Chronic Low-back PainNCT05928884
Ultrasound Imaging for Myofascial Pain
An observational study of Chronic Low-back Pain and Myofascial Pain, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of this observational study is to develop and validate a biomarker for lumbar myofascial pain (MP) based on ultrasound obtained measurements of the lumbar muscles and fascia. The investigators will use advanced machine learning approaches and validation in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain, Myofascial Pain
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 30 Sep 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators are including healthy normal and cLBP subjects from ages 20 to 70.
Who may be able to join
- No history of chronic low back pain, myofascial pain of the neck or shoulders, or fibromyalgia.
- Ages 20-70 to be age appropriate to the cLBP subjects. The investigators will recruit 10 subjects per age decile (10 subjects ages 30-39 yrs., etc.).
- Any clinically unstable systemic illness that is judged to interfere
- with the trial
- Non-ambulatory status
- Not able to complete the questionnaires.
Show all 10Show fewer
- Age range 20-70 so that the age distribution is likely to roughly match the healthy normals
- Predominantly axial cLBP meeting the NIH definition of cLBP (at least 3 months on a daily basis) with a MP component (determined by a standardized clinical exam)
- Average pain score of > 3/10, with low back pain being the primary pain site
- cLBP meeting Quebec Task Force Classification System categories I-III (from axial pain only to pain radiating beyond the knee without neurological signs).
Who cannot join
- Back surgery within the past year
- Active worker's compensation or litigation claims since these patients are more likely to have exaggerated pain behavior
- New pain treatments within 2 weeks of enrollment
- Any clinically unstable systemic illness that is judged to interfere with the trial
- Non-ambulatory status
- Not able to complete the questionnaires.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kauffman Medical Building
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Development and Validation of a Noninvasive Multimodal Ultrasound-Based Imaging Biomarker for Myofascial Pain
The goal of this observational study is to develop and validate a biomarker for lumbar myofascial pain (MP) based on ultrasound obtained measurements of the lumbar muscles and fascia. The investigators will use advanced machine learning approaches and validation in a randomized controlled trial. The main questions it aims to answer are:
- Will the deep learning-based marker reliably identify subjects from the 4 different groups: healthy, MP without trigger points, MP with latent trigger points, and MP with active trigger points?
- Will the deep learning-based marker accurately classify/predict the severity of MP in subjects with cLBP?
Read more
Participants in the healthy group will be asked to do the following tasks:
- Consent/Enrollment
- Measure Height/Weight
- Complete Questionnaires on REDCap
- Participate in Ultrasound Imaging Experiment Sessions
Participants in the chronic low back pain group will be asked to do the following tasks:
- Consent/Enrollment
- Complete Questionnaires on REDCap
- Measure Height/Weight
- Undergo a Standardized Clinical Exam
- Participate in Ultrasound Imaging Experiment Sessions
Read the detailed description
The investigators propose to use multimodal ultrasound imaging to develop and validate a practical and inexpensive biomarker for lumbar myofascial pain, which shows sensitivity to change in relation to treatment. Myofascial pain (MP) is a frequent contributing factor to chronic low back pain (cLBP). It is associated with a range of tissue abnormalities, such as taught muscle bands, trigger points (TPs), and thoracolumbar fascia motion dysfunction, along with poor tissue elasticity. As a result, a composite biomarker for MP related to components of the syndrome is more likely to be plausible biologically, robust, and useful clinically for diagnosis and treatment. The investigators propose to study: 1. The echogenicity of latent and active trigger points, 2. The dynamic spatial-temporal tissue deformation quantified by strain tensors (compression, extension, and shear) in the thoracolumbar fascia and multifidus muscle, 3. The viscoelastic properties of the fascia and muscles measured by ultrasound shear wave elastography. In the R61 Phase (year 1 to 3) the investigators will use deep learning to integrate these measurements into a predictive biomarker and use established validation methods to test its ability to predict MP.
The investigators will determine the sensitivity and specificity of the biomarker to classify the myofascial components of pain, as well as the response to treatment (a diagnostic and predictive marker).
- Conditions
- Chronic Low-back Pain, Myofascial Pain
- Being tested
- There is no intervention. It is a phenotyping study only
- Keywords
- Ultrasound, Trigger Points, Lumbar Myofascial Pain, Thoracolumbar Fascia, Multifidus Muscle, Neural Understanding Network
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention. It is a phenotyping study onlyOther
See above, this is only a phenotyping study but NIH required us to register it as a trial.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Normals | Participants with no chronic pain over a three-year timeframe. Receives: Other: There is no intervention. It is a phenotyping study only | |
| MP without TPs | Participants with chronic low back pain who are classified as having myofascial pain and no trigger points. Receives: Other: There is no intervention. It is a phenotyping study only | |
| MP with latent TPs | Participants with chronic low back pain who are classified as having myofascial pain and latent trigger points. Receives: Other: There is no intervention. It is a phenotyping study only | |
| MP with active TPs | Participants with chronic low back pain who are classified as having myofascial pain and active trigger points. Receives: Other: There is no intervention. It is a phenotyping study only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of one of 3 MP-related categories
Participants to be diagnosed as normal, MP with trigger points, or MP with tender points only, as determined by standardized clinical examinations.
Measured: Study Visit 1 (week 1)
Secondary outcomes (1)
Presence of Substantial MP
The presence of substantial MP (e.g., # active TPs and pressure pain threshold below 6.5 N/cm2) as determined by the standardized clinical examinations.
Measured: Study Visit 1 (week 1) - Study Visit 2 (week 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Oct 2023
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Ajay Wasan, MD, Msc, University of Pittsburgh
- Investigators
- Kang Kim, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928884
- Sponsor's protocol ID
- STUDY22090014
- Other IDs
- 1R61AT012282-01
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depends on the specific request from an outside party
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
- Development and Validation of a Noninvasive Multimodal Ultrasound-Based Imaging Biomarker for Myofascial Pain
- ClinicalTrials.gov ID
- NCT05928884
- Acronym / sponsor ID
- STUDY22090014
- Conditions
- Chronic Low-back Pain, Myofascial Pain
- Keywords
- Ultrasound, Trigger Points, Lumbar Myofascial Pain, Thoracolumbar Fascia, Multifidus Muscle, Neural Understanding Network
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 3 Jul 2023 (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 observational study is to develop and validate a biomarker for lumbar myofascial pain (MP) based on ultrasound obtained measurements of the lumbar muscles and fascia. The investigators will use advanced machine learning approaches and validation in a randomized controlled trial. The main questions it aims to answer are:
- Will the deep learning-based marker reliably identify subjects from the 4 different groups: healthy, MP without trigger points, MP with latent trigger points, and MP with active trigger points?
- Will the deep learning-based marker accurately classify/predict the severity of MP in subjects with cLBP?
Participants in the healthy group will be asked to do the following tasks:
- Consent/Enrollment
- Measure Height/Weight
- Complete Questionnaires on REDCap
- Participate in Ultrasound Imaging Experiment Sessions
Participants in the chronic low back pain group will be asked to do the following tasks:
- Consent/Enrollment
- Complete Questionnaires on REDCap
- Measure Height/Weight
- Undergo a Standardized Clinical Exam
- Participate in Ultrasound Imaging Experiment Sessions
Detailed description
The investigators propose to use multimodal ultrasound imaging to develop and validate a practical and inexpensive biomarker for lumbar myofascial pain, which shows sensitivity to change in relation to treatment. Myofascial pain (MP) is a frequent contributing factor to chronic low back pain (cLBP). It is associated with a range of tissue abnormalities, such as taught muscle bands, trigger points (TPs), and thoracolumbar fascia motion dysfunction, along with poor tissue elasticity. As a result, a composite biomarker for MP related to components of the syndrome is more likely to be plausible biologically, robust, and useful clinically for diagnosis and treatment. The investigators propose to study: 1. The echogenicity of latent and active trigger points, 2. The dynamic spatial-temporal tissue deformation quantified by strain tensors (compression, extension, and shear) in the thoracolumbar fascia and multifidus muscle, 3. The viscoelastic properties of the fascia and muscles measured by ultrasound shear wave elastography. In the R61 Phase (year 1 to 3) the investigators will use deep learning to integrate these measurements into a predictive biomarker and use established validation methods to test its ability to predict MP.
The investigators will determine the sensitivity and specificity of the biomarker to classify the myofascial components of pain, as well as the response to treatment (a diagnostic and predictive marker).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Normals | – | Other: There is no intervention. It is a phenotyping study onlyParticipants with no chronic pain over a three-year timeframe. |
| MP without TPs | – | Other: There is no intervention. It is a phenotyping study onlyParticipants with chronic low back pain who are classified as having myofascial pain and no trigger points. |
| MP with latent TPs | – | Other: There is no intervention. It is a phenotyping study onlyParticipants with chronic low back pain who are classified as having myofascial pain and latent trigger points. |
| MP with active TPs | – | Other: There is no intervention. It is a phenotyping study onlyParticipants with chronic low back pain who are classified as having myofascial pain and active trigger points. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators are including healthy normal and cLBP subjects from ages 20 to 70.
Key inclusion criteria (10 listed)
- No history of chronic low back pain, myofascial pain of the neck or shoulders, or fibromyalgia.
- Ages 20-70 to be age appropriate to the cLBP subjects. The investigators will recruit 10 subjects per age decile (10 subjects ages 30-39 yrs., etc.).
- Any clinically unstable systemic illness that is judged to interfere
- with the trial
- Non-ambulatory status
Key exclusion criteria (6 listed)
- Back surgery within the past year
- Active worker's compensation or litigation claims since these patients are more likely to have exaggerated pain behavior
- New pain treatments within 2 weeks of enrollment
- Any clinically unstable systemic illness that is judged to interfere with the trial
- Non-ambulatory status
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 |
|---|---|---|
| There is no intervention. It is a phenotyping study onlySee above, this is only a phenotyping study but NIH required us to register it as a trial. | Other | Healthy Normals, MP with active TPs, MP with latent TPs, MP without TPs |
Primary outcome
Diagnosis of one of 3 MP-related categories
Time frame: Study Visit 1 (week 1)
Participants to be diagnosed as normal, MP with trigger points, or MP with tender points only, as determined by standardized clinical examinations.
1 secondary outcome
Presence of Substantial MP
Time frame: Study Visit 1 (week 1) - Study Visit 2 (week 2)
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.
- Individual participant dataSharing planned: Undecided. Depends on the specific request from an outside party
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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.
Kang Kim, PhD principal investigator
University of Pittsburgh
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 Chronic Low-back Pain and Myofascial Pain, run by University of Pittsburgh 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 10 inclusion and 6 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?
Diagnosis of one of 3 MP-related categories (time frame: Study Visit 1 (week 1)). 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.