- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05972382
Associations Between Neck Muscle Fatigue, Joint Position Sense, and Headache in Cervicogenic Headache
Investigating Associations Between Neck Flexor Muscle Fatigue, Cervical Joint Position Sense Errors, and Headache Pain and Disability in Individuals With Chronic Cervicogenic Headache
This research study aims to better understand the relationships between neck muscle function, neck joint position sense, and headache pain and disability in people with chronic cervicogenic headache. Cervicogenic headache is headache originating from the neck area.
Participants will fill out questionnaires about their headache pain and ability to do daily activities. They will also do tests to measure neck muscle fatigue and neck joint position sense. Researchers will analyze if those with more neck muscle fatigue and poorer joint position sense have worse headache pain and disability.
The results may improve understanding of cervical spine factors related to cervicogenic headache. This could help guide more targeted treatment approaches.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic cervicogenic headache (CGH) is characterized by chronic headache originating from the upper cervical spine and occipital region. CGH is associated with impairments in cervical muscular control and proprioception or joint position sense. However, relationships between these cervical impairments and headache symptoms are not fully elucidated.
This cross-sectional quantitative study aims to investigate associations between neck flexor muscle fatigue, cervical joint position sense, and clinical headache parameters like pain and disability in individuals with CGH.
A sample of 30 adults ages 18-65 years old with CGH longer than 3 months duration and more than 15 headache days per month will be recruited from neurology clinics. Participants will attend a single 2 hour study visit.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mohamed M ElMeligie, Ph.d
- Phone Number: +201064442032
- Email: mohamed.elmeligie@acu.edu.eg
Study Locations
-
-
Giza
-
Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
- Recruiting
- Outpatient clinic of faculty of physical therapy, Ahram Canadian University
-
Contact:
- Mohamed M ElMeligie, Ph.d
- Phone Number: 01064442032
- Email: mohamed.elmeligie@acu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Ages 18-60 years
- Chronic CGH (>3 months duration)
- Headache frequency ≥15 days/month
Exclusion Criteria:
- Cervical nerve root compression or other specific pathologies explaining headache
- History of cervical spine surgery
- Botulinum toxin injections in cervical musculature in past 6 months
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cervicogenic Headache
Individuals with chronic cervicogenic headache (>3 months duration)
|
Participants will undergo the following quantitative sensory and neurophysiological diagnostic tests: Surface electromyography (EMG) of the neck flexor muscles during the craniocervical flexion test to assess neck flexor muscle fatigue. EMG sensors will be placed over the sternocleidomastoid and longus colli muscles. Cervical joint position error testing to evaluate proprioceptive awareness and cervicocephalic kinesthetic sensibility. Participants will be seated upright and blindfolded. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Headache Pain Intensity
Time Frame: Baseline
|
Average headache pain over the past week rated on a 0-10 Numerical Rating Scale (NRS).
Participants asked to rate their average pain level over the past week on a 0 to 10 scale, where 0 is no pain and 10 is the worst possible pain.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Headache Disability
Time Frame: Baseline
|
Total score on the 25-item Headache Disability Inventory (HDI) questionnaire, assessing headache-related disability over the past month.
Each item scored as yes (4 points), sometimes (2 points), or no (0 points).
Total score ranges from 0 to 100, with higher scores indicating greater disability.
|
Baseline
|
|
Neck Flexor Fatigue
Time Frame: baseline
|
Change in mean surface electromyography (EMG) amplitude (measured in microvolts) of the sternocleidomastoid and longus colli muscles from start to end of a 30-second craniocervical flexion contraction at 50% maximum voluntary contraction (MVC).
|
baseline
|
|
Cervical Joint Position Sense
Time Frame: Baseline
|
Absolute error in degrees between perceived and actual head repositioning after returning from 20 degrees of active right cervical rotation.
Average error over 3 trials used.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGH01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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