NCT06514638

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 11, 2024

Last Update Submit

July 17, 2024

Conditions

Keywords

ultrasoundmyofascial trigger pointvastus medialis

Outcome Measures

Primary Outcomes (1)

  • Echogenicity

    Information measures of correlation at 0º, 45º, 90º, 135º expressed as mean+-standard deviation

    Through study completion, an average of 3 months

Study Arms (1)

Study subjects

Helathy, 18-65 year old subjects with pain when fingerr pointed in the vastus medialis, without serious diseases.

Other: Ultrasound imaging

Interventions

Images of the vastus medialis were taken with the subject being lateral decubitus.

Study subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nursing and Physiotherapy Faculty Study Officials

Alcalá de Henares, Madrid, 28871, Spain

Location

Related Publications (8)

  • 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.

    PMID: 19887205BACKGROUND
  • 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.

    PMID: 10724067BACKGROUND
  • 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.

    PMID: 28098584BACKGROUND
  • 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.

    PMID: 28553752BACKGROUND
  • 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.

    PMID: 26334421BACKGROUND
  • 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.

    PMID: 27540416BACKGROUND
  • 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.

    PMID: 33221942BACKGROUND
  • 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.

    PMID: 22743772BACKGROUND

Related Links

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Carlos Tercero Mendoza, BSc

    University of Alcala

    PRINCIPAL INVESTIGATOR
  • David Hernández Sánchez, BSc

    University of Alcala

    PRINCIPAL INVESTIGATOR
  • Daniel Roldán Peña, BSc

    University of Alcala

    PRINCIPAL INVESTIGATOR
  • Noe López Castellanos, BSc

    University of Alcala

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physical Therapy PhD

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 23, 2024

Study Start

November 13, 2023

Primary Completion

April 25, 2024

Study Completion

June 23, 2024

Last Updated

July 23, 2024

Record last verified: 2024-07

Locations