Trigger Point Pain, MyofascialNCT06514638
Computational Mathematical Analysis in Vastus Medialis Between a MTrP and Non Painful Point
An observational study of Trigger Point Pain, Myofascial, run by Samuel Fernández Carnero at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigger Point Pain, Myofascial
- What is being tested?
- Ultrasound imaging
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 13 Nov 2023to 23 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Students in the university were the main collection of subjects because of the proximity, but also other people recruited around the city.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Nursing and Physiotherapy Faculty Study Officials
Alcalá de Henares, Madrid, 28871
About this study
Official title: 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.
Read the 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.
- Conditions
- Trigger Point Pain, Myofascial
- Being tested
- Ultrasound imaging
- Keywords
- ultrasound, myofascial trigger point, vastus medialis
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound imagingOther
Images of the vastus medialis were taken with the subject being lateral decubitus.
| Study group | Role | What they receive |
|---|---|---|
| Study subjects | Helathy, 18-65 year old subjects with pain when fingerr pointed in the vastus medialis, without serious diseases. Receives: Other: Ultrasound imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echogenicity
Information measures of correlation at 0º, 45º, 90º, 135º expressed as mean+-standard deviation
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start13 Nov 2023
- Primary completion25 Apr 2024
- Study completion23 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Trigger Point Pain, MyofascialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Fernández Carnero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samuel Fernández Carnero, University of Alcala
- Investigators
- Carlos Tercero Mendoza, BSc, Principal investigator, University of AlcalaDavid Hernández Sánchez, BSc, Principal investigator, University of AlcalaDaniel Roldán Peña, BSc, Principal investigator, University of AlcalaNoe López Castellanos, BSc, Principal investigator, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514638
- Sponsor's protocol ID
- Vastus ultrasound MTRp
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yet to be decided, maybe collected as a part of a protocol to standarize.
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.
PubMed 19887205Hsieh 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.
PubMed 10724067Rathbone 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.
PubMed 28098584Martinez-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.
PubMed 28553752Kumbhare 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.
PubMed 26334421Nadeau 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.
PubMed 27540416Stock 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.
PubMed 33221942Schindelin 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.
PubMed 22743772
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Mathematical Analysis of the Texture of Muscle Tissue in Vastus Medialis Between a MTrP and a Non-painful Point
- ClinicalTrials.gov ID
- NCT06514638
- Acronym / sponsor ID
- Vastus ultrasound MTRp
- Conditions
- Trigger Point Pain, Myofascial
- Keywords
- ultrasound, myofascial trigger point, vastus medialis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Samuel Fernández CarneroUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 23 Jun 2024 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study subjects | – | Other: Ultrasound imagingHelathy, 18-65 year old subjects with pain when fingerr pointed in the vastus medialis, without serious diseases. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Students in the university were the main collection of subjects because of the proximity, but also other people recruited around the city.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound imagingImages of the vastus medialis were taken with the subject being lateral decubitus. | Other | Study subjects |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 19887205Sikdar 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.
- Background: PubMed 10724067Hsieh 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.
- Background: PubMed 28098584Rathbone 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.
- Background: PubMed 28553752Martinez-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.
- Background: PubMed 26334421Kumbhare 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.
- Background: PubMed 27540416Nadeau 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.
- Background: PubMed 33221942Stock 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.
- Background: PubMed 22743772Schindelin 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.
- 1\. Borg-Stein, J., \& Iaccarino, M. A. (2014). Myofascial pain syndrome treatments. Physical medicine and rehabilitation clinics of North AmericaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Yet to be decided, maybe collected as a part of a protocol to standarize.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Tercero Mendoza, BSc principal investigator
University of Alcala
David Hernández Sánchez, BSc principal investigator
University of Alcala
Daniel Roldán Peña, BSc principal investigator
University of Alcala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigger Point Pain, Myofascial, run by Samuel Fernández Carnero at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echogenicity (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06514638, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.