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

Quantitative Ultrasound Biomarkers to Assess Upper Trapezius Muscles in Patients With Chronic Neck Pain Before and After Osteopathic Manipulative Treatment

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Neck Pain
• Intervention / Treatment: Diagnostic test: Quantitative Ultrasound; Diagnostic test: Osteopathic TART Assessment; Procedure: Osteopathic Manipulation Treatment

Detailed Description

The main objective will be achieved through two aims:

Aim 1: Identify and develop quantitative biomarkers to distinguish structure, mechanics, function, and blood flow in abnormal muscles associated with chronic neck pain from normal muscles, correlated with clinical osteopathic assessments.

To determine the diagnostic performances of echo-intensity as a muscle structural biomarker, shear wave velocity and longitudinal strain ratio as muscle mechanics/function biomarkers, and color Doppler microvascular index as a muscle blood flow biomarker will be evaluated. These assessments will be evaluated in healthy subjects to test these quantitative biomarkers on upper trapezius muscle in the neck region to establish normal control values. To determine the clinical utility of these novel biomarkers, subjects with chronic neck pain will receive clinical osteopathic assessments over the neck region using conventional osteopathic examination with qualitative disease scoring by clinicians and subjective pain scales by subjects. The above quantitative biomarkers and qualitative osteopathic assessments of corresponding tissues with and without chronic neck pain will be analyzed using advanced ultrasound processing methods and statistical analyses.

Aim 2: Evaluate the abilities of quantitative biomarkers developed in Aim 1 to assess the responses of muscle tissue structure, mechanics, function, and blood flow to osteopathic manipulative treatment (OMT) for chronic neck pain.

To determine the prognostic performance of the QUI biomarkers developed in Aim 1 in predicting clinical response to OMT treatment, it will demonstrate that abnormal muscle tissue physio-mechanical properties to be directly linked to the pain of the patients. This trial will determine if improvement in abnormal biomarker values leads to improvement in subject's pain and osteopathic assessments. Subjects with chronic neck pain will be examined at intervals with biomarker measurements and osteopathic assessments. Image processing and statistical analysis will be used to determine the performance of the biomarkers in predicting response to treatment. the approach used in this study is supported by preliminary studies, which show how ultrasound biomarkers change following OMT, returning toward more normal muscle tissue mechanics.

This clinical trial will validate at least one clinically useful prognostic biomarker for chronic neck pain management, lay the foundation for further clinical research and treatment based on quantitative, reproducible, well-established methods, and lead to a large grant application.

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Ivins, Utah, United States, 84738
      • Ultrasound Research Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Inclusion criteria for the healthy participants include:

• Age 18 years and older;
• Healthy. No history of musculoskeletal conditions, such as severe pain, trauma, joint or spine surgery;
• Able to sign written informed consent,
• Tolerant to the osteopathic exam, and ultrasound.

Inclusion criteria for patients with chronic neck pain include:

• Age 18 years and older
• Having chronic neck pain persisting longer than 12 weeks, meeting TART criteria, diagnosed by an osteopathic physician;
• Able to sign written informed consent;
• Tolerant to the osteopathic exam, ultrasound, and OMT.

Exclusion Criteria:

Exclusion criteria for the healthy participants include:

• Under 18 years of age;
• Having a medical history of musculoskeletal conditions, joint and/or spine surgery, trauma;
• Employee of the study investigators;
• Being unable to competently consent or assent to participation (e.g., mentally disabled, demented, delusional, or a prisoner);
• Not tolerant to the osteopathic exam, ultrasound.

Exclusion criteria for patients with chronic neck pain include:

• Age < 18 years,
• Unable or unqualified to sign an informed consent,
• Unstable and/or late stage diseases,
• Not tolerant to the osteopathic exam, ultrasound, OMT.

There is no specific racial/ethnic background limitation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy participants; Non-invasive quantitative ultrasound (B-mode image, ultrasound elastography), EMG, and osteopathic assessment (TART assessments) will be performed on the upper trapezius muscle in healthy participants one time at the time of the enrollment.	Diagnostic test: Quantitative Ultrasound; Ultrasound assessment of Trapezius muscle; Other Names: QUI; Diagnostic test: Osteopathic TART Assessment; Evaluation of the 4 diagnostic criteria: Tissue Texture abnormality; Asymmetry; Restriction of Motion; Tenderness; Other Names: TART
Experimental: Patients with chronic neck pain; Non-invasive quantitative ultrasound (B-mode ultrasound, ultrasound elastography), EMG, osteopathic assessment, and osteopathic manipulative treatment (OMT) of the upper trapezius muscle will be performed on participants with chronic neck pain 3 times. All ultrasound, EMG biomarkers and TART assessments will be collected before and after OMT.	Diagnostic test: Quantitative Ultrasound; Ultrasound assessment of Trapezius muscle; Other Names: QUI; Diagnostic test: Osteopathic TART Assessment; Evaluation of the 4 diagnostic criteria: Tissue Texture abnormality; Asymmetry; Restriction of Motion; Tenderness; Other Names: TART; Procedure: Osteopathic Manipulation Treatment; Use of manual techniques such as soft tissue stretching, resisted isometric stretches, fascial relaxation and counter strain.; Other Names: OMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound diagnostic performance evaluation	Evaluation for healthy participants and for patients with chronic neck pain. Changes in muscle B-mode ultrasound echo-intensity (arbitrary units), shear wave velocity (m/s), and longitudinal strain ratios (arbitrary units) will be recorded. Measured using ultrasound.	Baseline, pre-intervention
Ultrasound diagnostic performance evaluation	Evaluation for patients with chronic neck pain. Changes in muscle B-mode ultrasound echo-intensity (arbitrary units), shear wave velocity (m/s), and longitudinal strain ratios (arbitrary units) will be recorded. Measured using ultrasound.	Immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound echo-intensity	Evaluation for healthy participants and for patients with chronic neck pain. Changes in muscle B-mode ultrasound echo-intensity (arbitrary units) will be recorded. Measured using ultrasound.	Baseline, pre-intervention
Ultrasound echo-intensity	Evaluation for patients with chronic neck pain. Changes in muscle B-mode ultrasound echo-intensity (arbitrary units) will be recorded. Measured using ultrasound.	Immediately after the intervention
Ultrasound echo-intensity	Evaluation for patients with chronic neck pain. Changes in muscle B-mode ultrasound echo-intensity (arbitrary units) will be recorded. Measured using ultrasound.	Follow- up. Up to 18 weeks after procedure.
Ultrasound shear wave velocity	Evaluation for healthy participants and for patients with chronic neck pain. Changes in shear wave velocity (m/s), will be recorded. Measured using ultrasound.	Baseline, pre-intervention
Ultrasound shear wave velocity	Evaluation for patients with chronic neck pain. Changes in shear wave velocity (m/s), will be recorded. Measured using ultrasound.	Immediately after the intervention
Ultrasound shear wave velocity	Evaluation for patients with chronic neck pain. Changes in shear wave velocity (m/s), will be recorded. Measured using ultrasound.	Follow- up. Up to 18 weeks after procedure.
Ultrasound longitudinal strain ratios	Evaluation for healthy participants and for patients with chronic neck pain. Changes in longitudinal strain ratios (arbitrary units) will be recorded. Measured using ultrasound.	Baseline, pre-intervention
Ultrasound longitudinal strain ratios	Evaluation for patients with chronic neck pain. Changes in longitudinal strain ratios (arbitrary units) will be recorded. Measured using ultrasound.	Immediately after the intervention
Ultrasound longitudinal strain ratios	Evaluation for patients with chronic neck pain. Changes in longitudinal strain ratios (arbitrary units) will be recorded. Measured using ultrasound.	Follow- up. Up to 18 weeks after procedure.

Collaborators and Investigators

• Sponsor: Rocky Vista University, LLC
• Collaborators: American Osteopathic Association
• Investigators: Principal Investigator: Jing Gao, MD, Rocky Vista University

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: IRB #2022--095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified data will be available with reasonable request to principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes