Neck PainCEET/IRMNCT06595927
Clinical Signs and Changes in Cervical Muscles Activity Evaluated by Magnetic Resonance Imaging During an Endurance Test
A study testing Cervical extensor endurance test in people with Neck Pain and Motor Activity, run by David Colman at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Motor Activity
- What is being tested?
- Cervical extensor endurance test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- fibromyalgia, cervical radiculopathy, previous cervical surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Neck Pain, Motor Activity
- Being tested
- Cervical extensor endurance test
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical extensor endurance testDiagnostic test
Also called cervical flexor muscles motor control tests, balance test, cervical proprioception test
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Cervical extensor endurance test |
| Participants free of neck pain | Active comparator | the same experimental procedure than the other group Receives: Diagnostic Test: Cervical extensor endurance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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\&#39;s contribution during the endurance test. Each MRI scan will last 11 minutes.
Measured: 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
Measured: At baseline (just after the first MRI)
Secondary outcomes (5)
Tandem stand balance test in seconds
The participant must stand with both feet bare on the floor, aligning them so that the big toe of the back foot is in contact with the heel of the front foot, knees straight and eyes closed.
The aim is to hold this position for 30 seconds without changing feet or reopening the eyes.a stopwatch is used to evaluate this test, during 30 seconds maximum.
Measured: During the 7 days following the MRI
Cervical joint position sense error test in millimetres
The participant sits on a chair with a backrest, a helmet with a laser pointing forward is placed on his head.
A target is placed in front of him/her, against a wall 90 cm from the participant's forehead, so that the laser points to the centre of the target when the participant is in a comfortable neutral position.
The participant's ability to reposition himself in this neutral position is assessed by asking him to perform 6 successive movements of left, right rotation, flexion and then extension, before returning to the centre of the target, as close as possible to the starting position. These movements will all be performed with the eyes closed.
The offset between the return position and the starting position will be assessed by measuring the distance in millimetres from the centre of the target to the return position of the laser.
The next movement will only be performed after a return to the neutral position, performed passively by the experimenter.
Measured: During the 7 days following the MRI
Head lift test in seconds
The participant lies on his or her back with arms at his or her side and knees bent so that the feet are flat on the examination table, without a pillow.
The examiner places a two-finger thickness between the participant's external occipital protuberance and the table.
The participant is asked to perform maximum craniocervical flexion combined with cervical and cervicothoracic global flexion in order to touch the examiner's fingers under the head.
He must maintain the position as long as possible, without rising or falling and without losing the cranio-cervical flexion position. The test is therefore measured in seconds with a stopwatch. The longer the duration, the better.
Measured: During the 7 days following the MRI
Cranio-cervical flexion test in mmHg
The participant lies on his back with arms at his sides The test tool, a Stabilizer, is folded in 3 layers and placed just below the sub-occipital ridges and inflated so that the needle reads 20 mmHg in the starting position The participant is asked to actively perform a slow, measured craniocervical flexion so that he can reach the following graduations successively over a period of 2 to 3 seconds: 22 mmHg, 24 mmHg, 26 mmHg, 28 mmHg and 30 mmHg, starting each trial at 20 mmHg. The higher the level reached correctly, the better.
The test stops when the participant: fails to reach/hold the required level for 2 - 3 seconds, performs a retraction movement to reach the required level, performs a thoracic extension to reach the required level or uses superficial cervical muscle activity (sternocleidomastoid, anterior scalene) to reach the required level. In this case, the last stop (in mmHg) reached correctly is taken as an indicator of the level of performance for this test.
Measured: During the 7 days following the MRI
Endurance in cranio-cervical flexion test (in percent)
The participant lies on his or her back with arms at his sides. The test tool, the Stabilizer, and placed just below the sub-occipital ridges and inflated so that the needle reads 20 mmHg in the starting position The participant is asked to actively perform a slow craniocervical flexion in order to realize 10 repetitions of 10 seconds each, at the following pressure levels: 22, 24, 26, 28 and 30 mmHg The higher the level reached correctly, the better. The test stops when the participant: fails to reach/hold the required pressure level for 10 seconds, performs a retraction movement/ thoracic extension/ uses superficial cervical muscle (sternocleidomastoid, anterior scalene) activity to reach the required pressure level. In this case, the number of repetitions correctly performed at the last level reached are used to assess the performance as follow: each successful repetition has a value of 2%, reaching 100% at the 10th repetition performed at 30 mmHg.
Measured: During the 7 days following the MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Nov 2024
- Primary completion31 Jan 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Colman
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liege
- Responsible party
- Sponsor-investigator, David Colman, University of Liege
- Investigators
- Marc MV Vanderthommen, Professor, Study chair, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595927
- Sponsor's protocol ID
- B7072021000028
- Acronym
- CEET/IRM
- Status last verified
- Dec 2025
- First submitted
- 23 Aug 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21415716Colman D, Pesesse P, Vanderthommen M, Cagnie B, Kempinaire G, Laurent P, Bellier P, Monseur J, Demoulin C. Cervical muscle activation in response to an extensor endurance test in individuals with and without neck pain: a muscle functional magnetic resonance imaging study. Musculoskelet Sci Pract. 2026 Apr;82:103522. doi: 10.1016/j.msksp.2026.103522. Epub 2026 Feb 18.
PubMed 41722372
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06595927
- Acronym / sponsor ID
- CEET/IRM / B7072021000028
- Conditions
- Neck Pain, Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- David ColmanUniversity, hospital or other
- Collaborators
- University of Liege
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with chronic neck pain | Experimental | Diagnostic Test: Cervical extensor endurance testBoth 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 comparator | Diagnostic Test: Cervical extensor endurance testthe same experimental procedure than the other group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- fibromyalgia, cervical radiculopathy, previous cervical surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical extensor endurance testAlso: cervical flexor muscles motor control tests, balance test, cervical proprioception testMonitoring 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 | Diagnostic test | Participants free of neck pain, Participants with chronic neck pain |
Primary outcome
Change of Cervical muscles metabolism by the transverse relaxation time (T2) values in milliseconds
Time frame: At baseline and after the endurance test, to assess the change of T2 values
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\&#39;s contribution during the endurance test. Each MRI scan will last 11 minutes.
Head and neck movements in degrees or millimetres during the cervical extensor endurance test.
Time frame: At baseline (just after the first MRI)
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
5 secondary outcomes
Tandem stand balance test in seconds
Time frame: During the 7 days following the MRI
Cervical joint position sense error test in millimetres
Time frame: During the 7 days following the MRI
Head lift test in seconds
Time frame: During the 7 days following the MRI
Cranio-cervical flexion test in mmHg
Time frame: During the 7 days following the MRI
Endurance in cranio-cervical flexion test (in percent)
Time frame: During the 7 days following the MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 21415716Cagnie 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.
- Derived from this study: PubMed 41722372Colman D, Pesesse P, Vanderthommen M, Cagnie B, Kempinaire G, Laurent P, Bellier P, Monseur J, Demoulin C. Cervical muscle activation in response to an extensor endurance test in individuals with and without neck pain: a muscle functional magnetic resonance imaging study. Musculoskelet Sci Pract. 2026 Apr;82:103522. doi: 10.1016/j.msksp.2026.103522. Epub 2026 Feb 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc MV Vanderthommen, Professor study chair
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical extensor endurance test in people with Neck Pain and Motor Activity, run by David Colman at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Cervical muscles metabolism by the transverse relaxation time (T2) values in milliseconds (time frame: At baseline and after the endurance test, to assess the change of T2 values). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06595927, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.