Multi-modal Imaging of Myofascial Pain - Phase 2

NCT07322445 | Recruiting DMC

• 2 other identifiers: 202506118R33AT012283
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Chemical Injection

ACTIVE COMPARATOR

Local chemical injection at clinician-identified myofascial trigger points.

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.

Procedure: Dry Needling

Interventions

Dry Needling PROCEDURE

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

Dry Needle

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

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

Chemical Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Interventions

Injections; Bupivacaine; Dry Needling

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Complementary Therapies; Physical Therapy Modalities

Central Study Contacts

Andre Guthrie, BS

CONTACT

3142732556; guthriea@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: January 7, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)