- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05202171
The Effects of Cervical Stabilization Exercise Training With Telerehabilitation in Individuals With Migraine
January 10, 2022 updated by: seyda toprak celenay, Ankara Yildirim Beyazıt University
The aim of our study is to investigate the effects of cervical stabilization exercise training applied with telerehabilitation in individuals with migraine.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Cervical muscles are adversely affected in individuals with migraine.
It is important to investigate the effects of cervical muscle training in these individuals.
Telerehabilitation applications have been used frequently in many patients in recent years.
It is necessary to examine the effects of cervical stabilization exercises applied with telerehabilitation in individuals with migraine.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
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
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being between the ages of 18-55,
- To be diagnosed with migraine by a neurologist according to International Headache Society criteria,
- Having at least 3 migraine attacks per month,
- Volunteering to participate in the study,
- Having the opportunity to access devices such as computers, phones and tablets with internet connection,
- Not having any problems that prevent cooperation and understanding
Exclusion Criteria:
- Having other accompanying headache types,
- Being pregnant,
- Being in the breastfeeding period,
- Having a history of trauma, fracture or surgery in the craniocervical region,
- Presence of concomitant neurological and/or inflammatory rheumatic disease
- Presence of serious psychiatric problems,
- History of malignancy,
- Changes in medical treatment during the study period,
- Receiving physiotherapy for the cervical region in the last 6 months
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: Exercise group
Exercise group will be performed cervical stabilization exercise training applied with telerehabilitation and standard treatment ( preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine) for 8 weeks
|
Exercise group will be performed cervical stabilization exercise training applied with telerehabilitation and standard treatment ( preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine) for 8 weeks
|
|
Active Comparator: Standard treatment group
Standard treatment group will be given preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine for 8 weeks.
|
standard treatment will include preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The characteristic of the migraine
Time Frame: change from baseline at 8 weeks
|
The characteristic of the migraine will be evaluated with the "Headache Diary".
|
change from baseline at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical range of motion
Time Frame: change from baseline at 8 weeks
|
Cervical range of motion was evaluated using the goniometer
|
change from baseline at 8 weeks
|
|
Upper cervical region movements
Time Frame: change from baseline at 8 weeks
|
Upper cervical region movements will be evaluated with a Cervical Range of Motion device
|
change from baseline at 8 weeks
|
|
Performance of the deep neck flexor muscles
Time Frame: change from baseline at 8 weeks
|
Performance of the deep neck flexor muscles will be evaluated with a Stabilizer Pressure Biofeedback Unit
|
change from baseline at 8 weeks
|
|
Cranio-vertebral angle
Time Frame: change from baseline at 8 weeks
|
The cranio-vertebral angle will be measured with a goniometer
|
change from baseline at 8 weeks
|
|
Disability Status
Time Frame: change from baseline at 8 weeks
|
The Turkish version of Migraine Disability Assessment Scale will be used to determine the disability status in daily activities of individuals due to migraine
|
change from baseline at 8 weeks
|
|
Sleep quality
Time Frame: change from baseline at 8 weeks
|
Sleep quality will be evaluated with the Turkish version of Jenkins Sleep Scale
|
change from baseline at 8 weeks
|
|
Life quality
Time Frame: change from baseline at 8 weeks
|
Life quality will be evaluated with the Turkish version of Headache Impact Test
|
change from baseline at 8 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 (Anticipated)
February 1, 2022
Primary Completion (Anticipated)
February 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
January 10, 2022
First Submitted That Met QC Criteria
January 10, 2022
First Posted (Actual)
January 21, 2022
Study Record Updates
Last Update Posted (Actual)
January 21, 2022
Last Update Submitted That Met QC Criteria
January 10, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/01/8
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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
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-
Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
-
Fundación de Investigación Biomédica - Hospital...Hospital Universitario La Fe; Hospital Vall d'Hebron; Hospital Universitario... and other collaboratorsRecruitingMigraine | Migraine Disorders | Migraine Headache | Migraine Without Aura | Migraine With AuraSpain
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