NCT07322445

Multi-modal Imaging of Myofascial Pain - Phase 2

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	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
PROCEDURE	Dry Needling	Single session of dry needling to the identified trigger point(s) per protocol.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-08-01
• Completion: 2027-12-01
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States