Ultrasound Assessment of Myofascial Trigger Points

NCT ID: NCT06625905

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2025-07-01

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.

Detailed Description

This exploratory study aims primarily to characterize myofascial trigger points (MTrPs) and identify the optimal ultrasound protocol for their real-time visualization. Participants will be subjected to vibratory stimuli applied to the MTrP location.

As a secondary objective, the study will explore variations in ultrasound imaging of muscles without MTrPs, comparing measurements taken within the same muscle between different subjects. The goal is to establish a reference point for defining the normal range of various muscle echotexture values in ultrasound images of healthy individuals. This analysis will include metrics such as mean echogenicity, coefficient of variation of echogenicity, co-occurrence, and run-length matrices, among others.

To achieve this, the study will recruit subjects without musculoskeletal disorders (with or without latent MTrPs) and those with myofascial/musculoskeletal pain (with at least one active MTrP). Ultrasound images of the gastrocnemius medialis muscle, which has been selected because of the prevalence of MTrPs and its accessibility for palpation and ultrasound, will be analyzed.

To identify MTrPs in the selected muscle, both in participants with and without pain, at least two of the following diagnostic criteria must be met: 1) a palpable taut band within the muscle; 2) the presence of a hypersensitive spot within the taut band; and 3) referred pain when the MTrP is compressed. Although we are aware of the risk of false negatives, for participants with pain, to differentiate an active MTrP from a latent one, an active MTrP must reproduce the patient's symptoms, as both active and latent MTrPs commonly exhibit a taut band and hypersensitive spot.

The analysis of the data extracted from this study aims to discern any distinguishing features that could contribute to developing a model capable of accurately identifying MTrPs. This will involve using machine learning techniques or statistical modeling.

Additionally, the study will incorporate an analysis of the diagnostic reliability and validation of MTrP exploration protocol in superficial muscles, leveraging the recruited sample. This analysis aims to validate the MTrP exploration protocol by evaluating diagnostic reliability between ultrasound and manual palpation. Manual palpation is currently the most widely accepted criterion for MTrP diagnosis. An expert physiotherapist specialized in myofascial pain will use manual palpation to diagnose MTrPs in gastrocnemius medialis muscle. Using a dermographic pen, the exact area of the MTrP, as well as a control area outside the MTrP and tight band within the same muscle, will be marked. If no MTrP is detected, a random area within the muscle of interest will be marked instead. In both cases, a cross will be drawn to ensure precision in ultrasound probe placement for both longitudinal and transverse sections. This dual evaluation approach, combining manual palpation and ultrasound, aims to provide a comprehensive and reliable assessment of MTrPs in superficial muscles. The results will further clarify the effectiveness and accuracy of the MTrP exploration protocol, offering essential insights for clinicians and researchers involved in myofascial pain diagnosis and treatment.

Conditions

Myofascial Pain; Myofascial Trigger Points; Musculoskeletal Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Ultrasound imaging

Intervention Type: 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)

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.

Ultrasound imaging

Intervention Type: 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).

Interventions

Ultrasound imaging

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Zaragoza

OTHER

Sponsor Role: lead

Responsible Party

Diego Lapuente Hernández

Predoctoral Researcher and Collaborating Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pablo Herrero Gallego

Role: PRINCIPAL_INVESTIGATOR

Universidad de Zaragoza

Eva María Gómez Trullén

Role: STUDY_DIRECTOR

Universidad de Zaragoza

Locations

Centro de Salud Romareda-Seminario

Zaragoza, Aragon, Spain

Faculty of Health Sciences of the University of Zaragoza

Zaragoza, Aragon, Spain

Countries

Spain

Other Identifiers

RAT 2024-131

Identifier Type: OTHER

Identifier Source: secondary_id

PI24/215

Identifier Type: -

Identifier Source: org_study_id