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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05972382
Other study ID # CGH01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 28, 2023
Est. completion date January 15, 2024

Study information

Verified date July 2023
Source Ahram Canadian University
Contact Mohamed M ElMeligie, Ph.d
Phone +201064442032
Email mohamed.elmeligie@acu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 15, 2024
Est. primary completion date December 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Quantitative Sensory and Neurophysiological Testing
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.

Locations

Country Name City State
Egypt Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al ?ayy Ath Thamin Giza

Sponsors (1)

Lead Sponsor Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Secondary 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. Baseline
Secondary 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). baseline
Secondary 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. Baseline
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