Cervicogenic HeadacheNCT05972382
Associations Between Neck Muscle Fatigue, Joint Position Sense, and Headache in Cervicogenic Headache
An observational study of Cervicogenic Headache, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Quantitative Sensory and Neurophysiological Testing
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jul 2023to 15 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults with chronic cervicogenic headache recruited from neurology clinics
Who may be able to join
- Ages 18-60 years
- Chronic CGH (>3 months duration)
- Headache frequency ≥15 days/month
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervicogenic Headache
- Being tested
- Quantitative Sensory and Neurophysiological Testing
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory and Neurophysiological TestingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Cervicogenic Headache | Individuals with chronic cervicogenic headache (>3 months duration) Receives: Diagnostic Test: Quantitative Sensory and Neurophysiological Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Pain Intensity
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.
Measured: Baseline
Secondary outcomes (3)
Headache Disability
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.
Measured: Baseline
Neck Flexor Fatigue
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).
Measured: baseline
Cervical Joint Position Sense
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start28 Jul 2023 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies 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
- 30 participants (estimated)
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
- NCT05972382
- Sponsor's protocol ID
- CGH01
- Status last verified
- Jul 2023
- First submitted
- 24 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- 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 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Associations Between Neck Flexor Muscle Fatigue, Cervical Joint Position Sense Errors, and Headache Pain and Disability in Individuals With Chronic Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT05972382
- Acronym / sponsor ID
- CGH01
- Conditions
- Cervicogenic Headache
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 28 Jul 2023 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 2 Aug 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 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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervicogenic Headache | – | Diagnostic Test: Quantitative Sensory and Neurophysiological TestingIndividuals with chronic cervicogenic headache (>3 months duration) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults with chronic cervicogenic headache recruited from neurology clinics
Key inclusion criteria (3 listed)
- Ages 18-60 years
- Chronic CGH (>3 months duration)
- Headache frequency ≥15 days/month
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Quantitative Sensory and Neurophysiological TestingParticipants 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. | Diagnostic test | Cervicogenic Headache |
Primary outcome
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.
3 secondary outcomes
Headache Disability
Time frame: Baseline
Neck Flexor Fatigue
Time frame: baseline
Cervical Joint Position Sense
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- 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 Cervicogenic Headache, 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: status not confirmed, as of the sponsor's last update on 2 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Pain Intensity (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 2 Aug 2023.