Multi-modal Imaging of Myofascial Pain - Phase 2
ConditionMyofascial Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
50/50 Mixture of Lidocaine 1% injection + Bupivacaine 0.25% Injectable Solution
DrugTreatment Group: Receives trigger-point injection with a 50/50 mixture of 1% lidocaine and 0.25% bupivacaine
Dry Needling
Procedure/SurgerySingle session of dry needling to the identified trigger point(s) per protocol.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Chemical InjectionActive comparator 1 intervention
Group B: Dry NeedlePlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and follow-up study visits approximately 2 weeks apart (each visit lasting 3-4 hours)Sponsors and contacts
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Washington University School of Medicine
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov