Ultrasound Assessment of Myofascial Trigger Points

NCT06625905 | Completed

• 2 other identifiers: PI24/215RAT 2024-131
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Musculoskeletal pain represents a significant burden on individuals and the healthcare system in Spain, where 20% of adults experience pain, and 7% suffer from it daily. Myofascial pain syndrome (MPS), one of the most frequent causes of musculoskeletal pain, affects over 85% of the general population at some point. MPS is characterized by local or referred pain and the presence of myofascial trigger points (MTrPs). Despite advancements in diagnostic technologies, the evaluation of MTrPs still largely relies on manual palpation due to the absence of conclusive findings for their objective identification. Ultrasound presents a promising alternative as a widely available, cost-effective, and non-invasive diagnostic tool for MTrPs. While prior studies on ultrasound for MTrP detection have shown variable sensitivity and specificity (ranging from 33% to 100%), no consensus has been reached on a standardized ultrasound methodology for reliable clinical use. The ability to accurately identify MTrPs through ultrasound could shift the current paradigm, facilitating earlier diagnosis and preventing the chronicity of musculoskeletal pain, thus improving patient care and reducing healthcare costs. This study aims to evaluate ultrasound as a potential gold standard for MTrP diagnosis and characterization. By exploring optimal ultrasound modes (B-mode, Doppler), we aim to standardize a highly reliable inter-examiner diagnostic protocol that can be easily applied in clinical practice using accessible technology, such as portable wireless ultrasound devices. Specific objectives include: 1) developing ultrasound exploration protocols for MTrP detection; 2) evaluating vibration parameters for enhanced MTrP visualization; 3) characterizing MTrPs through ultrasound by analyzing size, shape, location, and echotextural features; and 4) validating proposed protocols by correlating them with manual palpation and clinical measures. This research will contribute significantly to understanding MTrPs, providing innovative diagnostic tools and protocols that will improve the precision and effectiveness of musculoskeletal pain assessment. The findings may also have important clinical implications for MTrP-related conditions, enhancing patient care and quality of life.

Conditions

Myofascial Pain; Myofascial Trigger Points; Musculoskeletal Pain

Keywords

Ultrasonography; Myofascial trigger point; Image analysis; Manual palpation

Outcome Measures

Primary Outcomes (1)

• Echovariation

  Echovariation is the primary variable of interest in this study. It refers to the variability of pixel intensities within an ultrasound image and is calculated as the ratio of the standard deviation to the mean echogenicity (brightness) of the image. This metric allows for an assessment of the texture and homogeneity of the tissue, providing insight into potential abnormalities such as the presence of myofascial trigger points (MTrPs). Echovariation is a key indicator of muscle tissue´s structural integrity and is critical in differentiating between healthy and pathological regions. The evaluation of echovariation will be conducted on ultrasound images captured from gastrocnemius medialis muscle in both longitudinal and transverse planes.

  At a single 1 day time point

Secondary Outcomes (6)

• Muscle thickness

  At a single 1 day time point

• Mean echogenicity

  At a single 1 day time point

• Myofascial trigger point area

  At a single 1 day time point

• Grey Level Run-Length Matrices (GLRLM)

  At a single 1 day time point

• Pressure Pain Threshold (PPT)

  At a single 1 day time point

Study Arms (2)

Myofascial/musculoskeletal pain group (active myofascial trigger points)

This group comprises individuals who present with myofascial and/or musculoskeletal pain, with the presence of at least one myofascial trigger point (MTrP) classified as active. Active MTrPs are characterized by the following criteria: a palpable taut band within the muscle, a hypersensitive spot within the band, and the reproduction of the patient's pain upon palpation. The selection of participants for this group will focus on individuals exhibiting active MTrPs in gastrocnemius medialis muscle.

Diagnostic Test: Ultrasound imaging

Control group (participants without pain, latent or no myofascial trigger points)

The control group consists of individuals who do not present with any musculoskeletal pain or dysfunction. These participants may or may not exhibit latent MTrPs. Latent MTrPs are defined as palpable taut bands and hypersensitive spots within the muscle that do not reproduce the patient's pain but may cause discomfort when palpated. Participants in this group will be recruited based on their lack of musculoskeletal complaints.

Diagnostic Test: Ultrasound imaging

Interventions

Ultrasound imaging DIAGNOSTIC_TEST

Both groups of participants-those with myofascial and/or musculoskeletal pain and those without musculoskeletal alterations-will undergo a standardized intervention focused on the application of vibratory stimuli, alongside real-time ultrasound imaging. Vibratory stimuli will be applied directly to the region of interest, specifically over the identified MTrP in participants with active myofascial pain. In participants without musculoskeletal alterations, the stimuli will be applied either over a latent MTrP or in a randomly selected area of the gastrocnemius medialis muscle, ensuring a consistent methodology across both groups. Simultaneously, real-time ultrasound imaging will be performed to capture detailed images of the muscle tissue during the application of vibratory stimuli. Imaging will be conducted in two planes (longitudinally and transversely).

Control group (participants without pain, latent or no myofascial trigger points); Myofascial/musculoskeletal pain group (active myofascial trigger points)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population from which the study groups or cohorts will be selected consists of individuals recruited through a variety of outreach channels coordinated by the research team. Recruitment efforts will include the dissemination of informational leaflets via multiple communication platforms, such as the official Instagram account of the iHealthy research group (@ihealthyeu) and the newsletter of the University of Zaragoza. Additionally, potential participants will be invited through direct communication with clients of the Valdespartera Physiotherapy Clinic (Zaragoza, Spain). The recruitment process will also involve collaboration with healthcare professionals, including physiotherapists and physicians, from several key institutions, such as the Lozano Blesa University Clinical Hospital, Miguel Servet Hospital, and the Seminario Health Center (Zaragoza, Spain). These professionals will be encouraged to inform their patients about the study and invite them to participate.

You may qualify if:

• For participants with myofascial/musculoskeletal pain, there must be at least one active myofascial trigger point (MTrP) in the gastrocnemius medialis muscle.
• Participants without pain may or may not have latent MTrPs in the gastrocnemius medialis muscle.

You may not qualify if:

• Any systemic medical condition, progressive neurological disease, active rheumatic disease, severe cardiac condition, malignant neoplasm, infection or acute vascular problems, fibromyalgia, myopathy, radiculopathy, myelopathy or other neuromuscular diseases.
• History of severe trauma or surgery in the last 6 months.
• Use of pacemakers or electronic implants.
• Pregnancy status.
• Obvious cognitive impairment and difficulties in communication, comprehension or cooperation.
• Physiotherapeutic treatment of a MTrP of the gastrocnemius medialis muscle with an Invasive Physiotherapy procedure (dry needling or percutaneous electrolysis) in the last month.
• Delayed onset muscle pain ("stiffness") after very intense exertion.
• Current use of any therapy (especially pharmacological) and/or any other substance that may affect the autonomic nervous system.
• Commonly accepted contraindications for Invasive Physiotherapy procedures (unbearable fear of needles, epilepsy or convulsions, etc.).

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (2)

Centro de Salud Romareda-Seminario

Zaragoza, Aragon, 50009, Spain

Location

Faculty of Health Sciences of the University of Zaragoza

Zaragoza, Aragon, 50009, Spain

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Pablo Herrero Gallego

  Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

• Eva María Gómez Trullén

  Universidad de Zaragoza

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Predoctoral Researcher and Collaborating Professor

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 3, 2024
• Study Start: December 2, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: Once research has been published

Locations

ES (2)