Continue or Stop Applying Wet Cupping (Al-Hijamah) in Migraine

• ClinicalTrials.gov Identifier: NCT03479060
• Recruitment Status: Completed
• First Posted: March 27, 2018
• Last Update Posted: June 6, 2018
• Sponsor: Karabuk University
• Information provided by (Responsible Party): SULEYMAN ERSOY, Karabuk University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Migraine Disorders; Migraine With Aura; Migraine Without Aura	Procedure: Wet Cupping	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 109 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Continue or Stop Applying Wet Cupping (Al-Hijamah) in Migraine Headache: A Randomized Control Trial
• Actual Study Start Date: January 3, 2017
• Actual Primary Completion Date: February 1, 2018
• Actual Study Completion Date: March 1, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Continue WCT Application; 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.	Procedure: Wet Cupping; cupping technique procedure was conducted in five phases:Primary suction,Area disinfection,Scarification,Bloodletting and secondary suction and Removing and dressing
No Intervention: Discontinue WCT Application; No intervention in this arm.Only MIDAS applied

Outcome Measures

Primary Outcome Measures :

1. MIDAS evaluation [ Time Frame: At the end of the 12th month. ]
   Improvement in the Disability values which were evaluated with MIDAS

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Creteria:Inclusion Criteria:

Subject has migraine headache

Exclusion Criteria:

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

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Contacts and Locations

Locations

Turkey

Karabuk University Karabuk Research and Education hospital

Karabük, Karabuk, Turkey, 78070

Sponsors and Collaborators

Karabuk University

Investigators

• Principal Investigator: SULEYMAN ERSOY; Karabuk University

  Study Documents (Full-Text)

Documents provided by SULEYMAN ERSOY, Karabuk University:

Statistical Analysis Plan  [PDF] December 3, 2017

Study Protocol  [PDF] March 5, 2017

More Information

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.

Ahmadi 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.

Benli AR, Oruc MA. What is the difference of effectiveness of wet cupping therapy in migraine types?. Biomedical Research, 2017, 28.20.

• Responsible Party: SULEYMAN ERSOY, Assist.Prof. Department of Family Medicine, Karabuk University
• ClinicalTrials.gov Identifier: NCT03479060
• Other Study ID Numbers: KBU-BAP-14/1-KA-057.
• First Posted: March 27, 2018
• Last Update Posted: June 6, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by SULEYMAN ERSOY, Karabuk University:

Wet cupping therapy; Migraine; MIDAS

Additional relevant MeSH terms:

Migraine Disorders; Migraine without Aura; Migraine with Aura; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases