Back to resultsThe Effect of Two Different Massages on Migraine
Primary Purpose
Headache, Migraine, Manuel Therapy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Connective tissue massage
Classical massage
Sponsored by
About this trial
This is an interventional treatment trial for Headache, Migraine
Eligibility Criteria
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
Sites / Locations
- Biruni University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
Connective tissue massage
Classical massage
Outcomes
Primary Outcome Measures
Pain Intensity
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.
Secondary Outcome Measures
Migraine Related Disability
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.
The Quality of Life
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.
Perceived Patient-Reported Change
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".
The general descriptive demographic information
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05452330
Brief Title
The Effect of Two Different Massages on Migraine
Official Title
Comparison of the Effectiveness of Connective Tissue Massage and Classical Massage in Patients With Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
September 9, 2022 (Actual)
Study Completion Date
September 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine, Manuel Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Connective tissue massage
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Classical massage
Intervention Type
Other
Intervention Name(s)
Connective tissue massage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Classical massage
Intervention Description
Classical massage will be applied with the techniques of stroking, kneading, and friction for 2 days a week, a total of 8 weeks.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Migraine Related Disability
Description
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.
Time Frame
8 weeks
Title
The Quality of Life
Description
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.
Time Frame
8 weeks
Title
Perceived Patient-Reported Change
Description
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".
Time Frame
8th week (one week)
Title
The general descriptive demographic information
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arzu Özdinçler, PhD
Organizational Affiliation
Biruni University
Official's Role
Study Chair
Facility Information:
Facility Name
Biruni University
City
Istanbul
State/Province
Zeytinburnu
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Two Different Massages on Migraine
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