Myofascial PainNCT07322445
Multi-modal Imaging of Myofascial Pain - Phase 2
A study testing 50/50 Mixture of Lidocaine 1% injection + Bupivacaine 0.25% Injectable Solution and Dry Needling in people with Myofascial Pain, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The goal of this study is to evaluate imaging biomarkers for quantitative assessments of myofascial pain and determine their ability to monitor treatment response and predict clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myofascial Pain
- What is being tested?
- 50/50 Mixture of Lidocaine 1% injection + Bupivacaine 0.25% Injectable Solution and Dry Needling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between the ages of 18 and 80 years old.
- History of spontaneous (non-provoked) pain in the neck and/or shoulder region lasting at least 3 months. Neck and/or shoulder pain, unilateral or bilateral.
- Presence of a palpable myofascial trigger point (MTrP) in one or both upper trapezius muscles.
- The participant has a Numeric Pain Rating Scale of 4/10 or more in the last one week, and the pain is reproducible by palpating the trigger point.
- Pain localized to the area of the trigger point that is reproduced or worsened upon palpation.
- Radiation of pain to the head, neck, or face with palpation is allowed but not required.
Who cannot join
- Age <18 or >80 years old.
- Acute cervical spine pathology, trauma (e.g. whiplash) or cervical radiculopathy
- History of surgery involving the head, neck, or shoulder girdle.
- Presence of neuromuscular pathologies or inflammatory muscle diseases (e.g. dermatomyositis)
- Systemic disease with diffuse body pain (e.g. system lupus erythematosus)
- Peripheral neuropathy
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- Cancer-related pain
- Pregnancy, coagulopathy or other bleeding disorder, fever, general/local infection at the pain site, substance abuse, or any other diseases that may account for signs and symptoms mimicking myofascial pain.
- Contraindication to MRI
- Chronic fatigue syndrome, fibromyalgia, or chronic Lyme disease.
- Use of acupuncture or changes in pain medications within 6 weeks of enrollment.
- Receipt of Botox injection to the neck/shoulder region within the past 3 months or trigger point injection within the past 6 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University
St Louis, Missouri, 63110
Andre Guthrie, BS, 3142732556, guthriea@wustl.edu
Yong Wang, PhD
About this study
Official title: Development and Identification of Magnetic Resonance, Electrophysiological, and Fiber-optic Imaging Biomarkers of Myofascial Pain
The goal of this study is to evaluate imaging biomarkers for quantitative assessments of myofascial pain and determine their ability to monitor treatment response and predict clinical outcomes.
Read the detailed description
This Phase 2 randomized clinical trial builds upon findings from Phase 1, which identified candidate imaging biomarkers of myofascial pain. The study will assess whether these biomarkers can monitor responses to local chemical injection treatment and predict clinical outcomes.
Participants with neck/shoulder pain and the presence of active myofascial trigger points will be referred from pain management clinics or recruited through the Volunteer for Health office. Eligible participants will undergo multi-modal imaging procedures, including magnetic resonance imaging (MRI), surface electromyography (sEMG), and fiber-optic imaging. Participants will then be randomized to receive either chemical injection or dry needling at the identified trigger points.
Over the course of two study visits, spaced approximately two weeks apart, participants will complete imaging procedures and patient-reported outcome questionnaires. The study team will analyze imaging and clinical data to evaluate the capacity of identified biomarkers to detect treatment-related changes and to predict longer-term clinical response.
- Conditions
- Myofascial Pain
- Being tested
- 50/50 Mixture of Lidocaine 1% injection + Bupivacaine 0.25% Injectable Solution, Dry Needling
- Keywords
- Magnetic Resonance Imaging, Surface Electromyography, Fiber-optic Imaging and Sensing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50/50 Mixture of Lidocaine 1% injection + Bupivacaine 0.25% Injectable SolutionDrug
Treatment Group: Receives trigger-point injection with a 50/50 mixture of 1% lidocaine and 0.25% bupivacaine
Dry NeedlingProcedure or surgery
Single session of dry needling to the identified trigger point(s) per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Chemical Injection | Active comparator | Local chemical injection at clinician-identified myofascial trigger points. Receives: Drug: 50/50 Mixture of Lidocaine 1% injection + Bupivacaine 0.25% Injectable Solution |
| Dry Needle | Placebo comparator | Dry needling at clinician-identified myofascial trigger points. Receives: Procedure: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistical Plan
The statistical analysis will assess the ability of imaging biomarkers to distinguish pathological and physiological differences among participant groups. Imaging biomarkers of the myofascial tissue will be measured for each participant, including tissue stiffness, hydration, inflammation, blood oxygenation and flow, and electrical activity. Group differences in each imaging biomarker will be evaluated independently using Student's t-test or Wilcoxon rank-sum test, as appropriate. Each biomarker will be analyzed and reported separately and will not be combined into a composite measure. We hypothesize that some imaging biomarkers will demonstrate large effect sizes between participant groups. Statistical power will be estimated based on Cohen's d for individual biomarkers. With an expected effect size greater than 0.9, the proposed sample size provides greater than 80% power. Multi-modal imaging is expected to identify biomarkers with strong group differences.
Measured: Baseline and follow-up study visits approximately 2 weeks apart (each visit lasting 3-4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start24 Oct 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial PainStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Yong Wang, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322445
- Sponsor's protocol ID
- 202506118
- Other IDs
- R33AT012283
- Status last verified
- Aug 2026
- First submitted
- 6 Oct 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Identification of Magnetic Resonance, Electrophysiological, and Fiber-optic Imaging Biomarkers of Myofascial Pain
- ClinicalTrials.gov ID
- NCT07322445
- Acronym / sponsor ID
- 202506118
- Conditions
- Myofascial Pain
- Keywords
- Magnetic Resonance Imaging, Surface Electromyography, Fiber-optic Imaging and Sensing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 7 Jan 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.
The goal of this study is to evaluate imaging biomarkers for quantitative assessments of myofascial pain and determine their ability to monitor treatment response and predict clinical outcomes.
Detailed description
This Phase 2 randomized clinical trial builds upon findings from Phase 1, which identified candidate imaging biomarkers of myofascial pain. The study will assess whether these biomarkers can monitor responses to local chemical injection treatment and predict clinical outcomes.
Participants with neck/shoulder pain and the presence of active myofascial trigger points will be referred from pain management clinics or recruited through the Volunteer for Health office. Eligible participants will undergo multi-modal imaging procedures, including magnetic resonance imaging (MRI), surface electromyography (sEMG), and fiber-optic imaging. Participants will then be randomized to receive either chemical injection or dry needling at the identified trigger points.
Over the course of two study visits, spaced approximately two weeks apart, participants will complete imaging procedures and patient-reported outcome questionnaires. The study team will analyze imaging and clinical data to evaluate the capacity of identified biomarkers to detect treatment-related changes and to predict longer-term clinical response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemical Injection | Active comparator | Drug: 50/50 Mixture of Lidocaine 1% injection + Bupivacaine 0.25% Injectable SolutionLocal chemical injection at clinician-identified myofascial trigger points. |
| Dry Needle | Placebo comparator | Procedure: Dry NeedlingDry needling at clinician-identified myofascial trigger points. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults between the ages of 18 and 80 years old.
- History of spontaneous (non-provoked) pain in the neck and/or shoulder region lasting at least 3 months. Neck and/or shoulder pain, unilateral or bilateral.
- Presence of a palpable myofascial trigger point (MTrP) in one or both upper trapezius muscles.
- The participant has a Numeric Pain Rating Scale of 4/10 or more in the last one week, and the pain is reproducible by palpating the trigger point.
- Pain localized to the area of the trigger point that is reproduced or worsened upon palpation.
Key exclusion criteria (12 listed)
- Age <18 or >80 years old.
- Acute cervical spine pathology, trauma (e.g. whiplash) or cervical radiculopathy
- History of surgery involving the head, neck, or shoulder girdle.
- Presence of neuromuscular pathologies or inflammatory muscle diseases (e.g. dermatomyositis)
- Systemic disease with diffuse body pain (e.g. system lupus erythematosus)
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 |
|---|---|---|
| 50/50 Mixture of Lidocaine 1% injection + Bupivacaine 0.25% Injectable SolutionTreatment Group: Receives trigger-point injection with a 50/50 mixture of 1% lidocaine and 0.25% bupivacaine | Drug | Chemical Injection |
| Dry NeedlingSingle session of dry needling to the identified trigger point(s) per protocol. | Procedure or surgery | Dry Needle |
Primary outcome
Statistical Plan
Time frame: Baseline and follow-up study visits approximately 2 weeks apart (each visit lasting 3-4 hours)
The statistical analysis will assess the ability of imaging biomarkers to distinguish pathological and physiological differences among participant groups. Imaging biomarkers of the myofascial tissue will be measured for each participant, including tissue stiffness, hydration, inflammation, blood oxygenation and flow, and electrical activity. Group differences in each imaging biomarker will be evaluated independently using Student's t-test or Wilcoxon rank-sum test, as appropriate. Each biomarker will be analyzed and reported separately and will not be combined into a composite measure. We hypothesize that some imaging biomarkers will demonstrate large effect sizes between participant groups. Statistical power will be estimated based on Cohen's d for individual biomarkers. With an expected effect size greater than 0.9, the proposed sample size provides greater than 80% power. Multi-modal imaging is expected to identify biomarkers with strong group differences.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 50/50 Mixture of Lidocaine 1% injection + Bupivacaine 0.25% Injectable Solution and Dry Needling in people with Myofascial Pain, run by Washington University School of Medicine 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 3 Sep 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andre Guthrie, BS (3142732556, guthriea@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistical Plan (time frame: Baseline and follow-up study visits approximately 2 weeks apart (each visit lasting 3-4 hours)). 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 3 Sep 2026.