NCT05933590

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

June 28, 2023

Last Update Submit

January 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Study Arms (2)

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.

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.

Diagnostic Test: Cervical Joint Repositioning Error Assessment

Interventions

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.

Chronic Migraine GroupControl Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes individuals aged 18-65 years old, with and without chronic migraine.

You may qualify if:

  • Individuals aged 18-65 years old
  • Diagnosis of chronic migraine (for the chronic migraine group)
  • No history of migraine (for the control group)

You may not qualify if:

  • History of cervical spine pathology
  • Neurological deficits unrelated to migraine
  • Current pregnancy

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

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Amal Fawzy, Ph.d

    Faculty of Physical Therapy, Ahram Canadian University

    STUDY CHAIR

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

June 28, 2023

First Posted

July 6, 2023

Study Start

July 1, 2023

Primary Completion

January 6, 2024

Study Completion

January 6, 2024

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations