NCT06595927

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

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

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

August 23, 2022

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

August 23, 2022

Last Update Submit

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

EXPERIMENTAL

Both 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

Diagnostic Test: Cervical extensor endurance test

Participants free of neck pain

ACTIVE COMPARATOR

the same experimental procedure than the other group

Diagnostic Test: Cervical extensor endurance test

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

Also known as: cervical flexor muscles motor control tests, balance test, cervical proprioception test
Participants free of neck painParticipants with chronic neck pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

University Hospital of Liege

Liège, Liège, 4000, Belgium

Location

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

Neck PainMotor Activity

Interventions

Recruitment Detection, Audiologic

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Hearing TestsDiagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Marc MV Vanderthommen, Professor

    University of Liege

    STUDY CHAIR

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

Locations