- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06514638
Computational Mathematical Analysis in Vastus Medialis Between a MTrP and Non Painful Point
July 17, 2024 updated by: Samuel Fernández Carnero
Computational Mathematical Analysis of the Texture of Muscle Tissue in Vastus Medialis Between a MTrP and a Non-painful Point
With the help of ultrasound, the goal of the study is to asses the differences between MTR points and non painful points, in order to characterize the identification of MTR througought ultrasound.
Being a complex process that needs to be standarized for each muscle, the study takes place in the vastus medialis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Nowadays, myofascial trigger points (MTrP) represent one of the most common musculoskeletal alterations in clinic, being many times diffuse and complex to diagnose and localize.
Ultrasound is a therapeutic tool used in physiotherapy for assessment and treatment.
Some of its advantages include the quickness and harmlessness.
Linking these two concepts, there is no vast evidence regarding the identification of myofascial trigger points through ultrasound.
A computational mathematical analysis was performed throughout ultrasound images of the vastus medialis in order to characterize MTrPs, where images of 66 participants vastus medialis were taken.
Two investigators made the finger point palpation locating a MTrP and a non-painful point.
A third investigator screened the photographs with the ultrasound and a preset for the zone.
3 images were taken from the MTrP, 3 from the non-painful point, and other 3 of a different MTrP, in case the investigators disagreement of the MTrP location.
A fourth investigator carried out the histogram analysis using Fiji software.
Lastly, stastistical analysis of the study variables was performed.
Study Type
Observational
Enrollment (Actual)
66
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Madrid
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Alcalá De Henares, Madrid, Spain, 28871
- Nursing and Physiotherapy Faculty Study Officials
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Students in the university were the main collection of subjects because of the proximity, but also other people recruited around the city.
Description
Inclusion Criteria:
- 18-65 year old.
- Presence of pain on palpation along the course of the muscle fibers of the vastus medialis of the quadriceps.
- Painful point and/or localized tense band with or without radiation of pain to the knee area or adductor region.
Exclusion Criteria:
- Serious diseases (neurological, psychiatric, systemic diseases, obesity).
- Knee or hip surgeries.
- Muscle tears in a state of recovery in the vastus medialis of the quadriceps.
- Inability to position yourself in a lateral decubitus position.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study subjects
Helathy, 18-65 year old subjects with pain when fingerr pointed in the vastus medialis, without serious diseases.
|
Images of the vastus medialis were taken with the subject being lateral decubitus.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Echogenicity
Time Frame: Through study completion, an average of 3 months
|
Information measures of correlation at 0º, 45º, 90º, 135º expressed as mean+-standard deviation
|
Through study completion, an average of 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carlos Tercero Mendoza, BSc, University of Alcalá
- Principal Investigator: David Hernández Sánchez, BSc, University of Alcalá
- Principal Investigator: Daniel Roldán Peña, BSc, University of Alcalá
- Principal Investigator: Noe López Castellanos, BSc, University of Alcalá
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sikdar S, Shah JP, Gebreab T, Yen RH, Gilliams E, Danoff J, Gerber LH. Novel applications of ultrasound technology to visualize and characterize myofascial trigger points and surrounding soft tissue. Arch Phys Med Rehabil. 2009 Nov;90(11):1829-38. doi: 10.1016/j.apmr.2009.04.015.
- Rathbone ATL, Grosman-Rimon L, Kumbhare DA. Interrater Agreement of Manual Palpation for Identification of Myofascial Trigger Points: A Systematic Review and Meta-Analysis. Clin J Pain. 2017 Aug;33(8):715-729. doi: 10.1097/AJP.0000000000000459.
- Nadeau MJ, Desrochers A, Lamontagne M, Lariviere C, Gagnon DH. Quantitative ultrasound imaging of Achilles tendon integrity in symptomatic and asymptomatic individuals: reliability and minimal detectable change. J Foot Ankle Res. 2016 Aug 17;9:30. doi: 10.1186/s13047-016-0164-3. eCollection 2016.
- Martinez-Paya JJ, Rios-Diaz J, Del Bano-Aledo ME, Tembl-Ferrairo JI, Vazquez-Costa JF, Medina-Mirapeix F. Quantitative Muscle Ultrasonography Using Textural Analysis in Amyotrophic Lateral Sclerosis. Ultrason Imaging. 2017 Nov;39(6):357-368. doi: 10.1177/0161734617711370. Epub 2017 May 28.
- Stock MS, Thompson BJ. Echo intensity as an indicator of skeletal muscle quality: applications, methodology, and future directions. Eur J Appl Physiol. 2021 Feb;121(2):369-380. doi: 10.1007/s00421-020-04556-6. Epub 2020 Nov 21.
- Hsieh CY, Hong CZ, Adams AH, Platt KJ, Danielson CD, Hoehler FK, Tobis JS. Interexaminer reliability of the palpation of trigger points in the trunk and lower limb muscles. Arch Phys Med Rehabil. 2000 Mar;81(3):258-64. doi: 10.1016/s0003-9993(00)90068-6.
- Kumbhare DA, Elzibak AH, Noseworthy MD. Assessment of Myofascial Trigger Points Using Ultrasound. Am J Phys Med Rehabil. 2016 Jan;95(1):72-80. doi: 10.1097/PHM.0000000000000376.
- Schindelin J, Arganda-Carreras I, Frise E, Kaynig V, Longair M, Pietzsch T, Preibisch S, Rueden C, Saalfeld S, Schmid B, Tinevez JY, White DJ, Hartenstein V, Eliceiri K, Tomancak P, Cardona A. Fiji: an open-source platform for biological-image analysis. Nat Methods. 2012 Jun 28;9(7):676-82. doi: 10.1038/nmeth.2019.
Helpful Links
- 1. Borg-Stein, J., & Iaccarino, M. A. (2014). Myofascial pain syndrome treatments. Physical medicine and rehabilitation clinics of North America
- 7. Ng, G. Y., & Wong, P. Y. (2009). Patellar taping affects vastus medialis obliquus activation in subjects with patellofemoral pain before and after quadriceps muscle fatigue. Clinical rehabilitation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 13, 2023
Primary Completion (Actual)
April 25, 2024
Study Completion (Actual)
June 23, 2024
Study Registration Dates
First Submitted
July 11, 2024
First Submitted That Met QC Criteria
July 17, 2024
First Posted (Actual)
July 23, 2024
Study Record Updates
Last Update Posted (Actual)
July 23, 2024
Last Update Submitted That Met QC Criteria
July 17, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vastus ultrasound MTRp
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Yet to be decided, maybe collected as a part of a protocol to standarize.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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