- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07722676
Comparison of Manual Assessment of Cervical Segmental Motion With Musculoskeletal Ultrasound
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
-
Fort Myers, Florida, United States, 33965
- Florida Gulf Coast University Marieb Hall 101
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
asymptomatic healthy subjects
Description
Inclusion Criteria:
- between 18 and 65 years old
- able to read English to provide proper consent
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: CROSS_SECTIONAL
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Sample
asymptomatic subject group |
Manual assessment of the interfacet motion at C5-C6 facet joint |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interfacet motion
Time Frame: immediate following manual assessment
|
Interfacet motion measured with MSK Ultrasound |
immediate following manual assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Passive Intervertebral motion assessment
Time Frame: immediate after primary outcome measure
|
Manual assessment of motion |
immediate after primary outcome measure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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