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NCT Number: NCT07322445

Multi-modal Imaging of Myofascial Pain - Phase 2

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Andre Guthrie, BS

CONTACT

[email protected]

3142732556

Song Hu, PhD

PRINCIPAL_INVESTIGATOR

Yong Wang, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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

dry needling

Procedure

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

Primary outcomes

  1. Statistical Plan

    Time frame: Baseline and follow-up study visits approximately 2 weeks apart (each visit lasting 3-4 hours)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andre Guthrie, BS

CONTACT

[email protected]

3142732556

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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