Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568757
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
The Effect of Wet Cupping Therapy on Headache and Migraine-related Disability
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Wet Cupping Therapy on Headache Severity and Disability in Patients Diagnosed With Migraine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 220 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
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 220 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None