MigraineNCT05202171
The Effects of Cervical Stabilization Exercise Training With Telerehabilitation in Individuals With Migraine
A study testing Cervical Stabilization Exercise and Standard treatment in people with Migraine, run by Ankara Yildirim Beyazıt University.
Trial summary
The aim of our study is to investigate the effects of cervical stabilization exercise training applied with telerehabilitation in individuals with migraine. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Migraine
- What is being tested?
- Cervical Stabilization Exercise and Standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
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- History of malignancy,
- Changes in medical treatment during the study period,
- Receiving physiotherapy for the cervical region in the last 6 months
Trial locations and contacts
No sites are listed yet.
About this study
The aim of our study is to investigate the effects of cervical stabilization exercise training applied with telerehabilitation in individuals with migraine.
Read the 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.
- Conditions
- Migraine
- Being tested
- Cervical Stabilization Exercise, Standard treatment
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Stabilization ExerciseOther
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
Standard treatmentOther
standard treatment will include preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 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 Receives: Other: Cervical Stabilization Exercise |
| Standard treatment group | Active comparator | 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. Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The characteristic of the migraine
The characteristic of the migraine will be evaluated with the "Headache Diary".
Measured: change from baseline at 8 weeks
Secondary outcomes (7)
Cervical range of motion
Cervical range of motion was evaluated using the goniometer
Measured: change from baseline at 8 weeks
Upper cervical region movements
Upper cervical region movements will be evaluated with a Cervical Range of Motion device
Measured: change from baseline at 8 weeks
Performance of the deep neck flexor muscles
Performance of the deep neck flexor muscles will be evaluated with a Stabilizer Pressure Biofeedback Unit
Measured: change from baseline at 8 weeks
Cranio-vertebral angle
The cranio-vertebral angle will be measured with a goniometer
Measured: change from baseline at 8 weeks
Disability Status
The Turkish version of Migraine Disability Assessment Scale will be used to determine the disability status in daily activities of individuals due to migraine
Measured: change from baseline at 8 weeks
Sleep quality
Sleep quality will be evaluated with the Turkish version of Jenkins Sleep Scale
Measured: change from baseline at 8 weeks
Life quality
Life quality will be evaluated with the Turkish version of Headache Impact Test
Measured: change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study startFeb 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyda toprak celenay, Ankara Yildirim Beyazıt University
- Investigators
- Seyda Toprak Celenay, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202171
- Sponsor's protocol ID
- 2022/01/8
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 21 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cervical Stabilization Exercise Training With Telerehabilitation in Individuals With Migraine
- ClinicalTrials.gov ID
- NCT05202171
- Acronym / sponsor ID
- 2022/01/8
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of our study is to investigate the effects of cervical stabilization exercise training applied with telerehabilitation in individuals with migraine.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Cervical Stabilization ExerciseExercise 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 |
| Standard treatment group | Active comparator | Other: Standard treatmentStandard treatment group will be given preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine for 8 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical Stabilization ExerciseExercise 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 | Other | Exercise group |
| Standard treatmentstandard treatment will include preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine for 8 weeks | Other | Standard treatment group |
Primary outcome
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".
7 secondary outcomes
Cervical range of motion
Time frame: change from baseline at 8 weeks
Upper cervical region movements
Time frame: change from baseline at 8 weeks
Performance of the deep neck flexor muscles
Time frame: change from baseline at 8 weeks
Cranio-vertebral angle
Time frame: change from baseline at 8 weeks
Disability Status
Time frame: change from baseline at 8 weeks
Sleep quality
Time frame: change from baseline at 8 weeks
Life quality
Time frame: change from baseline at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyda Toprak Celenay principal investigator
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Stabilization Exercise and Standard treatment in people with Migraine, run by Ankara Yildirim Beyazıt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda Toprak Celenay (+90312 906 1000, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The characteristic of the migraine (time frame: change from baseline at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.