Evaluation of a Novel Class of Objective Myofascial Pain Assessments (NCT05793086) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of a Novel Class of Objective Myofascial Pain Assessments
United States90 participantsStarted 2023-01-27
Plain-language summary
This is an observational study that is intended to determine the capacity of three technologies to serve as diagnostic biomarkers for myofascial pain syndrome. Investigators will seek patients with myofasical pain syndrome as well as healthy subjects for this study. Electrical impedance myography (EIM), myofiber threshold tracking (TT) excitability testing, and ultrasound with shear wave elastography (SWE) measurements will be obtained from the trapezius muscle (the muscle that extends over the back of the neck and shoulders). These measurements will be repeated within 2-5 days to assess repeatability of these methods.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Ages: 18-80
✓. Myofascial Pain Syndrome with active and/or latent TrPs, as diagnosed by a pain specialist, with involvement of the trapezius meeting criteria (detailed in "Methods"))
✓. Capacity to manage breakthrough pain medications during the study with only acetaminophen
Exclusion criteria
✕. Presence of radicular pain, superimposed neuromuscular disease, or condition
✕. Fibromyalgia or other generalized pain condition
✕. Opioid use
✕. Active mood or substance use disorder
✕. Taking or unable to wean off pain medications that directly affect neuronal or muscle excitability at least 2 weeks prior to study enrollment and remain off for the duration of the study: gabapentin, pregabalin, topiramate, carbamazepine, oxcarbazepine, valproic acid, tricyclic antidepressants (such as nortriptyline and amitriptyline), tizanidine, cyclobenzaprine, carisoprodol, methocarbamol, benzodiazepines
. Skin allergy or sensitivity that would preclude the use of adhesive electrodes
✕. Systemic or psychiatric illness that in the opinion of the Site Investigator would interfere with the individual's ability to participate in the trial.
✕. Anticoagulation (with coumadin, clopidogrel, or direct oral anticoagulants; aspirin acceptable).