Multi-modal Imaging of Myofascial Pain - Phase 2

NCT ID: NCT07322445

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Chemical Injection

Local chemical injection at clinician-identified myofascial trigger points.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Dry Needle

Dry needling at clinician-identified myofascial trigger points.

Group Type: PLACEBO_COMPARATOR

Dry Needling

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: DRUG

Dry Needling

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Yong Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Washington University

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Andre Guthrie, BS

Role: CONTACT

guthriea@wustl.edu

3142732556

Facility Contacts

Andre Guthrie, BS

Role: primary

guthriea@wustl.edu

3142732556

Other Identifiers

R33AT012283

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202506118

Identifier Type: -

Identifier Source: org_study_id