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RecruitingNot ApplicableNCT07322445

Multi-modal Imaging of Myofascial Pain - Phase 2

Development and Identification of Magnetic Resonance, Electrophysiological, and Fiber-optic Imaging Biomarkers of Myofascial Pain

Sponsor

Washington University School of Medicine

Enrollment

100 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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.

Exclusion Criteria12

  • 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
  • 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.

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Interventions

DRUG50/50 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

PROCEDUREDry Needling

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

Locations(1)

Washington University

St Louis, Missouri, United States

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NCT07322445