Back PainNCT07858071
Use of Ultrasound Imaging in Confirming Osteopathic Spinal Diagnosis
An observational study of Back Pain and Back Pain Lower Back, run by The Touro College and University System at 1 site in United States.
Trial summary
In the field of Osteopathic Medicine, diagnosis of potential areas of dysfunction are diagnosed by the physician using their hands and expertise in noticing subtle differences in symmetry, tone, swelling etc.. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Back Pain, Back Pain Lower Back, Back Pain Lower Back Chronic
- What is being tested?
- Spinal Ultrasound
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to 7 Aug 2026
- Phase
- Observational
- 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
Study population: Patients of Dr. Leonid Tafler's private practice
Who may be able to join
- patients found to have somatic dysfunction on palpation of the spine
Who cannot join
- patients that decline participation, otherwise no exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Leonid Tafler DO Osteopathic Medical Treatment
Brooklyn, New York, 11210
About this study
Official title: Investigating Use of Musculoskeletal Ultrasound in Conjunction With Manual Somatic Dysfunction Diagnosis
In the field of Osteopathic Medicine, diagnosis of potential areas of dysfunction are diagnosed by the physician using their hands and expertise in noticing subtle differences in symmetry, tone, swelling etc.. In this study, we propose the use of ultrasound, which is a non invasive imaging technique that requires no radiation exposure, to confirm the diagnosis made with the physician's hands. We believe this will add a layer of objectivity to this diagnosis, in that you have numbers that have been measured to back up the diagnosis made based on feel. In this study, we can confirm whether or not these differences felt are true from an objective standpoint. We will compare patients with dysfunction palpated on manual exam to those with no palpated dysfunction in terms of their median asymmetry when measured using musculoskeletal ultrasound.
- Conditions
- Back Pain, Back Pain Lower Back, Back Pain Lower Back Chronic, Back Pain With Radiation, Somatic Dysfunction of Lumbar Spine
- Being tested
- Spinal Ultrasound
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal UltrasoundDiagnostic test
Patient will undergo transverse spinal ultrasound of the spinal segment of interest, and the image taken will be measured for the distance from the facet joint on each side to the skin. The absolute value of the difference between these measurements is then recorded as the measured asymmetry.
| Study group | Role | What they receive |
|---|---|---|
| Palpated somated dysfuncion | Patients in this group would be those who were palpated by the Osteopathic Physician and found to have an identifiable somatic dysfunction of the spine on manual exam. These patients then immediately undergo spinal ultrasound to confirm whether or not there is measured asymmetry in the spine. Receives: Diagnostic Test: Spinal Ultrasound | |
| No Palpated Somatic Dysfunction | Patients with no somatic dysfunction palpated by the osteopathic physician on initial manual examination. Receives: Diagnostic Test: Spinal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured Asymmetry
This is the absolute value of the difference between the measured distance from the left facet joint to the skin, and the right facet joint to the skin. This measurement is obtained from a transverse ultrasound image using the caliper function on the ultrasound machine.
Measured: Single measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start18 Mar 2026
- Primary completion26 Jun 2026
- Study completion7 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Touro College and University System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikhail Volokitin, MD, DO., The Touro College and University System
- Investigators
- Mikhail Volokitin, DO, Principal investigator, Touro College of Osteopathic Medicine - Harlem, NY Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858071
- Sponsor's protocol ID
- 28463
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Use of Musculoskeletal Ultrasound in Conjunction With Manual Somatic Dysfunction Diagnosis
- ClinicalTrials.gov ID
- NCT07858071
- Acronym / sponsor ID
- 28463
- Conditions
- Back Pain, Back Pain Lower Back, Back Pain Lower Back Chronic, Back Pain With Radiation, Somatic Dysfunction of Lumbar Spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The Touro College and University SystemUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 7 Aug 2026 (actual)
- First posted
- 5 Oct 2026 (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.
In the field of Osteopathic Medicine, diagnosis of potential areas of dysfunction are diagnosed by the physician using their hands and expertise in noticing subtle differences in symmetry, tone, swelling etc.. In this study, we propose the use of ultrasound, which is a non invasive imaging technique that requires no radiation exposure, to confirm the diagnosis made with the physician's hands. We believe this will add a layer of objectivity to this diagnosis, in that you have numbers that have been measured to back up the diagnosis made based on feel. In this study, we can confirm whether or not these differences felt are true from an objective standpoint. We will compare patients with dysfunction palpated on manual exam to those with no palpated dysfunction in terms of their median asymmetry when measured using musculoskeletal ultrasound.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palpated somated dysfuncion | – | Diagnostic Test: Spinal UltrasoundPatients in this group would be those who were palpated by the Osteopathic Physician and found to have an identifiable somatic dysfunction of the spine on manual exam. These patients then immediately undergo spinal ultrasound to confirm whether or not there is measured asymmetry in the spine. |
| No Palpated Somatic Dysfunction | – | Diagnostic Test: Spinal UltrasoundPatients with no somatic dysfunction palpated by the osteopathic physician on initial manual examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Dr. Leonid Tafler's private practice
Key inclusion criteria (1 listed)
- patients found to have somatic dysfunction on palpation of the spine
Key exclusion criteria (1 listed)
- patients that decline participation, otherwise no exclusion criteria
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 |
|---|---|---|
| Spinal UltrasoundPatient will undergo transverse spinal ultrasound of the spinal segment of interest, and the image taken will be measured for the distance from the facet joint on each side to the skin. The absolute value of the difference between these measurements is then recorded as the measured asymmetry. | Diagnostic test | No Palpated Somatic Dysfunction, Palpated somated dysfuncion |
Primary outcome
Measured Asymmetry
Time frame: Single measurement
This is the absolute value of the difference between the measured distance from the left facet joint to the skin, and the right facet joint to the skin. This measurement is obtained from a transverse ultrasound image using the caliper function on the ultrasound machine.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
Related trials for Back Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
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.
Mikhail Volokitin, DO principal investigator
Touro College of Osteopathic Medicine - Harlem, NY Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain and Back Pain Lower Back, run by The Touro College and University System 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measured Asymmetry (time frame: Single measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.