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

NCT05497622 | Unknown FDA Device

• 1 other identifier: IRB #2022--095
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Ultrasound echo-intensity

  Baseline, pre-intervention

• Ultrasound echo-intensity

  Immediately after the intervention

• Ultrasound echo-intensity

  Follow- up. Up to 18 weeks after procedure.

• Ultrasound shear wave velocity

  Baseline, pre-intervention

• Ultrasound shear wave velocity

  Immediately after the intervention

Study Arms (2)

Healthy participants

EXPERIMENTAL

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; Diagnostic Test: Osteopathic TART Assessment

Patients with chronic neck pain

EXPERIMENTAL

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; Diagnostic Test: Osteopathic TART Assessment; Procedure: Osteopathic Manipulation Treatment

Interventions

Quantitative Ultrasound DIAGNOSTIC_TEST

Ultrasound assessment of Trapezius muscle

Also known as: QUI

Healthy participants; Patients with chronic neck pain

Osteopathic TART Assessment DIAGNOSTIC_TEST

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

Also known as: TART

Healthy participants; Patients with chronic neck pain

Osteopathic Manipulation Treatment PROCEDURE

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

Also known as: OMT

Patients with chronic neck pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Rocky Vista University, LLC: lead
• American Osteopathic Association: collaborator

Study Sites (1)

Ultrasound Research Laboratory

Ivins, Utah, 84738, United States

Location

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Jing Gao, MD

  Rocky Vista University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups will be used in the study to evaluate Quantitative Ultrasound Imaging (QUI) biomarkers and TART assessments. 1. 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 controls one time at the time of the enrollment. 2. Patients with chromic 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.

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 11, 2022
• Study Start: August 24, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)