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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04729699
Other study ID # 001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 13, 2020
Est. completion date August 24, 2020

Study information

Verified date January 2021
Source Lithuanian University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the effects of physiotherapy program and review the associations between neck movements, pain, temporomandibular joint (TMJ) movements and quality of life in individuals with migraine.


Description:

Migraine is one of the most common type of headaches in the world causing the greatest disability in individuals under 50 years of age. Many different health organizations (American Headache Society etc.) recommend regular physical activity and exercise for the treatment and prevention of migraine. However, the relationship between aerobic exercise and migraine is still not completely clear. Unfortunately, a research database to validate the benefits of exercise for people with migraine is still being developed. The aim of this study is to assess the effects of physiotherapy program and review the associations between neck movements, pain, temporomandibular movements and quality of life in individuals with migraine. The study was approved by Committee on Biomedical Research Ethics of Kaunas Region (2020-06-30 No.BEC-SR(M)-266).


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date August 24, 2020
Est. primary completion date August 20, 2020
Accepts healthy volunteers No
Gender Female
Age group 37 Years to 50 Years
Eligibility Inclusion Criteria: - Individuals diagnosed with migraine 2 or more years ago - Headache, occurring at least 6 times a year - Individuals from 18 years of age - Voluntary patient consent to participate in the study Exclusion Criteria: - Neurological or psychiatric disorder - Visiting an orthodontist, taking muscle relaxants - Head or neck injury, cervical spine hernia, facial or temporomandibular injury

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Aerobic exercise and exercise for TMJ
Aerobic exercise
Aerobic exercise at home
Aerobic exercise

Locations

Country Name City State
Lithuania Lithuanian University of Health Sciences, Department of Rehabilitation Kaunas

Sponsors (1)

Lead Sponsor Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Goniometry for cervical range of motion Cervical flexion (45°), extension (35°) and lateral flexion (45°) were measured with mechanical goniometer. Baseline to 6 weeks
Primary Algometry for pressure pain thresholds (PPT) PPT were measured in temporalis, upper trapezius and masticatory muscles with digital algometer in kg/cm² Baseline to 6 weeks
Secondary Anthropometry for TMJ TMJ range of motion was measured with a centimeter before and after physiotherapy Baseline and after 6 weeks
Secondary Functional health and well-being - SF-36v2® Quality of life was assessed with the SF-36 questionnaire. Measure is divided into 8 subscales: Physical Functioning, Activity Limitation due to Physical Ailments, General Health, Vitality, Social Functioning, Activity Limitation due to Emotional Problems, General Mental Health and Health Transition. Answers were scored (total score 100) and a higher total score meant a better quality of life. Baseline and after 6 weeks
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