Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625905
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Ultrasound Assessment of Myofascial Trigger Points
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Musculoskeletal Ultrasound to Assess Myofascial Trigger Points Developing a Comprehensive Methodological Framework
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 regardless of muscle type or depth By exploring optimal ultrasound modes B-mode Doppler and settings gain frequency focus 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 identifying optimal ultrasound settings for MTrP detection 2 evaluating vibration parameters for enhanced MTrP visualization 3 developing ultrasound exploration protocols for different muscle types and depths 4 characterizing MTrPs through ultrasound by analyzing size shape location and echotextural features and 6 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
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 regardless of muscle type or depth By exploring optimal ultrasound modes B-mode Doppler and settings gain frequency focus 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 identifying optimal ultrasound settings for MTrP detection 2 evaluating vibration parameters for enhanced MTrP visualization 3 developing ultrasound exploration protocols for different muscle types and depths 4 characterizing MTrPs through ultrasound by analyzing size shape location and echotextural features and 6 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 parameters for their real-time visualization Participants will be subjected to vibratory stimuli at different frequencies and intensities applied to the MTrP location The study also aims to determine the most effective ultrasound parameters including mode gain depth and frequency and the optimal probe positioning in either transverse or longitudinal axes over the muscle
As a secondary objective the study will explore variations in ultrasound images of muscles without MTrPs comparing measurements taken from different muscles within the same individual and across other subjects The goal is to establish a reference point for defining the normal range of various muscular 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 myofascialmusculoskeletal pain with at least one active MTrP Ultrasound images of the same MTrP will be compared under different parameter settings and the resulting differences and similarities will be analyzed to identify the parameters that offer the best visualization and characterization of MTrPs Muscles of varying depths and characteristics will be examined including the infraspinatus upper trapezius medial gastrocnemius extensor digitorum communis gluteus medius paravertebral muscles longissimus iliocostalis lumbar multifidus quadriceps rectus femoris vastus intermedius vastus lateralis vastus medialis and hamstrings biceps femoris semimembranosus semitendinosus These muscles were selected based on their prevalence of MTrPs and their accessibility for palpation and ultrasound imaging The study aims to establish a standardized diagnostic protocol for identifying MTrPs in clinical practice Furthermore the potential inclusion of additional muscles will be evaluated based on their suitability for assessment
To identify MTrPs in selected muscles 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 patients 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 the following analyses leveraging the recruited sample
Diagnostic Reliability and Validation of MTrP Exploration Protocol in Superficial Muscles This section 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 selected superficial muscles 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
Diagnostic Reliability and Validation of MTrP Evaluation Protocol in Deep Muscles This section seeks to establish diagnostic reliability and validation of the MTrP evaluation protocol for deep muscles Manual palpation has proven to be imprecise and ineffective for diagnosing MTrPs in deep muscles highlighting the need for an alternative validation process The proposed method involves using dry needling to elicit a local twitch response LTR as a confirmatory criterion for MTrPs validated by its visualization on ultrasound This novel validation method promises to enhance the precision and reliability of MTrP assessment in deep muscular tissues offering a valuable diagnostic tool for healthcare professionals
As a secondary objective the study will explore variations in ultrasound images of muscles without MTrPs comparing measurements taken from different muscles within the same individual and across other subjects The goal is to establish a reference point for defining the normal range of various muscular 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 myofascialmusculoskeletal pain with at least one active MTrP Ultrasound images of the same MTrP will be compared under different parameter settings and the resulting differences and similarities will be analyzed to identify the parameters that offer the best visualization and characterization of MTrPs Muscles of varying depths and characteristics will be examined including the infraspinatus upper trapezius medial gastrocnemius extensor digitorum communis gluteus medius paravertebral muscles longissimus iliocostalis lumbar multifidus quadriceps rectus femoris vastus intermedius vastus lateralis vastus medialis and hamstrings biceps femoris semimembranosus semitendinosus These muscles were selected based on their prevalence of MTrPs and their accessibility for palpation and ultrasound imaging The study aims to establish a standardized diagnostic protocol for identifying MTrPs in clinical practice Furthermore the potential inclusion of additional muscles will be evaluated based on their suitability for assessment
To identify MTrPs in selected muscles 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 patients 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 the following analyses leveraging the recruited sample
Diagnostic Reliability and Validation of MTrP Exploration Protocol in Superficial Muscles This section 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 selected superficial muscles 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
Diagnostic Reliability and Validation of MTrP Evaluation Protocol in Deep Muscles This section seeks to establish diagnostic reliability and validation of the MTrP evaluation protocol for deep muscles Manual palpation has proven to be imprecise and ineffective for diagnosing MTrPs in deep muscles highlighting the need for an alternative validation process The proposed method involves using dry needling to elicit a local twitch response LTR as a confirmatory criterion for MTrPs validated by its visualization on ultrasound This novel validation method promises to enhance the precision and reliability of MTrP assessment in deep muscular tissues offering a valuable diagnostic tool for healthcare professionals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None