Multi-modal imaging to track myofascial neck and shoulder pain

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

This project tests whether MRI, surface EMG, and fiber‑optic imaging can track treatment response in adults with chronic myofascial neck or shoulder pain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Washington University School of Medicine (Academic / other)
• Drugs / interventions: Radiation
• Locations: 1 site (St Louis, Missouri)
• Trial ID: NCT07322445 on ClinicalTrials.gov

What this trial studies

This Phase 2 randomized study builds on Phase 1 findings that identified candidate imaging biomarkers for myofascial pain. Eligible adults with chronic neck or shoulder pain and palpable active trigger points will undergo MRI, surface electromyography (sEMG), and fiber‑optic imaging before and after treatment. Participants are randomized to receive either a local chemical injection (lidocaine/bupivacaine mix) or dry needling at the identified trigger point, with two visits about two weeks apart and patient‑reported outcome questionnaires collected. Imaging and clinical data will be analyzed to see if the biomarkers detect treatment‑related changes and predict longer‑term clinical responses.

Who should consider this trial

Good fit: Adults 18–80 with at least three months of spontaneous neck or shoulder pain, a palpable active upper‑trapezius trigger point, and average pain ≥4/10 are ideal candidates.

Not a fit: Patients with acute cervical spine injury or radiculopathy, prior head/neck/shoulder surgery, neuromuscular or inflammatory muscle diseases, or other systemic conditions are unlikely to benefit from these specific imaging biomarker results.

Why it matters

Potential benefit: If successful, these biomarkers could give clinicians objective tools to measure and predict responses to trigger‑point treatments, helping tailor care.

How similar studies have performed: Phase 1 work identified candidate biomarkers, but using multimodal imaging to monitor treatment response and predict outcomes remains relatively novel and not yet widely validated.

Eligibility criteria

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.

Where this trial is running

St Louis, Missouri

• Washington University — St Louis, Missouri, United States (Recruiting)

Study contacts

• Study coordinator: Andre Guthrie, BS

Conditions Myofascial Pain; Magnetic Resonance Imaging; Surface Electromyography; Fiber-optic Imaging and Sensing