Migraine DisordersNCT03479060
Continue or Stop Applying Wet Cupping (Al-Hijamah) in Migraine
A study testing Wet Cupping in people with Migraine Disorders and Migraine With Aura, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the short and long-term effects of application of Wet Cupping Therapy (WCT) in the treatment of migraine headaches in adults.Half of the participants will continue WCT application and the other half will not. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine Disorders, Migraine With Aura, Migraine Without Aura
- What is being tested?
- Wet Cupping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2017to 1 Mar 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- History of head and neck surgery, Diagnosis of sinusitis Diagnosis of fibromyalgia and inflammatory disease (rheumatism, infection etc.) Diagnosis of cancer Diagnosis of bleeding disorder Malignant hypertension
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabuk University Karabuk Research and Education hospital
Karabük, Karabük Province, 78070
About this study
Official title: Continue or Stop Applying Wet Cupping (Al-Hijamah) in Migraine Headache: A Randomized Control Trial
This study evaluates the short and long-term effects of application of Wet Cupping Therapy (WCT) in the treatment of migraine headaches in adults.Half of the participants will continue WCT application and the other half will not.
Read the detailed description
In literature, Cupping therapy(CT) has been shown to be used mostly for pain control and the majority of RCT studies have shown that CT has potential benefits in pain conditions. Previous studies have reported the effect of pain mediator substance-P, endorphins, encephalins and dynorphins on pain(1) In addition to pain control, it is recommended for use as additional treatment in neurological diseases such as paralysis, Parkinson's disease and stroke Studies have shown successful results in the short term with the application of CT for migraine and tension-type headaches (2,3) Methodology Study design and Patient selection Patients with a history of migraine diagnosis who presented at the Research Polyclinic of Karabuk University Training and Research Hospital for wet-cupping therapy in the period May 2016-January 2018 were included in the study. Patients were excluded if they had a history of head and neck surgery, a diagnosis of sinusitis, a diagnosis of fibromyalgia and inflammatory disease (rheumatism, infection etc.), were pregnant, had a diagnosis of cancer, bleeding disorder and widespread skin disease, malignant hypertension or any other disease which could cause headache. The diagnosis of migraine was confirmed by an experienced neurologist and the migraine type was determined. The medical treatments of the patients were reviewed and MIDAS was applied to determine the baseline score. In addition to the medical treatment, WCT was applied once a month, 3 times (Day 0, 30, 60). At the end of the 3rd month patients were allocated into two parallel arms. They were randomly assigned to the intervention group or control group in a double blind manner by the sealed opaque envelope technique. Intervention group continued WCT whereas patients in the control group discontinued the treatment. MIDAS was applied again at the end of the 6th and 12th months to both of the groups. Disability values in the 6th and 12th months were evaluated with MIDAS between those who continued treatment (Group 1) and those who did not (Group 2). Approval for the study was granted by Turgut Ozal University Ethics Committee, with number 99950669/236, dated 30.06.2014.Study design, application procedures and any possible side effects were explained to the study participants and informed consents obtained. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
MIDAS The migraine disability score is a scale evaluating disability and loss associated with migraine. It consists of 7 questions, the 1st, 3rd and 5th of which evaluate the days lost from school, work, housework or leisure activities because of headaches in the last 3 months. The 2nd and 4th questions evaluate the number of additional days lost from work or housework in the last 3 months due to a reduction in productivity (defined as at least a 50% reduction in productivity). An additional two questions (MIDAS A and B) evaluate the frequency of headaches and the severity of the headaches using a visual analog scale (VAS), but these are not added to the total MIDAS score. The total MIDAS points are obtained from the total of the first 5 questions. Total points of 0-5 = 1st degree (very little or no restriction), 6-10 points =2nd degree (mild or occasional restriction), 11-20 points = 3rd degree (moderate level of restriction), and 21 + points = 4th degree (severe restriction).
- Being tested
- Wet Cupping
- Keywords
- Wet cupping therapy, Migraine, MIDAS
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wet CuppingProcedure or surgery
cupping technique procedure was conducted in five phases:Primary suction,Area disinfection,Scarification,Bloodletting and secondary suction and Removing and dressing
| Study group | Role | What they receive |
|---|---|---|
| Continue WCT Application | Active comparator | From the 3rd month to the 12th month Wet cupping applied as an intervention MIDAS was applied at the end of the 6th and 12th months. Receives: Procedure: Wet Cupping |
| Discontinue WCT Application | No intervention | No intervention in this arm.Only MIDAS applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
MIDAS evaluation
Improvement in the Disability values which were evaluated with MIDAS
Measured: At the end of the 12th month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start3 Jan 2017
- Primary completion1 Feb 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies 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
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SULEYMAN ERSOY, Karabuk University
- Investigators
- SULEYMAN ERSOY, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479060
- Sponsor's protocol ID
- KBU-BAP-14/1-KA-057.
- Status last verified
- Jun 2018
- First submitted
- 14 Mar 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sajid MI. Hijama therapy (wet cupping) - its potential use to complement British healthcare in practice, understanding, evidence and regulation. Complement Ther Clin Pract. 2016 May;23:9-13. doi: 10.1016/j.ctcp.2016.01.003. Epub 2016 Feb 1.
PubMed 27157951Ahmadi A, Schwebel DC, Rezaei M. The efficacy of wet-cupping in the treatment of tension and migraine headache. Am J Chin Med. 2008;36(1):37-44. doi: 10.1142/S0192415X08005564.
PubMed 18306448Benli AR, Oruc MA. What is the difference of effectiveness of wet cupping therapy in migraine types?. Biomedical Research, 2017, 28.20.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continue or Stop Applying Wet Cupping (Al-Hijamah) in Migraine Headache: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03479060
- Acronym / sponsor ID
- KBU-BAP-14/1-KA-057.
- Keywords
- Wet cupping therapy, Migraine, MIDAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 27 Mar 2018 (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.
This study evaluates the short and long-term effects of application of Wet Cupping Therapy (WCT) in the treatment of migraine headaches in adults.Half of the participants will continue WCT application and the other half will not.
Detailed description
In literature, Cupping therapy(CT) has been shown to be used mostly for pain control and the majority of RCT studies have shown that CT has potential benefits in pain conditions. Previous studies have reported the effect of pain mediator substance-P, endorphins, encephalins and dynorphins on pain(1) In addition to pain control, it is recommended for use as additional treatment in neurological diseases such as paralysis, Parkinson's disease and stroke Studies have shown successful results in the short term with the application of CT for migraine and tension-type headaches (2,3) Methodology Study design and Patient selection Patients with a history of migraine diagnosis who presented at the Research Polyclinic of Karabuk University Training and Research Hospital for wet-cupping therapy in the period May 2016-January 2018 were included in the study. Patients were excluded if they had a history of head and neck surgery, a diagnosis of sinusitis, a diagnosis of fibromyalgia and inflammatory disease (rheumatism, infection etc.), were pregnant, had a diagnosis of cancer, bleeding disorder and widespread skin disease, malignant hypertension or any other disease which could cause headache. The diagnosis of migraine was confirmed by an experienced neurologist and the migraine type was determined. The medical treatments of the patients were reviewed and MIDAS was applied to determine the baseline score. In addition to the medical treatment, WCT was applied once a month, 3 times (Day 0, 30, 60). At the end of the 3rd month patients were allocated into two parallel arms. They were randomly assigned to the intervention group or control group in a double blind manner by the sealed opaque envelope technique. Intervention group continued WCT whereas patients in the control group discontinued the treatment. MIDAS was applied again at the end of the 6th and 12th months to both of the groups. Disability values in the 6th and 12th months were evaluated with MIDAS between those who continued treatment (Group 1) and those who did not (Group 2). Approval for the study was granted by Turgut Ozal University Ethics Committee, with number 99950669/236, dated 30.06.2014.Study design, application procedures and any possible side effects were explained to the study participants and informed consents obtained. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
MIDAS The migraine disability score is a scale evaluating disability and loss associated with migraine. It consists of 7 questions, the 1st, 3rd and 5th of which evaluate the days lost from school, work, housework or leisure activities because of headaches in the last 3 months. The 2nd and 4th questions evaluate the number of additional days lost from work or housework in the last 3 months due to a reduction in productivity (defined as at least a 50% reduction in productivity). An additional two questions (MIDAS A and B) evaluate the frequency of headaches and the severity of the headaches using a visual analog scale (VAS), but these are not added to the total MIDAS score. The total MIDAS points are obtained from the total of the first 5 questions. Total points of 0-5 = 1st degree (very little or no restriction), 6-10 points =2nd degree (mild or occasional restriction), 11-20 points = 3rd degree (moderate level of restriction), and 21 + points = 4th degree (severe restriction).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continue WCT Application | Active comparator | Procedure: Wet CuppingFrom the 3rd month to the 12th month Wet cupping applied as an intervention MIDAS was applied at the end of the 6th and 12th months. |
| Discontinue WCT Application | No intervention | –No intervention in this arm.Only MIDAS applied |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- History of head and neck surgery, Diagnosis of sinusitis Diagnosis of fibromyalgia and inflammatory disease (rheumatism, infection etc.) Diagnosis of cancer Diagnosis of bleeding disorder Malignant hypertension
- -
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 Cuppingcupping technique procedure was conducted in five phases:Primary suction,Area disinfection,Scarification,Bloodletting and secondary suction and Removing and dressing | Procedure or surgery | Continue WCT Application |
Primary outcome
MIDAS evaluation
Time frame: At the end of the 12th month.
Improvement in the Disability values which were evaluated with MIDAS
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 6 Jun 2018.
- Background: PubMed 27157951Sajid MI. Hijama therapy (wet cupping) - its potential use to complement British healthcare in practice, understanding, evidence and regulation. Complement Ther Clin Pract. 2016 May;23:9-13. doi: 10.1016/j.ctcp.2016.01.003. Epub 2016 Feb 1.
- Background: PubMed 18306448Ahmadi A, Schwebel DC, Rezaei M. The efficacy of wet-cupping in the treatment of tension and migraine headache. Am J Chin Med. 2008;36(1):37-44. doi: 10.1142/S0192415X08005564.
- BackgroundBenli AR, Oruc MA. What is the difference of effectiveness of wet cupping therapy in migraine types?. Biomedical Research, 2017, 28.20.
- Individual participant dataSharing planned: Undecided
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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.
SULEYMAN ERSOY principal investigator
Karabuk University
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 in people with Migraine Disorders and Migraine With Aura, 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 0 inclusion and 2 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 6 Jun 2018. 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?
MIDAS evaluation (time frame: At the end of the 12th month.). 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 NCT03479060, which also lists 3 linked publications.
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 6 Jun 2018.