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

August 24, 2022 updated by: Rocky Vista University, LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:

  1. Tissue Texture abnormality
  2. Asymmetry
  3. Restriction of Motion
  4. 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:

  1. Tissue Texture abnormality
  2. Asymmetry
  3. Restriction of Motion
  4. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ultrasound diagnostic performance evaluation
Time Frame: Baseline, pre-intervention

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
Time Frame: Immediately after the intervention

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ultrasound echo-intensity
Time Frame: Baseline, pre-intervention

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
Time Frame: Immediately after the intervention

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
Time Frame: Follow- up. Up to 18 weeks after procedure.

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
Time Frame: Baseline, pre-intervention
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
Time Frame: Immediately after the intervention
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
Time Frame: Follow- up. Up to 18 weeks after procedure.
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
Time Frame: Baseline, pre-intervention
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
Time Frame: Immediately after the intervention
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
Time Frame: Follow- up. Up to 18 weeks after procedure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rocky Vista University, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Osteopathic Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jing Gao, MD, Rocky Vista University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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