Imaging Biomarkers for Myofascial Pain

NCT06060925 | Completed FDA Device

• 1 other identifier: 1933416
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Myofascial pain syndrome (MPS) is highly prevalent in the community. It is primarily diagnosed using patient self reports and physical examination, which lack reliability, sensitivity and specificity and does not provide insights into the abnormal biological and physiological processes in soft tissues. While a number of treatment methods are available to patients, there are currently no criteria to determine which treatments might be best for each patient's unique myofascial pain phenotype. To improve evidence-based management of myofascial pain, there is a critical need to develop quantitative measures that advance the understanding of the physiological processes in the underlying the soft tissues across the clinical continuum of MPS. The objective of this project is to develop a quantitative biomarker informed by the current understanding of underlying tissue-level mechanisms at the level of the "myofascial unit" (muscle, nerve, fascia, vasculature, lymphatics) that are likely to be involved in MPS.

Conditions

Myofascial Pain Syndrome; Healthy

Keywords

ultrasound imaging; bioimpedance spectroscopy; electromyography; fascia; blood flow

Outcome Measures

Primary Outcomes (4)

• Ultrasound shear wave elastography

  Shear wave elastography utilizes the radiation force of ultrasound to induce shear waves in tissue and measure the propagation speed. It provides information about the mechanical properties of tissue. We will extract the shear anisotropy ratio as the outcome measure.

  Baseline, month 3

• Ultrasound Doppler

  Ultrasound Doppler estimates the flow velocity in blood vessels. We will extract end-diastolic velocity as the outcome measure.

  Baseline, month 3

• Bioimpedance spectroscopy

  Bioimpedance spectroscopy involves sending a small current into tissue at different frequencies and estimating the resistance and reactance. It can be used to measure fluid content in the extracellular space.

  Baseline, month 3

• High density electromyography

  High density electromyography involves the placement of a 64-channel electrode array on the skin surface and measuring the electrical activity of muscles. It can be used to measure motor unit excitability. We will extract the Force/EMG ratio as the outcome measure.

  Baseline, month 3

Secondary Outcomes (5)

• NIH HEAL Common data elements for adult chronic pain

  Baseline, month 3

• Windup ratio

  Baseline, month 3

• Pressure pain threshold

  Baseline, month 3

• Cervical and shoulder range of motion

  Baseline, month 3

• Ecological Momentary Assessment

  Month 1-3

Study Arms (3)

Active myofascial pain syndrome

Subjects that experience spontaneous pain

Diagnostic Test: Ultrasound imaging; Diagnostic Test: Bioimpedance spectroscopy; Diagnostic Test: Electromyography; Diagnostic Test: Physical examination

Latent myofascial pain syndrome

Subjects that elicit pain only when palpated and disturbed.

Diagnostic Test: Ultrasound imaging; Diagnostic Test: Bioimpedance spectroscopy; Diagnostic Test: Electromyography; Diagnostic Test: Physical examination

Subjects without pain

No symptoms of chronic pain.

Diagnostic Test: Ultrasound imaging; Diagnostic Test: Bioimpedance spectroscopy; Diagnostic Test: Electromyography; Diagnostic Test: Physical examination

Interventions

Ultrasound imaging DIAGNOSTIC_TEST

B-mode, color Doppler, shear wave elastography

Active myofascial pain syndrome; Latent myofascial pain syndrome; Subjects without pain

Bioimpedance spectroscopy DIAGNOSTIC_TEST

Multifrequency bioimpedance spectroscopy

Active myofascial pain syndrome; Latent myofascial pain syndrome; Subjects without pain

Electromyography DIAGNOSTIC_TEST

High density electromyography

Active myofascial pain syndrome; Latent myofascial pain syndrome; Subjects without pain

Physical examination DIAGNOSTIC_TEST

Comprehensive musculoskeletal physical examination, including range of motion, and quantitative sensory testing

Active myofascial pain syndrome; Latent myofascial pain syndrome; Subjects without pain

Eligibility Criteria

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

Study Population

Our chosen pain condition is chronic neck and shoulder pain. We will recruit two groups of subjects: Group 1: Chronic myofascial pain as determined by baseline clinical examination (using Travell and Simons criteria) and Group 2: pain free controls. We will focus on two standardized anatomical locations. This will enable imaging the medial upper trapezius and the infraspinatus muscles, which are common locations for MTrPs56as well as the levator scapulae.These three muscles have quite different morphology and fasciae46.The levator is a fusiform muscle with well-defined fascia that includes the musclewhile the trapezius has thinner fasciafrom where perimysiumseptae crossthe muscle belly.

You may qualify if:

• Age 18 and older

You may not qualify if:

• Diagnosis of fibromyalgia, chronic fatigue syndrome or chronic Lyme disease confirmed by physical exam
• Diagnosis of cervical radiculopathy, neuropathy or neuriitis
• History of head, neck, or shoulder girdle surgery
• Atypical facial neuralgia
• New medication or change in medication in past 6 months
• Current throat or ear infection

Sponsors & Collaborators

• George Mason University: lead

Study Sites (1)

George Mason University

Fairfax, Virginia, 22030, United States

Location

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MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Ultrasonography; Electromyography; Physical Examination

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Myography

Study Officials

• Siddhartha Sikdar, PhD

  George Mason University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: September 29, 2023
• Study Start: January 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)