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
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
-
-
-
Kaunas, Lithuania
- Lithuanian University of Health Sciences, Department of Rehabilitation
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-
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.
|
Aerobic exercise
|
|
Active Comparator: Control group
Control group (n=9) was introduced with physiotherapy program in order to perform it independently 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.
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 (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES))
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.