addition, migraine, which creates a great socioeconomic burden, is the most common disability-causing disorder in young women. Therefore, acute and prophylactic treatments for migraine are gaining importance in terms of improving the quality of life and reducing the burden. Although pharmacological treatment guidelines for migraine have been developed and updated, limitations arise due to excessive use, resistance and side effects in drug treatment. For this reason, many complementary and integrative treatment methods such as mindfulness meditation, yoga, tai chi, chiropractic, acupuncture, massage, phytotherapy, homeopathy, bloodletting and cupping are used in migraine treatment. There are a limited number of studies in the literature where cupping is applied in migraine treatment and its effect on pain intensity is evaluated. While all the study results found that cupping therapy reduces pain intensity, two studies found that it also reduces disability in addition to this result. According to the meta-analysis results of Seo et al. (2021), which included 6 randomized controlled trials (RCTs) from 218 studies, it was determined that cupping therapy reduces pain intensity and can significantly increase quality of life. However, it is stated that better designed RCTs are needed due to the low quality of evidence. Therefore, this study, which was planned to create evidence-based data for the literature, aims to examine the effect of cupping therapy on migraine-related disability and pain intensity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wet Cupping Group | Experimental | Other: Wet CuppingThe group that will receive wet cupping therapy-cupping application to the head and neck area in addition to medical treatment |
| Control Group | Active comparator | Other: No interventionThe group that will not receive any treatment other than medical treatment |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Those between the ages of 18-65,
- Those who are literate, speak Turkish and have no communication problems,
- Those diagnosed with migraine according to the International Classification of Headache Disorders (ICHD-3),
- Those who have had headaches for the last three months and are receiving medical treatment for this reason,
- Those who want to have cupping therapy,
Key exclusion criteria (8 listed)
- Patients with any incurable disease,
- Patients with a physical disability in the area where the application will be made,
- Patients with any skin disease in the area where the application will be made,
- Patients with large scar tissue in the area where the application will be made,
- Patients with a history of physical trauma in the area where the application will be made in the last three months,
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 CuppingWet cupping therapy will be applied once using disposable plastic vacuum cups to a total of 4 areas, which are recommended areas for headaches; cervical spine C7 (DU14 acupuncture point), bilateral T2-4 lateral spine (BL41-42 acupuncture point) and suboccipital region (FengFu DU-16 acupuncture point). | Other | Wet Cupping Group |
| No interventionNo treatment will be applied to individuals and the routine medical treatment program will continue. | Other | Control Group |
Primary outcome
Wet Cupping Therapy Patient Opinion Form (Pre-Intervention)
Time frame: Day 1
It includes open-ended questions created by the researcher about how the patient's migraine headache affects his/her life and whether he/she believes in the effect of wet cupping in reducing pain.
Migraine Disability Assessment Scale (MIDAS)
Time frame: Day 1
It consists of 7 questions, the 1st, 3rd and 5th questions of which assess the days lost from school, work, housework or leisure activities due to headache in the last 3 months. The total MIDAS score is obtained by summing the first 5 questions. The total score is interpreted as 0-5 points as grade 1 (little or no restrictions), 6-10 points as grade 2 (mild or occasional restrictions), 11-20 points as grade 3 (moderate restrictions) and 21 or more points as grade 4 (severe restrictions).
2 secondary outcomes
Wet Cupping Therapy Patient Opinion Form (Post-Intervention)
Time frame: 1 months later
Migraine Disability Assessment Scale (MIDAS)
Time frame: 3 months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Background: PubMed 33793142Abdulah DM, Mohammedsadiq HA, Mohammed AH. Effectiveness of wet cupping therapy on relieving pain in patients with chronic migraine: an observational study. J Complement Integr Med. 2021 Apr 1;18(3):569-577. doi: 10.1515/jcim-2020-0183.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Wet Cupping in people with Migraine-related Headache, run by Mersin University.
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 11 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sultan Çeçen (+90 364 2231561 ext. 3006, sultancecen@hitit.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wet Cupping Therapy Patient Opinion Form (Pre-Intervention) (time frame: Day 1). 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?
On the ClinicalTrials.gov record for NCT06568757, which also lists 1 linked publication.
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 23 Aug 2024.