Recruiting

Imaging Biomarkers

Sponsor:

Washington University School of Medicine

Code:

NCT07322445

Conditions

Myofascial Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

50/50 Mixture of Lidocaine 1% injection + Bupivacaine 0.25% Injectable Solution

Dry Needling

Study Details

Brief 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.

Conditions

Myofascial Pain

Study ID

NCT07322445

Start date

Oct 24, 2023

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adults between the ages of 18 and 80 years old.
2. 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.
3. Presence of a palpable myofascial trigger point (MTrP) in one or both upper trapezius muscles.
4. 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.
5. Pain localized to the area of the trigger point that is reproduced or worsened upon palpation.
6. Radiation of pain to the head, neck, or face with palpation is allowed but not required.

Exclusion Criteria:

1. Age <18 or >80 years old.
2. Acute cervical spine pathology, trauma (e.g. whiplash) or cervical radiculopathy
3. History of surgery involving the head, neck, or shoulder girdle.
4. Presence of neuromuscular pathologies or inflammatory muscle diseases (e.g. dermatomyositis)
5. Systemic disease with diffuse body pain (e.g. system lupus erythematosus)
6. Peripheral neuropathy
7. Cancer-related pain
8. 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.
9. Contraindication to MRI
10. Chronic fatigue syndrome, fibromyalgia, or chronic Lyme disease.
11. Use of acupuncture or changes in pain medications within 6 weeks of enrollment.
12. Receipt of Botox injection to the neck/shoulder region within the past 3 months or trigger point injection within the past 6 weeks.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Chemical Injection

Local chemical injection at clinician-identified myofascial trigger points.

placebo comparator: Dry Needle

Dry needling at clinician-identified myofascial trigger points.

Interventions

50/50 Mixture of Lidocaine 1% injection + Bupivacaine 0.25% Injectable Solution

Treatment Group: Receives trigger-point injection with a 50/50 mixture of 1% lidocaine and 0.25% bupivacaine

Dry Needling

Single session of dry needling to the identified trigger point(s) per protocol.

Primary outcome measure

  • Statistical Plan [ Time Frame: Baseline and follow-up study visits approximately 2 weeks apart (each visit lasting 3-4 hours) ]

Central Contacts and Locations

Central contacts

Locations

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Yong Wang, PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Keywords

  • Magnetic Resonance Imaging
  • Surface Electromyography
  • Fiber-optic Imaging and Sensing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-09-03.