Evaluation of a Novel Class of Objective Myofascial Pain Assessments

Trigger Point Pain, Myofascial Clinical Trial

— ENCOMPASS  

Official title:

Electrophysiological and Ultrasound Quantitative Biomarkers for Myofascial Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05793086
• Other study ID #: 2022P000543
• Status: Recruiting
• Start date: January 27, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: April 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Ajitesh Nanda
• Phone: 617-667-3083
• Email: ananda2[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Study Visit One:

1. Overview

2. History and examination (All participants). After reviewing the purpose and procedures of the study, the subject, or a legally authorized representative (LAR), will be asked to sign the internal review board-approved informed consent form.

Basic medical, social, and family histories will then be obtained and recorded. Previous medical records will be reviewed. Medications, including drug doses, history of recent medication changes, and duration of treatment) will be reviewed.

A brief physical exam will be performed. If the subject has MPS, the study doctor will identify the trigger points and will mark those with a permanent marker.

3. Electrical Impedance Myography (EIM) - a trained technician will apply several small sticky pads (electrodes) to different parts of the subject's muscle and a very tiny electrical current will be applied that they will not feel. Several measurements will be done their muscle. This will take approximately 10 minutes

4. Ultrasound (US) - a trained technician will apply a small amount of gel to the skin. They will hold a small hand-held device on the skin and will measure the muscle. The gel is easily cleaned off of the skin when the testing is complete. This will take approximately 20 minutes

5. Threshold Tracking (TT) - TT tests how quickly muscle responds to stimulation. The muscle is stimulated using a small needle which is placed superficially in their trapezius muscle. The subject will feel a small needle prick which should be less uncomfortable than having blood drawn. Electrodes (small sticky pads) are placed a short distance from the needle over the muscle. When their muscle is stimulated with the needle, the time it takes for the muscle to react is measured by the electrodes. This procedure will last 30 minutes and creates a tingling feeling.

6. Questionnaires- Subjects will be asked to complete some brief questionnaires about their pain, mood, and sleep. Overall, this visit will take approximately 1 - 1.5 hours.

Home Period Subjects will be asked to re-inforce/re-apply the permanent marker spots made at their first visit. This is so investigators can use the same spots for testing at the next visit.

Study Visit 2 (2-14 days after Study Visit #1) The second study visit is identical to the first one. A study team member will test the subject's trigger points again at the beginning of the visit. This visit will also last approximately 1-1.5 hours.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myofascial Pain
• Myofascial Pain Syndromes
• Trigger Point Pain, Myofascial

Intervention

Diagnostic Test:
• Ultrasound
Using shear wave elastography and gray scale analysis of ultrasound.
• Electrical impedance myography
Measurement of localized bioimpedance of muscle
• Excitability testing
Electrical studies of myofiber excitability

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome: Electrical Impedance Myography (EIM)	The primary outcome will be 100 kHz phase angle in EIM	2.5 years
Secondary	Secondary outcome: Ultrasound with shear wave elastography (SWE)	echointensity and elastic modulus	2.5 years
Secondary	Secondary outcome: Excitability threshold tracking (TT)	The secondary outcome will be maximum latency change with a conditioning stimulus	2.5 years