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Completed

NCT Number: NCT04171362

The Effect of Connective Tissue Massage in Patients With Migraine

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Özge Çoban

Ankara, 06760, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Connective Tissue Massage

Other

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.

Education

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2019
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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