MigraineNCT05933590
Cervical Repositioning Error in Chronic Migraine
An observational study of Migraine and Chronic Migraine, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
This study examines cervical joint position sense in individuals with chronic migraine vs. healthy controls. The ability to reposition the cervical spine after active movement will be evaluated in different head positions. Impaired proprioception and motor control is hypothesized in the migraine group. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine, Chronic Migraine
- What is being tested?
- Cervical Joint Repositioning Error Assessment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 6 Jan 2024
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes individuals aged 18-65 years old, with and without chronic migraine.
Who may be able to join
- Individuals aged 18-65 years old
- Diagnosis of chronic migraine (for the chronic migraine group)
- No history of migraine (for the control group)
Who cannot join
- History of cervical spine pathology
- Neurological deficits unrelated to migraine
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
About this study
Official title: Cervical Joint Repositioning Error in Different Head Positions Among Individuals With Chronic Migraine: A Cross-Sectional Study
This study examines cervical joint position sense in individuals with chronic migraine vs. healthy controls. The ability to reposition the cervical spine after active movement will be evaluated in different head positions. Impaired proprioception and motor control is hypothesized in the migraine group.
- Conditions
- Migraine, Chronic Migraine
- Being tested
- Cervical Joint Repositioning Error Assessment
- 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 Joint Repositioning Error AssessmentDiagnostic test
The cervical joint repositioning error assessment is a non-invasive diagnostic test used to measure the ability of an individual to accurately reproduce a specific head position in different orientations (flexion, neutral position, 50% range of motion of left rotation, and 50% range of motion of right rotation). Participants in both the chronic migraine group and the control group will undergo this assessment using a digital inclinometer. The primary outcome of this study is the difference between the initial and repositioned cervical joint angles, measured in degrees.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Migraine Group | This group consists of 25 individuals diagnosed with chronic migraine. They will undergo cervical joint repositioning error assessment in different head positions. Receives: Diagnostic Test: Cervical Joint Repositioning Error Assessment | |
| Control Group | This group consists of 25 age-matched healthy controls without a history of migraine. They will undergo the same cervical joint repositioning error assessment in different head positions. Receives: Diagnostic Test: Cervical Joint Repositioning Error Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Joint Repositioning Error Assessment
The cervical joint repositioning error assessment is a non-invasive diagnostic test used to measure the ability of an individual to accurately reproduce a specific head position in different orientations (flexion, neutral position, 50% range of motion of left rotation, and 50% range of motion of right rotation). Participants in both the chronic migraine group and the control group will undergo this assessment using a digital inclinometer.The primary outcome of this study is the difference between the initial and repositioned cervical joint angles, measured in degrees.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Jul 2023
- Primary completion6 Jan 2024
- Study completion6 Jan 2024
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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study chair, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933590
- Sponsor's protocol ID
- 012/2820236
- Status last verified
- Jan 2024
- First submitted
- 28 Jun 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Joint Repositioning Error in Different Head Positions Among Individuals With Chronic Migraine: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05933590
- Acronym / sponsor ID
- 012/2820236
- Conditions
- Migraine, Chronic Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 6 Jan 2024 (actual)
- Study completion
- 6 Jan 2024 (actual)
- First posted
- 6 Jul 2023 (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.
This study examines cervical joint position sense in individuals with chronic migraine vs. healthy controls. The ability to reposition the cervical spine after active movement will be evaluated in different head positions. Impaired proprioception and motor control is hypothesized in the migraine group.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Migraine Group | – | Diagnostic Test: Cervical Joint Repositioning Error AssessmentThis group consists of 25 individuals diagnosed with chronic migraine. They will undergo cervical joint repositioning error assessment in different head positions. |
| Control Group | – | Diagnostic Test: Cervical Joint Repositioning Error AssessmentThis group consists of 25 age-matched healthy controls without a history of migraine. They will undergo the same cervical joint repositioning error assessment in different head positions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes individuals aged 18-65 years old, with and without chronic migraine.
Key inclusion criteria (3 listed)
- Individuals aged 18-65 years old
- Diagnosis of chronic migraine (for the chronic migraine group)
- No history of migraine (for the control group)
Key exclusion criteria (3 listed)
- History of cervical spine pathology
- Neurological deficits unrelated to migraine
- Current pregnancy
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 Joint Repositioning Error AssessmentThe cervical joint repositioning error assessment is a non-invasive diagnostic test used to measure the ability of an individual to accurately reproduce a specific head position in different orientations (flexion, neutral position, 50% range of motion of left rotation, and 50% range of motion of right rotation). Participants in both the chronic migraine group and the control group will undergo this assessment using a digital inclinometer. The primary outcome of this study is the difference between the initial and repositioned cervical joint angles, measured in degrees. | Diagnostic test | Chronic Migraine Group, Control Group |
Primary outcome
Cervical Joint Repositioning Error Assessment
Time frame: Baseline
The cervical joint repositioning error assessment is a non-invasive diagnostic test used to measure the ability of an individual to accurately reproduce a specific head position in different orientations (flexion, neutral position, 50% range of motion of left rotation, and 50% range of motion of right rotation). Participants in both the chronic migraine group and the control group will undergo this assessment using a digital inclinometer.The primary outcome of this study is the difference between the initial and repositioned cervical joint angles, measured in degrees.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Amal Fawzy, Ph.d study chair
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Chronic Migraine, run by Ahram Canadian University at 1 site in Egypt.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Joint Repositioning Error Assessment (time frame: Baseline). 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 22 Jan 2024.