The Effect of Connective Tissue Massage in Patients With Migraine
Primary Purpose
Migraine With Aura, Migraine, Migraine Without Aura
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Connective Tissue Massage
Education
Sponsored by
About this trial
This is an interventional treatment trial for Migraine With Aura
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Migraine Disease
- Being volunteer
Exclusion Criteria:
- Serious psychiatric problems with mental and / or communication problems Neurological, inflammatory or endocrine disease
Sites / Locations
- Özge Çoban
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Migraine group
Control group
Arm Description
The study included patients diagnosed by migraine according to International Headache Community criteria with18-65 years of age followed by routine controls and who were volunteered
The study included patients diagnosed by migraine according to International Headache Community criteria with 8-65 years of age followed by routine controls and were volunteered
Outcomes
Primary Outcome Measures
Migraine Disability Assessment Test
To assess the level of disability of patients Migraine Disability Assessment Test (MIDAS) was used. It is a widely used and validated test. MIDAS was translated into Turkish and validity and reliability studies were conducted. MIDAS is a test filled in by patients that identifies migraine disability in all areas of activity during last 3 months.It consists of 5 questions.The total MIDAS score is the sum of the days given as response to these five questions (MIDAS 1 to MIDAS 5). The total score ranges from 0 to 90 and is used to categorize patients in disability grades I to IV. A higher score means more severe disability, placing the patient in a higher disability grade
Secondary Outcome Measures
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index to evaluate sleep quality (PSQI) will be used. It is a reliable and valid scale with 19 questions to assess the presence and severity of the disorder. The questionnaire was adapted to Turkish patients by Ağargün et al. The scale can measure subjective sleep quality, sleep latency, sleep time, sleep efficiency, sleep disturbance, sleep medication use and daytime work. The response of each is scored as 0-3. Having a global score of 5 or higher, indicates bad sleep quality.
Hospital Anxiety and Depression Scale (
Hospital Anxiety and Depression Scale (HADS) will be usedl to assess the anxiety and depression. Validity and reliability of HADS in Turkish was established by Aydemir et al. This scale consists of 14 questions. Half of questions (odd numbers) measures anxiety and the other half (even numbers) measures depression. Answers quartet likert format and are scored between 0-3. The lowest score they can get from the sub-scale is 0, the highest score is 21 for each subscale. 10 point is considered as a treshold for depression and or anxiety.
Nothingham Health Profile
Nothingham Health Profile was used to measure quality of life. Nottingham Health Profile, emotional, physical and social problems survey. The Turkish validity was made in 1997 by Küçükdeveci et al.There are 6 sub-sections in the survey which consists of 38 questions in total. These sections include pain (8 questions), physical activity (8 questions),fatigue (3 questions), sleep (5 questions), social isolation (5 questions) and emotional reactions (9 questions) the participant is asked to answer these questions in the form of yes or no. Total score for each section scored as 0-100."0 points" indicates the best health status, "100 points indicates the worst health status.
Allodynia Symptom Checklist
To evaluate allodynia symptoms associated with headache attacks "Allodynia Symptom Checklist" will be used. 12 different situations are questioned in this list. Each situations are scored as "does not apply to me", "never", "rarely", "less than half", "half or more often". ITotal score ranged between 0-24 points.
Full Information
NCT ID
NCT04171362
First Posted
November 18, 2019
Last Updated
September 4, 2020
Sponsor
Ankara Yildirim Beyazıt University
1. Study Identification
Unique Protocol Identification Number
NCT04171362
Brief Title
The Effect of Connective Tissue Massage in Patients With Migraine
Official Title
The Effect of Connective Tissue Massage in Patients With Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara Yildirim Beyazıt 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 aim of this study was to investigate the effectiveness of connective tissue massage in patients with migraine
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura, Migraine, Migraine Without Aura, Connective Tissue Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Migraine group
Arm Type
Experimental
Arm Description
The study included patients diagnosed by migraine according to International Headache Community criteria with18-65 years of age followed by routine controls and who were volunteered
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The study included patients diagnosed by migraine according to International Headache Community criteria with 8-65 years of age followed by routine controls and were volunteered
Intervention Type
Other
Intervention Name(s)
Connective Tissue Massage
Intervention Description
Connective tissue massage (CTM) is a manipulative technique that facilitates the diagnosis and treatment of a wide range of pathologies. Observation and subsequent manipulation of the skin and subcutaneous tissues can have a beneficial effect upon tissues remote from the area of treatment.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Education patients were informed about migraine triggers, migraine prevention and coping strategies and exercise options. The exercises were demonstrated by the physiotherapist
Primary Outcome Measure Information:
Title
Migraine Disability Assessment Test
Description
To assess the level of disability of patients Migraine Disability Assessment Test (MIDAS) was used. It is a widely used and validated test. MIDAS was translated into Turkish and validity and reliability studies were conducted. MIDAS is a test filled in by patients that identifies migraine disability in all areas of activity during last 3 months.It consists of 5 questions.The total MIDAS score is the sum of the days given as response to these five questions (MIDAS 1 to MIDAS 5). The total score ranges from 0 to 90 and is used to categorize patients in disability grades I to IV. A higher score means more severe disability, placing the patient in a higher disability grade
Time Frame
change from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
Pittsburgh Sleep Quality Index to evaluate sleep quality (PSQI) will be used. It is a reliable and valid scale with 19 questions to assess the presence and severity of the disorder. The questionnaire was adapted to Turkish patients by Ağargün et al. The scale can measure subjective sleep quality, sleep latency, sleep time, sleep efficiency, sleep disturbance, sleep medication use and daytime work. The response of each is scored as 0-3. Having a global score of 5 or higher, indicates bad sleep quality.
Time Frame
change from baseline at 4 weeks
Title
Hospital Anxiety and Depression Scale (
Description
Hospital Anxiety and Depression Scale (HADS) will be usedl to assess the anxiety and depression. Validity and reliability of HADS in Turkish was established by Aydemir et al. This scale consists of 14 questions. Half of questions (odd numbers) measures anxiety and the other half (even numbers) measures depression. Answers quartet likert format and are scored between 0-3. The lowest score they can get from the sub-scale is 0, the highest score is 21 for each subscale. 10 point is considered as a treshold for depression and or anxiety.
Time Frame
change from baseline at 4 weeks
Title
Nothingham Health Profile
Description
Nothingham Health Profile was used to measure quality of life. Nottingham Health Profile, emotional, physical and social problems survey. The Turkish validity was made in 1997 by Küçükdeveci et al.There are 6 sub-sections in the survey which consists of 38 questions in total. These sections include pain (8 questions), physical activity (8 questions),fatigue (3 questions), sleep (5 questions), social isolation (5 questions) and emotional reactions (9 questions) the participant is asked to answer these questions in the form of yes or no. Total score for each section scored as 0-100."0 points" indicates the best health status, "100 points indicates the worst health status.
Time Frame
Before the treatment and end of 4 weeks
Title
Allodynia Symptom Checklist
Description
To evaluate allodynia symptoms associated with headache attacks "Allodynia Symptom Checklist" will be used. 12 different situations are questioned in this list. Each situations are scored as "does not apply to me", "never", "rarely", "less than half", "half or more often". ITotal score ranged between 0-24 points.
Time Frame
change from baseline at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Migraine Disease
Being volunteer
Exclusion Criteria:
Serious psychiatric problems with mental and / or communication problems Neurological, inflammatory or endocrine disease
Facility Information:
Facility Name
Özge Çoban
City
Ankara
ZIP/Postal Code
06760
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Connective Tissue Massage in Patients With Migraine
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