The Effect of Connective Tissue Massage in Patients With Migraine

Sponsor
Ankara Yildirim Beyazıt University (Other)
Overall Status
Completed
CT.gov ID
NCT04171362
Collaborator
(none)
16
1
2
8.8
1.8

Study Details

Study Description

Brief Summary

The aim of this study was to investigate the effectiveness of connective tissue massage in patients with migraine

Condition or Disease Intervention/Treatment Phase
  • Other: Connective Tissue Massage
  • Other: Education
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Connective Tissue Massage in Patients With Migraine
Actual Study Start Date :
Mar 28, 2019
Actual Primary Completion Date :
Dec 10, 2019
Actual Study Completion Date :
Dec 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Migraine group

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

Other: Connective Tissue Massage
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.

Other: Education
Education patients were informed about migraine triggers, migraine prevention and coping strategies and exercise options. The exercises were demonstrated by the physiotherapist

Active Comparator: Control group

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

Other: Education
Education patients were informed about migraine triggers, migraine prevention and coping strategies and exercise options. The exercises were demonstrated by the physiotherapist

Outcome Measures

Primary Outcome Measures

  1. Migraine Disability Assessment Test [change from baseline at 4 weeks]

    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

  1. Pittsburgh Sleep Quality Index [change from baseline at 4 weeks]

    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.

  2. Hospital Anxiety and Depression Scale ( [change from baseline at 4 weeks]

    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.

  3. Nothingham Health Profile [Before the treatment and end of 4 weeks]

    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.

  4. Allodynia Symptom Checklist [change from baseline at 4 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Özge Çoban Ankara Turkey 06760

Sponsors and Collaborators

  • Ankara Yildirim Beyazıt University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ankara Yildirim Beyazıt University
ClinicalTrials.gov Identifier:
NCT04171362
Other Study ID Numbers:
  • 2019-22.
First Posted:
Nov 20, 2019
Last Update Posted:
Sep 7, 2020
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 7, 2020