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

NCT06568757 | Not Yet Recruiting DMC

• 1 other identifier: Wet Cupping Therapy
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Migraine-related Headache

Keywords

wet cupping; migraine; headache; disability

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Day 1

Secondary Outcomes (2)

• Wet Cupping Therapy Patient Opinion Form (Post-Intervention)

  1 months later

• Migraine Disability Assessment Scale (MIDAS)

  3 months later

Study Arms (2)

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

Other: Wet Cupping

Control Group

ACTIVE COMPARATOR

The group that will not receive any treatment other than medical treatment

Other: No intervention

Interventions

Wet Cupping OTHER

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).

Wet Cupping Group

No intervention OTHER

No treatment will be applied to individuals and the routine medical treatment program will continue.

Control Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Related Publications (1)

• 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.

  PMID: 33793142 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sultan Çeçen

CONTACT

+90 364 2231561; sultancecen@hitit.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer PhD

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: September 23, 2024
• Primary Completion: October 24, 2024
• Study Completion: March 17, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share