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

Primary Purpose

Migraine Disorders, Migraine With Aura, Migraine Without Aura

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Wet Cupping
Sponsored by
Karabuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring Wet cupping therapy, Migraine, MIDAS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Karabuk University Karabuk Research and Education hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Continue WCT Application

Discontinue WCT Application

Arm Description

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.

No intervention in this arm.Only MIDAS applied

Outcomes

Primary Outcome Measures

MIDAS evaluation
Improvement in the Disability values which were evaluated with MIDAS

Secondary Outcome Measures

Full Information

First Posted
March 14, 2018
Last Updated
June 4, 2018
Sponsor
Karabuk University
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1. Study Identification

Unique Protocol Identification Number
NCT03479060
Brief Title
Continue or Stop Applying Wet Cupping (Al-Hijamah) in Migraine
Official Title
Continue or Stop Applying Wet Cupping (Al-Hijamah) in Migraine Headache: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karabuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders, Migraine With Aura, Migraine Without Aura
Keywords
Wet cupping therapy, Migraine, MIDAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continue WCT Application
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Discontinue WCT Application
Arm Type
No Intervention
Arm Description
No intervention in this arm.Only MIDAS applied
Intervention Type
Procedure
Intervention Name(s)
Wet Cupping
Intervention Description
cupping technique procedure was conducted in five phases:Primary suction,Area disinfection,Scarification,Bloodletting and secondary suction and Removing and dressing
Primary Outcome Measure Information:
Title
MIDAS evaluation
Description
Improvement in the Disability values which were evaluated with MIDAS
Time Frame
At the end of the 12th month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SULEYMAN ERSOY
Organizational Affiliation
Karabuk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karabuk University Karabuk Research and Education hospital
City
Karabük
State/Province
Karabuk
ZIP/Postal Code
78070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27157951
Citation
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.
Results Reference
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PubMed Identifier
18306448
Citation
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.
Results Reference
background
Citation
Benli AR, Oruc MA. What is the difference of effectiveness of wet cupping therapy in migraine types?. Biomedical Research, 2017, 28.20.
Results Reference
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Continue or Stop Applying Wet Cupping (Al-Hijamah) in Migraine

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