NCT07722676

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2025

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

Study Start

First participant enrolled

February 2, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

July 20, 2026

Last Update Submit

July 24, 2026

Conditions

Keywords

passive intervertebral motionMusculoskeletal Ultrasoundinterfacet motion

Outcome Measures

Primary Outcomes (1)

  • Interfacet motion

    Interfacet motion measured with MSK Ultrasound

    immediate following manual assessment

Secondary Outcomes (1)

  • Passive Intervertebral motion assessment

    immediate after primary outcome measure

Study Arms (1)

Sample

asymptomatic subject group

Diagnostic Test: Passive Intervertebral Motion testing

Interventions

Manual assessment of the interfacet motion at C5-C6 facet joint

Sample

Eligibility Criteria

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

asymptomatic healthy subjects

You may qualify if:

  • between 18 and 65 years old
  • able to read English to provide proper consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Gulf Coast University Marieb Hall 101

Fort Myers, Florida, 33965, United States

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 23, 2026

Study Start

February 2, 2025

Primary Completion

May 31, 2026

Study Completion

May 31, 2026

Last Updated

July 27, 2026

Record last verified: 2026-07

Locations