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OpenTrials
Completed

NCT Number: NCT04729699

Changes and Associations Between Cervical Range of Motion, Pain, TMJ Range of Motion and Quality of Life in Migraineurs Applying Physical Therapy

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Aerobic exercise and exercise for TMJ

Other

Aerobic exercise

Aerobic exercise at home

Other

Aerobic exercise

Primary outcomes

  1. Goniometry for cervical range of motion

    Time frame: Baseline to 6 weeks

    Cervical flexion (45⁰), extension (35⁰) and lateral flexion (45⁰) were measured with mechanical goniometer.

  2. Algometry for pressure pain thresholds (PPT)

    Time frame: Baseline to 6 weeks

    PPT were measured in temporalis, upper trapezius and masticatory muscles with digital algometer in kg/cm²

Secondary outcomes

  1. Anthropometry for TMJ

    Time frame: Baseline and after 6 weeks

    TMJ range of motion was measured with a centimeter before and after physiotherapy

  2. Functional health and well-being - SF-36v2®

    Time frame: Baseline and after 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

Changes and Associations Between Cervical Range of Motion, Pain, Temporomandibular Joint Range of Motion and Quality of Life in Migraineurs Applying Physical Therapy

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2021
Registry last updated
Jan 28, 2021

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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