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Trial record 30 of 1138 for:    migraine

The Effect of Connective Tissue Massage in Patients With Migraine

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ClinicalTrials.gov Identifier: NCT04171362
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ankara Yildirim Beyazıt University

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
Migraine With Aura Migraine Migraine Without Aura Connective Tissue Diseases Other: Connective Tissue Massage Other: Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 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 : March 28, 2019
Estimated Primary Completion Date : December 10, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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




Primary Outcome Measures :
  1. Migraine Disability Assessment Test [ Time Frame: 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 [ Time Frame: 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 ( [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171362


Contacts
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Contact: Özge Çoban 05301362961 ozgecoban61@hotmail.com

Locations
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Turkey
Özge Çoban Recruiting
Ankara, Turkey, 06760
Contact: Özge Çoban    05301362961    ozgecoban61@hotmail.com   
Sponsors and Collaborators
Ankara Yildirim Beyazıt University

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Responsible Party: Ankara Yildirim Beyazıt University
ClinicalTrials.gov Identifier: NCT04171362     History of Changes
Other Study ID Numbers: 2019-22.
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Migraine with Aura
Migraine without Aura
Connective Tissue Diseases
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases