Quantitative Ultrasound Biomarkers to Assess Upper Trapezius Muscles in Patients With Chronic Pain
Unknown statusNot applicableNCT05497622
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Quantitative Ultrasound Biomarkers to Assess Upper Trapezius Muscles in Patients With Chronic Neck Pain Before and After Osteopathic Manipulative Treatment
- Conditions
- Interventions
- Diagnostic test: Quantitative Ultrasound
- Diagnostic test: Osteopathic TART Assessment
- Procedure: Osteopathic Manipulation Treatment
- Sponsor
- Rocky Vista University, LLC
- Collaborators
- American Osteopathic Association
- Start date
- 2022-08-24
- Primary completion
- 2024-03-31
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05497622