NCT05972382

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

July 28, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

July 24, 2023

Last Update Submit

July 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Headache Disability

    Baseline

  • Neck Flexor Fatigue

    baseline

  • Cervical Joint Position Sense

    Baseline

Study Arms (1)

Cervicogenic Headache

Individuals with chronic cervicogenic headache (\>3 months duration)

Diagnostic Test: Quantitative Sensory and Neurophysiological Testing

Interventions

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.

Cervicogenic Headache

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults with chronic cervicogenic headache recruited from neurology clinics

You may qualify if:

  • Ages 18-60 years
  • Chronic CGH (\>3 months duration)
  • Headache frequency ≥15 days/month

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Amal Fawzy, Ph.d

    Faculty of Physical Therapy, Ahram Canadian University

    STUDY CHAIR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

First Submitted

July 24, 2023

First Posted

August 2, 2023

Study Start

July 28, 2023

Primary Completion

December 15, 2023

Study Completion

January 15, 2024

Last Updated

August 2, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations