Quantitative Ultrasound Biomarkers to Assess Upper Trapezius Muscles in Patients With Chronic Pain
NCT ID: NCT05497622
Last Updated: 2022-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
108 participants
INTERVENTIONAL
2022-08-24
2024-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
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.
DIAGNOSTIC
NONE
Study Groups
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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.
Quantitative Ultrasound
Ultrasound assessment of Trapezius muscle
Osteopathic TART Assessment
Evaluation of the 4 diagnostic criteria:
1. Tissue Texture abnormality
2. Asymmetry
3. Restriction of Motion
4. Tenderness
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.
Quantitative Ultrasound
Ultrasound assessment of Trapezius muscle
Osteopathic TART Assessment
Evaluation of the 4 diagnostic criteria:
1. Tissue Texture abnormality
2. Asymmetry
3. Restriction of Motion
4. Tenderness
Osteopathic Manipulation Treatment
Use of manual techniques such as soft tissue stretching, resisted isometric stretches, fascial relaxation and counter strain.
Interventions
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Quantitative Ultrasound
Ultrasound assessment of Trapezius muscle
Osteopathic TART Assessment
Evaluation of the 4 diagnostic criteria:
1. Tissue Texture abnormality
2. Asymmetry
3. Restriction of Motion
4. Tenderness
Osteopathic Manipulation Treatment
Use of manual techniques such as soft tissue stretching, resisted isometric stretches, fascial relaxation and counter strain.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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American Osteopathic Association
OTHER
Rocky Vista University, LLC
OTHER
Responsible Party
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Principal Investigators
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Jing Gao, MD
Role: PRINCIPAL_INVESTIGATOR
Rocky Vista University
Locations
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Ultrasound Research Laboratory
Ivins, Utah, United States
Countries
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Other Identifiers
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IRB #2022--095
Identifier Type: -
Identifier Source: org_study_id
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