Clinical Signs and Changes in Cervical Muscles Activity Evaluated by Magnetic Resonance Imaging During an Endurance Test
CEET/IRM
Comparison and Correlation of Clinical Signs With Changes in the Activity of the Cervical Muscles Evaluated by Muscle Functional Magnetic Resonance Imaging During the Cervical Cervical Extensor Endurance Test
1 other identifier
interventional
29
1 country
1
Brief Summary
The aim of this present study is to compare the radio-clinic correlation between the ability to hold the head and neck (by inertial sensor) and the changes in neck muscles activity (by functional magnetic resonance imaging) during the cervical extensor endurance test between an asymptomatic population and one suffering from chronic neck pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2024
Shorter than P25 for not_applicable
1 active site
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
August 23, 2022
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedDecember 18, 2025
December 1, 2025
3 months
August 23, 2022
December 10, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change of Cervical muscles metabolism by the transverse relaxation time (T2) values in milliseconds
The MRI, after identifying the region of interest for each muscle, will be used to calculate a transverse relaxation time (T2) value (in milliseconds) for each muscle at two assessment points: before and after the cervical extensor endurance test. The aim is to evaluate the changes in T2 values induced by each muscle\'s contribution during the endurance test. Each MRI scan will last 11 minutes.
At baseline and after the endurance test, to assess the change of T2 values
Head and neck movements in degrees or millimetres during the cervical extensor endurance test.
The inertial sensor will monitor the head and neck movements during the entire duration of the Cervical Extensor Endurance Test, in the three planes of space for cervical movements and for cranio-cervical flexion/extension movement. The maximal duration of 3 minutes of the cervical extensor endurance test
At baseline (just after the first MRI)
Secondary Outcomes (5)
Tandem stand balance test in seconds
During the 7 days following the MRI
Cervical joint position sense error test in millimetres
During the 7 days following the MRI
Head lift test in seconds
During the 7 days following the MRI
Cranio-cervical flexion test in mmHg
During the 7 days following the MRI
Endurance in cranio-cervical flexion test (in percent)
During the 7 days following the MRI
Study Arms (2)
Participants with chronic neck pain
EXPERIMENTALBoth groups will receive the same experimental procedure, divided in 2 parts. Part 1: a first cervical MRI is done, followed by a cervical extensor endurance test during 3 minutes and the second cervical MRI. Part 2 : several clinical tests will be done: * tandem stand balance test (eyes closed, firm ground) * cranio-cervical flexion test * head lift test * cervical joint position error sense test in 4 directions
Participants free of neck pain
ACTIVE COMPARATORthe same experimental procedure than the other group
Interventions
Monitoring the clinical parameters of head and neck immobility during the cervical extensor endurance test to correlate them with muscular activity by MRI and other cervical clinical tests
Eligibility Criteria
You may qualify if:
- Neck Disability Index score \> 8/50 for the symptomatic group OR \< 4/50 for the asymptomatic group
- numerical rating scale \< 7/10 for the symptomatic group
- suffering from idiopathic or traumatic chronic neck pain for the neck pain group OR being free of neck pain which required therapeutic, medical or medicinal treatment in the last 12 months.
You may not qualify if:
- fibromyalgia, cervical radiculopathy, previous cervical surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- David Colmanlead
- University of Liegecollaborator
Study Sites (1)
University Hospital of Liege
Liège, Liège, 4000, Belgium
Related Publications (1)
Cagnie B, O'Leary S, Elliott J, Peeters I, Parlevliet T, Danneels L. Pain-induced changes in the activity of the cervical extensor muscles evaluated by muscle functional magnetic resonance imaging. Clin J Pain. 2011 Jun;27(5):392-7. doi: 10.1097/AJP.0b013e31820e11a2.
PMID: 21415716BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marc MV Vanderthommen, Professor
University of Liege
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD student, Principal Investigator
Study Record Dates
First Submitted
August 23, 2022
First Posted
September 19, 2024
Study Start
November 1, 2024
Primary Completion
January 31, 2025
Study Completion
February 28, 2025
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share