The Effect of Wet Cupping Therapy on Headache and Migraine-related Disability
NCT Number: NCT06568757
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Migraine-related Headache
Interventions: OTHER: Wet Cupping|OTHER: No intervention
Sponsor: Mersin University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-23
Completion Date: 2025-03-17

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.

Primary Outcome Measures: 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 Outcome Measures: Wet Cupping Therapy Patient Opinion Form (Post-Intervention), 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), 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