Chronic Neck PainNCT05497622
Quantitative Ultrasound Biomarkers to Assess Upper Trapezius Muscles in Patients With Chronic Pain
A study testing Quantitative Ultrasound, Osteopathic TART Assessment and Osteopathic Manipulation Treatment in people with Chronic Neck Pain, run by Rocky Vista University, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Quantitative Ultrasound, Osteopathic TART Assessment and Osteopathic Manipulation Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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:
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Neck Pain
- Being tested
- Quantitative Ultrasound, Osteopathic TART Assessment, Osteopathic Manipulation Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative UltrasoundDiagnostic test
Also called QUI
Ultrasound assessment of Trapezius muscle
Osteopathic TART AssessmentDiagnostic test
Also called TART
Evaluation of the 4 diagnostic criteria:
- Tissue Texture abnormality
- Asymmetry
- Restriction of Motion
- Tenderness
Osteopathic Manipulation TreatmentProcedure or surgery
Also called OMT
Use of manual techniques such as soft tissue stretching, resisted isometric stretches, fascial relaxation and counter strain.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Quantitative Ultrasound; Diagnostic Test: Osteopathic TART Assessment; Procedure: Osteopathic Manipulation Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after the intervention
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow- up. Up to 18 weeks after procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start24 Aug 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rocky Vista University, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Association
- Responsible party
- Sponsor
- Investigators
- Jing Gao, MD, Principal investigator, Rocky Vista University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497622
- Sponsor's protocol ID
- IRB #2022--095
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified data will be available with reasonable request to principal investigator.
Publications
Gao J, Lynch E, Coleman M, Moore J, Park D, Wilde B. Ultrasound shear wave elastography to assess neck somatic dysfunction and OMT effects. J Osteopath Med. 2025 Jul 1;125(12):589-599. doi: 10.1515/jom-2024-0236. eCollection 2025 Dec 1.
PubMed 40583618
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Ultrasound Biomarkers to Assess Upper Trapezius Muscles in Patients With Chronic Neck Pain Before and After Osteopathic Manipulative Treatment
- ClinicalTrials.gov ID
- NCT05497622
- Acronym / sponsor ID
- IRB #2022--095
- Conditions
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Rocky Vista University, LLCUniversity, hospital or other
- Collaborators
- American Osteopathic Association
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Experimental | Diagnostic Test: Quantitative Ultrasound, Diagnostic Test: Osteopathic TART AssessmentNon-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. |
| Patients with chronic neck pain | Experimental | Diagnostic Test: Quantitative Ultrasound, Diagnostic Test: Osteopathic TART Assessment, Procedure: Osteopathic Manipulation TreatmentNon-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative UltrasoundAlso: QUIUltrasound assessment of Trapezius muscle | Diagnostic test | Healthy participants, Patients with chronic neck pain |
| Osteopathic TART AssessmentAlso: TARTEvaluation of the 4 diagnostic criteria: 1. Tissue Texture abnormality 2. Asymmetry 3. Restriction of Motion 4. Tenderness | Diagnostic test | Healthy participants, Patients with chronic neck pain |
| Osteopathic Manipulation TreatmentAlso: OMTUse of manual techniques such as soft tissue stretching, resisted isometric stretches, fascial relaxation and counter strain. | Procedure or surgery | Patients with chronic neck pain |
Primary outcome
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.
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.
9 secondary outcomes
Ultrasound echo-intensity
Time frame: Baseline, pre-intervention
Ultrasound echo-intensity
Time frame: Immediately after the intervention
Ultrasound echo-intensity
Time frame: Follow- up. Up to 18 weeks after procedure.
Ultrasound shear wave velocity
Time frame: Baseline, pre-intervention
Ultrasound shear wave velocity
Time frame: Immediately after the intervention
Ultrasound shear wave velocity
Time frame: Follow- up. Up to 18 weeks after procedure.
Ultrasound longitudinal strain ratios
Time frame: Baseline, pre-intervention
Ultrasound longitudinal strain ratios
Time frame: Immediately after the intervention
Ultrasound longitudinal strain ratios
Time frame: Follow- up. Up to 18 weeks after procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Derived from this study: PubMed 40583618Gao J, Lynch E, Coleman M, Moore J, Park D, Wilde B. Ultrasound shear wave elastography to assess neck somatic dysfunction and OMT effects. J Osteopath Med. 2025 Jul 1;125(12):589-599. doi: 10.1515/jom-2024-0236. eCollection 2025 Dec 1.
- Individual participant dataSharing planned: No. De-identified data will be available with reasonable request to principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Gao, MD principal investigator
Rocky Vista University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative Ultrasound, Osteopathic TART Assessment and Osteopathic Manipulation Treatment in people with Chronic Neck Pain, run by Rocky Vista University, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound diagnostic performance evaluation (time frame: Baseline, pre-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05497622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.