Evaluating new methods for diagnosing myofascial pain

Electrophysiological and Ultrasound Quantitative Biomarkers for Myofascial Pain

This study is testing new non-invasive methods to see if they can accurately diagnose myofascial pain syndrome in people who have it and in healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 90 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beth Israel Deaconess Medical Center (Academic / other)
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT05793086 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness of three innovative technologies—Electrical Impedance Myography (EIM), Threshold Tracking (TT) excitability testing, and ultrasound with shear wave elastography (SWE)—as diagnostic biomarkers for myofascial pain syndrome. Participants with myofascial pain syndrome and healthy subjects will undergo a series of non-invasive tests on the trapezius muscle to evaluate the repeatability and reliability of these methods. The study will involve a thorough medical history, physical examination, and multiple measurement sessions within a short timeframe.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 diagnosed with myofascial pain syndrome involving the trapezius muscle.

Not a fit: Patients with radicular pain, fibromyalgia, or those using certain pain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and objective diagnostic methods for myofascial pain syndrome, improving patient management.

How similar studies have performed: While the specific combination of these technologies is novel, similar approaches have shown promise in other studies focused on myofascial pain assessment.

Eligibility criteria

Myofascial Pain Syndrome with active and/or latent TrPs

Inclusion Criteria:

1. Ages: 18-80
2. 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"))
3. Capacity to manage breakthrough pain medications during the study with only acetaminophen

Exclusion Criteria:

1. Presence of radicular pain, superimposed neuromuscular disease, or condition
2. Fibromyalgia or other generalized pain condition
3. Opioid use
4. Active mood or substance use disorder
5. 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
6. Skin allergy or sensitivity that would preclude the use of adhesive electrodes
7. Systemic or psychiatric illness that in the opinion of the Site Investigator would interfere with the individual's ability to participate in the trial.
8. Anticoagulation (with coumadin, clopidogrel, or direct oral anticoagulants; aspirin acceptable).

Healthy volunteers

Inclusion Criteria:

1. Ages: 18-80

Exclusion Criteria:

1. Presence of radicular, myofascial, or generalized pain, superimposed neuromuscular disease or condition
2. History of MPS, examination demonstrating trigger points
3. Fibromyalgia or other generalized pain condition
4. Opioid use
5. Active mood or substance use disorder
6. 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
7. Skin allergy or sensitivity that would preclude85 the use of adhesive electrodes
8. Systemic or psychiatric illness that in the opinion of the Site Investigator would interfere with the individual's ability to participate in the trial.

Where this trial is running

Boston, Massachusetts and 1 other locations

• Massachusetts General Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Ajitesh Nanda

Conditions Myofascial Pain; Trigger Point Pain, Myofascial; Trigger point