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Quantitative Ultrasound + Osteopathic Therapy for Chronic Neck Pain
N/A
Waitlist Available
Led By Jing Gao, MD
Research Sponsored by Rocky Vista University, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For healthy participants: No history of musculoskeletal conditions, such as severe pain, trauma, joint or spine surgery
For patients with chronic neck pain: Having chronic neck pain persisting longer than 12 weeks, meeting TART criteria, diagnosed by an osteopathic physician
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow- up. up to 18 weeks after procedure.
Awards & highlights
Study Summary
This trial is testing whether changes in physical properties of muscles can be used to identify and manage chronic neck pain.
Who is the study for?
This trial is for adults over 18 with chronic neck pain lasting more than 12 weeks, diagnosed by an osteopathic physician. Healthy participants without musculoskeletal issues can also join. All must consent to the study and tolerate exams and ultrasound. Employees of investigators or those unable to consent (e.g., mental disability) are excluded.Check my eligibility
What is being tested?
The study tests how well new ultrasound biomarkers can assess muscle condition in the upper trapezius and monitor treatment progress in individuals with chronic neck pain using Osteopathic TART Assessment, Quantitative Ultrasound, and Osteopathic Manipulation Treatment.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort from the osteopathic exam or manipulation treatment, as well as possible skin irritation or mild pain from the ultrasound procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have no history of severe musculoskeletal issues or surgeries on my joints or spine.
Select...
I have had neck pain for more than 12 weeks, diagnosed by an osteopathic doctor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ follow- up. up to 18 weeks after procedure.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow- up. up to 18 weeks after procedure.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ultrasound diagnostic performance evaluation
Secondary outcome measures
Ultrasound echo-intensity
Ultrasound longitudinal strain ratios
Ultrasonography
Trial Design
2Treatment groups
Experimental Treatment
Group I: Patients with chronic neck painExperimental Treatment3 Interventions
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.
Group II: Healthy participantsExperimental Treatment2 Interventions
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.
Find a Location
Who is running the clinical trial?
Rocky Vista University, LLCLead Sponsor
1 Previous Clinical Trials
80 Total Patients Enrolled
American Osteopathic AssociationOTHER
19 Previous Clinical Trials
3,557 Total Patients Enrolled
Jing Gao, MDPrincipal InvestigatorRocky Vista University
2 Previous Clinical Trials
240 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old and healthy.My chronic neck pain is due to a late-stage or unstable condition.I am 18 or older with chronic neck pain.I cannot tolerate certain neck pain examinations or treatments.I have a history of bone, joint, or spine issues or surgeries.I have no history of severe musculoskeletal issues or surgeries on my joints or spine.I have had neck pain for more than 12 weeks, diagnosed by an osteopathic doctor.I am under 18 and have chronic neck pain.I can sign a consent form for my chronic neck pain treatment.I can undergo osteopathic exams and treatments for my chronic neck pain.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with chronic neck pain
- Group 2: Healthy participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any individuals presently being accepted into this research project?
"This study, which was first posted on August 24th 2022 and last adjusted the same day, is not actively recruiting patients. However, there are 90 other experiments that are presently looking for participants to join in their research."
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