Neck PainNCT07722676
Comparison of Manual Assessment of Cervical Segmental Motion With Musculoskeletal Ultrasound
An observational study of Neck Pain, run by Florida Gulf Coast University at 1 site in United States.
Trial summary
A cross-sectional construct validity study was conducted to investigate the relationship between clinician-rated cervical passive intervertebral motion (PIVM) testing and ultrasound quantification of cervical interfacet motion. 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
- What is being tested?
- Passive Intervertebral Motion testing
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2025to 31 May 2026
- Phase
- Observational
- 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
Study population: asymptomatic healthy subjects
Who may be able to join
- between 18 and 65 years old
- able to read English to provide proper consent
Who cannot join
- current neck pain (>2/10 on a numerical pain rating scale)
- cervical radiculopathy, previous cervical spine surgery
- known cervical fracture or instability
- vertebrobasilar insufficiency
- systemic inflammatory disease affecting the cervical spine
- pregnancy, traumatic brain injury, concussion
- or any condition that contraindicated cervical manual examination or ultrasound imaging.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Gulf Coast University Marieb Hall 101
Fort Myers, Florida, 33965
About this study
Official title: Construct Validity of Manual Assessment of Cervical Segmental Motion: A Comparison With Musculoskeletal Ultrasound-Derived Cervical Interfacet Motion
A cross-sectional construct validity study was conducted to investigate the relationship between clinician-rated cervical passive intervertebral motion (PIVM) testing and ultrasound quantification of cervical interfacet motion. The study was designed to determine whether clinical classifications of cervical segmental mobility correspond to objectively quantified cervical intersegmental movement.
PIVM testing represents a clinician's subjective assessment of cervical segmental movement based on perceived excursion, resistance to motion, and end-feel. In contrast, dynamic musculoskeletal ultrasound (MSKUS) was used to objectively quantify cervical interfacet motion by measuring changes in interfacet distance between standardized cervical positions. Construct validity was evaluated by examining the relationship between these two measurement approaches.
- Conditions
- Neck Pain
- Being tested
- Passive Intervertebral Motion testing
- Keywords
- passive intervertebral motion, Musculoskeletal Ultrasound, interfacet motion
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Intervertebral Motion testingDiagnostic test
Manual assessment of the interfacet motion at C5-C6 facet joint
| Study group | Role | What they receive |
|---|---|---|
| Sample | asymptomatic subject group Receives: Diagnostic Test: Passive Intervertebral Motion testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interfacet motion
Interfacet motion measured with MSK Ultrasound
Measured: immediate following manual assessment
Secondary outcomes (1)
Passive Intervertebral motion assessment
Manual assessment of motion
Measured: immediate after primary outcome measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start2 Feb 2025
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Gulf Coast University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rob Sillevis,, Florida Gulf Coast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722676
- Sponsor's protocol ID
- 2025-07
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construct Validity of Manual Assessment of Cervical Segmental Motion: A Comparison With Musculoskeletal Ultrasound-Derived Cervical Interfacet Motion
- ClinicalTrials.gov ID
- NCT07722676
- Acronym / sponsor ID
- 2025-07
- Conditions
- Neck Pain
- Keywords
- passive intervertebral motion, Musculoskeletal Ultrasound, interfacet motion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Florida Gulf Coast UniversityUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 23 Jul 2026 (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.
A cross-sectional construct validity study was conducted to investigate the relationship between clinician-rated cervical passive intervertebral motion (PIVM) testing and ultrasound quantification of cervical interfacet motion. The study was designed to determine whether clinical classifications of cervical segmental mobility correspond to objectively quantified cervical intersegmental movement.
PIVM testing represents a clinician's subjective assessment of cervical segmental movement based on perceived excursion, resistance to motion, and end-feel. In contrast, dynamic musculoskeletal ultrasound (MSKUS) was used to objectively quantify cervical interfacet motion by measuring changes in interfacet distance between standardized cervical positions. Construct validity was evaluated by examining the relationship between these two measurement approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample | – | Diagnostic Test: Passive Intervertebral Motion testingasymptomatic subject group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- asymptomatic healthy subjects
Key inclusion criteria (2 listed)
- between 18 and 65 years old
- able to read English to provide proper consent
Key exclusion criteria (7 listed)
- current neck pain (>2/10 on a numerical pain rating scale)
- cervical radiculopathy, previous cervical spine surgery
- known cervical fracture or instability
- vertebrobasilar insufficiency
- systemic inflammatory disease affecting the cervical spine
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 |
|---|---|---|
| Passive Intervertebral Motion testingManual assessment of the interfacet motion at C5-C6 facet joint | Diagnostic test | Sample |
Primary outcome
Interfacet motion
Time frame: immediate following manual assessment
Interfacet motion measured with MSK Ultrasound
1 secondary outcome
Passive Intervertebral motion assessment
Time frame: immediate after primary outcome measure
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 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain, run by Florida Gulf Coast University at 1 site in United States.
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 2 inclusion and 7 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 27 Jul 2026. 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 United States. 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?
Interfacet motion (time frame: immediate following manual assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2026.