- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05452330
The Effect of Two Different Massages on Migraine
September 19, 2022 updated by: Begum Kara Kaya, Biruni University
Comparison of the Effectiveness of Connective Tissue Massage and Classical Massage in Patients With Migraine
The study aims to compare the effects of connective tissue massage on pain severity, attack frequency and duration, migraine-related disability, and quality of life in patients diagnosed with migraine, by comparing them with the classical massage.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
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 Locations
-
-
Zeytinburnu
-
Istanbul, Zeytinburnu, Turkey
- Biruni University
-
-
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
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Volunteers with a migraine diagnosis
- Taking only analgesics for migraine treatment and continuing their routines
- No problem in reading, writing and understanding Turkish
Exclusion Criteria:
- Having any other neurological problems
- Who had been injected with botulinum toxin in the last 3 months
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Connective tissue massage
|
Connective tissue massage will be applied with short and long pulling strokes to create a reflex effect for 2 days a week, a total of 8 weeks.
|
|
Experimental: Group 2
Classical massage
|
Classical massage will be applied with the techniques of stroking, kneading, and friction for 2 days a week, a total of 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 8 weeks
|
The intensity of pain perceived by the subjects will be evaluated with a valid method, the Visual Analogue Scale (VAS).
The higher numbers show higher pain intensities.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Migraine Related Disability
Time Frame: 8 weeks
|
The Migraine Disability Assessment Scale (MIDAS), which is considered valid and reliable, will be used to evaluate the migraine-related disability.
The higher scores indicate an increase in the severity of the disability.
|
8 weeks
|
|
The Quality of Life
Time Frame: 8 weeks
|
The patients' quality of life will be evaluated with the 24-hours Quality of Life in Migraine Scale (24-Hr-MQoLQ), which is valid and reliable.
The increase in the score obtained from the scale indicates an increase in the quality of life.
|
8 weeks
|
|
Perceived Patient-Reported Change
Time Frame: 8th week (one week)
|
The change perceived by the patients after the intervention will be evaluated with the Global Rating of Change Scale (GROC).
According to the scale, it is expressed as "-2: I am much worse, -1: I am worse, 0: No change, 1: I am better, 2: I am much better".
|
8th week (one week)
|
|
The general descriptive demographic information
Time Frame: 8 weeks
|
The general descriptive demographic information of the participants such as age and gender; migraine family history, duration of the complaints, attack frequency and duration will be questioned with a form prepared by the researchers.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Arzu Özdinçler, PhD, Biruni University
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 (Actual)
July 18, 2022
Primary Completion (Actual)
September 9, 2022
Study Completion (Actual)
September 16, 2022
Study Registration Dates
First Submitted
July 6, 2022
First Submitted That Met QC Criteria
July 6, 2022
First Posted (Actual)
July 11, 2022
Study Record Updates
Last Update Posted (Actual)
September 21, 2022
Last Update Submitted That Met QC Criteria
September 19, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Migren
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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