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Quantitative Ultrasound Biomarkers to Assess Upper Trapezius Muscles in Patients With Chronic Pain

NCT05497622 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-08-25

No results posted yet for this study

Summary

The goal of this study is to identify and develop multiparametric quantitative ultrasound imaging (QUI) biomarkers for assessing upper trapezius muscle with and without chronic neck pain and their response to treatment. This goal will be achieved by testing the underlying hypothesis that abnormal muscle tissue can be identified based on its physio-mechanical properties, and that changes in these properties can be used to guide and monitor treatment progress. Preliminary results have shown that biomarkers including muscle B-mode ultrasound echo-intensity, shear wave velocity, and longitudinal strain ratios associated with muscle tissue structure, mechanics, and function significantly differ between muscles in low back pain and neuromuscular disorders and normal muscles. This study will determine which biomarkers are best suited to differentiate abnormal muscle in chronic neck pain from healthy muscles and develop a quantitative objective program for chronic neck pain management.

Conditions

  • Chronic Neck Pain

Interventions

DIAGNOSTIC_TEST

Quantitative Ultrasound

Ultrasound assessment of Trapezius muscle

DIAGNOSTIC_TEST

Osteopathic TART Assessment

Evaluation of the 4 diagnostic criteria: 1. Tissue Texture abnormality 2. Asymmetry 3. Restriction of Motion 4. Tenderness

PROCEDURE

Osteopathic Manipulation Treatment

Use of manual techniques such as soft tissue stretching, resisted isometric stretches, fascial relaxation and counter strain.

Sponsors & Collaborators

  • American Osteopathic Association

    collaborator OTHER

  • Rocky Vista University, LLC

    lead OTHER

Principal Investigators

  • Jing Gao, MD · Rocky Vista University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-24
Primary Completion
2024-03-31
Completion
2024-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05497622 on ClinicalTrials.gov