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

January 27, 2021 updated by: Laura Smilgiene, Lithuanian University of Health Sciences

Changes and Associations Between Cervical Range of Motion, Pain, Temporomandibular Joint 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Kaunas, Lithuania
        • Lithuanian University of Health Sciences, Department of Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

37 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Intervention group (n=10) received 12 physiotherapy sessions and exercises for TMJ 30-45 minutes 2 days per week.
Other: Aerobic exercise and exercise for TMJ
Aerobic exercise
Active Comparator: Control group
Control group (n=9) was introduced with physiotherapy program in order to perform it independently at home.
Other: Aerobic exercise at home
Aerobic exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 6 weeks
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
Baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometry for TMJ
Time Frame: Baseline and after 6 weeks
TMJ range of motion was measured with a centimeter before and after physiotherapy
Baseline and after 6 weeks
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.
Baseline and after 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lithuanian University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2020

Primary Completion (Actual)

August 20, 2020

Study Completion (Actual)

August 24, 2020

Study Registration Dates

First Submitted

January 21, 2021

First Submitted That Met QC Criteria

January 27, 2021

First Posted (Actual)

January 28, 2021

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine

Clinical Trials on Aerobic exercise and exercise for TMJ

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe