The Effect of Wet Cupping Therapy on Headache and Migraine-related Disability

August 21, 2024 updated by: Sultan ÇEÇEN, Mersin University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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,
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wet Cupping Group
The group that will receive wet cupping therapy-cupping application to the head and neck area in addition to medical treatment
Other: Wet Cupping
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).
Active Comparator: Control Group
The group that will not receive any treatment other than medical treatment
Other: No intervention
No treatment will be applied to individuals and the routine medical treatment program will continue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1
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).
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wet Cupping Therapy Patient Opinion Form (Post-Intervention)
Time Frame: 1 months later
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?"
1 months later
Migraine Disability Assessment Scale (MIDAS)
Time Frame: 3 months later
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).
3 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 23, 2024

Primary Completion (Estimated)

October 24, 2024

Study Completion (Estimated)

March 17, 2025

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wet Cupping Therapy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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