Multi-modal Imaging of Myofascial Pain - Phase 2

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.

Study Overview

• Status: Recruiting
• Conditions: Myofascial Pain
• Intervention / Treatment: Drug: 50/50 Mixture of Lidocaine 1% injection + Bupivacaine 0.25% Injectable Solution; Procedure: Dry Needling

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andre Guthrie, BS; Phone Number: 3142732556; Email: guthriea@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University
      • Principal Investigator: Yong Wang, PhD
      • Principal Investigator: Song Hu, PhD
      • Contact: Andre Guthrie, BS; Phone Number: 3142732556; Email: guthriea@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chemical Injection; Local chemical injection at clinician-identified myofascial trigger points.	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
Placebo Comparator: Dry Needle; Dry needling at clinician-identified myofascial trigger points.	Procedure: Dry Needling; Single session of dry needling to the identified trigger point(s) per protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and follow-up study visits approximately 2 weeks apart (each visit lasting 3-4 hours)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 6, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Surface Electromyography; Fiber-optic Imaging and Sensing
• Additional Relevant MeSH Terms: Organic Chemicals; Therapeutics; Drug Administration Routes; Drug Therapy; Complementary Therapies; Physical Therapy Modalities; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine; Injections; Dry Needling
• Other Study ID Numbers: 202506118; R33AT012283 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No