Evaluation of a Novel Class of Objective Myofascial Pain Assessments

NCT05793086 | Active Not Recruiting FDA Device

• 1 other identifier: 2022P000543
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Myofascial Pain; Trigger Point Pain, Myofascial

Keywords

Myofascial Pain; Trigger point

Outcome Measures

Primary Outcomes (1)

• Primary outcome: Electrical Impedance Myography (EIM)

  The primary outcome will be 100 kHz phase angle in EIM

  2.5 years

Secondary Outcomes (2)

• Secondary outcome: Ultrasound with shear wave elastography (SWE)

  2.5 years

• Secondary outcome: Excitability threshold tracking (TT)

  2.5 years

Study Arms (3)

active trigger point group

Individuals with active trigger points in trapezius

Diagnostic Test: Ultrasound; Diagnostic Test: Electrical impedance myography; Diagnostic Test: Excitability testing

latent trigger point group

Individuals with trigger points in trapezius without spontaneous pain

Diagnostic Test: Ultrasound; Diagnostic Test: Electrical impedance myography; Diagnostic Test: Excitability testing

healthy trapezius muscle

Individuals without trigger points.

Diagnostic Test: Ultrasound; Diagnostic Test: Electrical impedance myography; Diagnostic Test: Excitability testing

Interventions

Ultrasound DIAGNOSTIC_TEST

Using shear wave elastography and gray scale analysis of ultrasound.

active trigger point group; healthy trapezius muscle; latent trigger point group

Electrical impedance myography DIAGNOSTIC_TEST

Measurement of localized bioimpedance of muscle

active trigger point group; healthy trapezius muscle; latent trigger point group

Excitability testing DIAGNOSTIC_TEST

Electrical studies of myofiber excitability

active trigger point group; healthy trapezius muscle; latent trigger point group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with myofascial pain syndrome with active and/or latent TrPs, as diagnosed by a pain specialist, with involvement of the trapezius meeting

You may qualify if:

• 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

You may not qualify if:

• 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).
• Healthy volunteers
• \. Ages: 18-80
• Presence of radicular, myofascial, or generalized pain, superimposed neuromuscular disease or condition
• History of MPS, examination demonstrating trigger points
• Fibromyalgia or other generalized pain condition
• Opioid use
• Active mood or substance use disorder

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Massachusetts General Hospital: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurology Department Chair

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: March 31, 2023
• Study Start: January 27, 2023
• Primary Completion: May 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)