Multi-modal Imaging of Myofascial Pain - Phase 2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 50/50 Mixture of Lidocaine 1% injection + Bupivacaine 0.25% Injectable Solution, Dry Needling.
- Who it may be relevant to
- Registry conditions: Myofascial Pain. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Identification of Magnetic Resonance, Electrophysiological, and Fiber-optic Imaging Biomarkers of Myofascial Pain
Overview
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.
Interventions
- 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 - Procedure Dry Needling
Single session of dry needling to the identified trigger point(s) per protocol.
Primary outcome measures
- Statistical Plan [Time frame: Baseline and follow-up study visits approximately 2 weeks apart (each visit lasting 3-4 hours)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Washington University — St Louis
Identifiers
NCT: NCT07322445 · 202506118 · R33AT012283