Abnormality, CongenitalMA-TP-PLNCT06448832
Relationship of Muscular Agenesis: Thin Plantar and Palmar Long as a Biomarker of Injury and Performance Marker in the Lower Limb and Upper Limb Respectively
An observational study of Abnormality, Congenital, run by University of Seville at 1 site in Spain.
Trial summary
This study investigates muscle agenesis, specifically the absence of the palmaris longus and plantaris muscles, and its effects on injury risk, strength, and performance. Muscle injuries are common in sports, and the presence or absence of certain muscles can impact biomechanics and injury susceptibility. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Abnormality, Congenital
- What is being tested?
- Ultrasound
- How many people
- 132 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to 31 Jan 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with and without muscle agenesis.
Who may be able to join
- Individuals who lead a sedentary lifestyle or who are not used to doing physical training on a regular basis (more than 2 h/week).
- People between 18 and 80 years old.
Who cannot join
- Individuals with an ongoing oncological process.
- People with an active infectious process.
- Subjects with psychiatric disorders.
- Individuals with intellectual disorders that prevent understanding of the intervention.
- People with judicial incapacity.
- Patients diagnosed with fibromyalgia.
- Pregnancy or probability of pregnancy.
- Individuals with sensory impairments in the hand that prevent manual pressure.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Campus Científico-Tecnológico UAH. Av. de León, 3A, Alcalá de Henares, Madrid
Alcalá de Henares, Madrid, 28804
Alvaro Garcia-Luna, MSc, +34646777034, alvaro.garci@edu.uah.es
About this study
This study investigates muscle agenesis, specifically the absence of the palmaris longus and plantaris muscles, and its effects on injury risk, strength, and performance. Muscle injuries are common in sports, and the presence or absence of certain muscles can impact biomechanics and injury susceptibility. The study involves 132 subjects, divided into those with and without muscle agenesis, assessing injuries with the Nordic and CMDQ questionnaires and measuring strength with dynamometers. Results aim to clarify the controversial impact of muscle agenesis on functional disability and performance adaptation in the scientific literature.
Read the detailed description
Background. This study examines muscle agenesis, a congenital condition that involves the absence of a muscle, focusing on the palmaris longus and plantaris muscles. The prevalence of palmaris longus agenesis varies significantly, and there is debate about whether its absence results in functional disability or is a predictor of injuries. Muscle injuries account for one-third of sports injuries and more than 30% of all musculoskeletal system injuries. The presence or absence of certain muscles can influence the body's biomechanics and, therefore, susceptibility to injuries, as muscles play a crucial role in generating force and coordination, hence movement. The absence of certain muscles may require other muscles to compensate, which could affect the efficiency and performance capacity in certain body areas. However, in many cases, the absence of a muscle may not have a significant effect on performance, as other muscles can adapt to perform its function. This study seeks to provide clarity in this area of research due to the existing controversy in the scientific literature.
Objectives. To determine if muscle agenesis influences the development of injuries and its impact on strength and performance.
Material and methods. An observational analytical cross-sectional study was conducted with 132 subjects divided into one group of 66 subjects with muscle agenesis and another group of 66 subjects without muscle agenesis. The primary variable is the presence of upper and lower limb injuries measured using the Nordic and CMDQ questionnaires, and the secondary variable is upper limb strength measured with a dynamometer in palmar flexion and hand grip tests; and lower limb strength measured with a dynamometer in plantar flexion and vertical jump tests. The measurements were taken over 1 hour and 30 minutes during two days, with a 48-hour interval between the measurements of the upper and lower limbs.
- Conditions
- Abnormality, Congenital
- Being tested
- Ultrasound
- Keywords
- muscle agenesis, thin plantar, force, injuries, musculoskeletal palmar long, performance
- Medical subject headings
- Congenital Abnormalities, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
An ultrasound examination of the musculature of the plantar muscle and long palmar muscle is performed to determine their presence or absence.
| Study group | Role | What they receive |
|---|---|---|
| Agenesis Group | Subjects with the presence of muscular agenesis of the plantar muscle and palmaris longus. Receives: Diagnostic Test: Ultrasound | |
| Non-agenesis Group | Subjects without the presence of muscular agenesis of the plantar muscle and palmaris longus. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of injury
Presence of injury related to the upper and lower limb.
Measured: At the start of the study (at baseline, 0 week).
Secondary outcomes (1)
Strength
Upper and lower limb strength
Measured: At the start of the study (at baseline, 0 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Abnormality, CongenitalStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JJ JIMENEZ-REJANO, University of Seville
- Investigators
- Alvaro Garcia-Luna, MSc, Principal investigator, University of AlcalaJose-Jesus Jimenez-Rejano, PhD, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448832
- Sponsor's protocol ID
- Muscular Agenesis Thin plantar
- Acronym
- MA-TP-PL
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balsalobre-Fernandez C, Glaister M, Lockey RA. The validity and reliability of an iPhone app for measuring vertical jump performance. J Sports Sci. 2015;33(15):1574-9. doi: 10.1080/02640414.2014.996184. Epub 2015 Jan 2.
PubMed 25555023Ioannis D, Anastasios K, Konstantinos N, Lazaros K, Georgios N. Palmaris Longus Muscle's Prevalence in Different Nations and Interesting Anatomical Variations: Review of the Literature. J Clin Med Res. 2015 Nov;7(11):825-30. doi: 10.14740/jocmr2243w. Epub 2015 Sep 25.
PubMed 26491493Vanhoenacker FM, Desimpel J, Mespreuve M, Tagliafico A. Accessory Muscles of the Extremities. Semin Musculoskelet Radiol. 2018 Jul;22(3):275-285. doi: 10.1055/s-0038-1641575. Epub 2018 May 23.
PubMed 29791956Martinoli C, Perez MM, Padua L, Valle M, Capaccio E, Altafini L, Michaud J, Tagliafico A. Muscle variants of the upper and lower limb (with anatomical correlation). Semin Musculoskelet Radiol. 2010 Jun;14(2):106-21. doi: 10.1055/s-0030-1253155. Epub 2010 May 18.
PubMed 20486022Eric M, Koprivcic I, Vucinic N, Radic R, Krivokuca D, Leksan I, Selthofer R. Prevalence of the palmaris longus in relation to the hand dominance. Surg Radiol Anat. 2011 Aug;33(6):481-4. doi: 10.1007/s00276-010-0751-0. Epub 2010 Nov 24.
PubMed 21107568Dabrowski K, Stankiewicz-Jozwicka H, Kowalczyk A, Markuszewski M, Ciszek B. Musculus Palmaris Longus: Influence on Playing Capability of Keyboard Musicians - Preliminary Report. Front Psychol. 2018 Aug 13;9:1460. doi: 10.3389/fpsyg.2018.01460. eCollection 2018.
PubMed 30150961Vucinic N, Eric M, Savic M. How often absence of palmaris longus and functional deficiencyof flexor digitorum superficialis occurs ? Acta Orthop Belg. 2016 Aug;82(2):405-411.
PubMed 27682306Amaral JF, Mancini M, Novo Junior JM. Comparison of three hand dynamometers in relation to the accuracy and precision of the measurements. Rev Bras Fisioter. 2012 Jun;16(3):216-24. doi: 10.1590/s1413-35552012000300007.
PubMed 22801514Chamorro C, Armijo-Olivo S, De la Fuente C, Fuentes J, Javier Chirosa L. Absolute Reliability and Concurrent Validity of Hand Held Dynamometry and Isokinetic Dynamometry in the Hip, Knee and Ankle Joint: Systematic Review and Meta-analysis. Open Med (Wars). 2017 Oct 17;12:359-375. doi: 10.1515/med-2017-0052. eCollection 2017.
PubMed 29071305Pua YH, Wrigley TV, Cowan SM, Bennell KL. Intrarater test-retest reliability of hip range of motion and hip muscle strength measurements in persons with hip osteoarthritis. Arch Phys Med Rehabil. 2008 Jun;89(6):1146-54. doi: 10.1016/j.apmr.2007.10.028.
PubMed 18503813Arnold CM, Warkentin KD, Chilibeck PD, Magnus CR. The reliability and validity of handheld dynamometry for the measurement of lower-extremity muscle strength in older adults. J Strength Cond Res. 2010 Mar;24(3):815-24. doi: 10.1519/JSC.0b013e3181aa36b8.
PubMed 19661831
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Muscular Agenesis: Thin Plantar and Palmar Long as a Biomarker of Injury and Performance Marker in the Lower Limb and Upper Limb Respectively
- ClinicalTrials.gov ID
- NCT06448832
- Acronym / sponsor ID
- MA-TP-PL / Muscular Agenesis Thin plantar
- Conditions
- Abnormality, Congenital
- Keywords
- muscle agenesis, thin plantar, force, injuries, musculoskeletal palmar long, performance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 7 Jun 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.
This study investigates muscle agenesis, specifically the absence of the palmaris longus and plantaris muscles, and its effects on injury risk, strength, and performance. Muscle injuries are common in sports, and the presence or absence of certain muscles can impact biomechanics and injury susceptibility. The study involves 132 subjects, divided into those with and without muscle agenesis, assessing injuries with the Nordic and CMDQ questionnaires and measuring strength with dynamometers. Results aim to clarify the controversial impact of muscle agenesis on functional disability and performance adaptation in the scientific literature.
Detailed description
Background. This study examines muscle agenesis, a congenital condition that involves the absence of a muscle, focusing on the palmaris longus and plantaris muscles. The prevalence of palmaris longus agenesis varies significantly, and there is debate about whether its absence results in functional disability or is a predictor of injuries. Muscle injuries account for one-third of sports injuries and more than 30% of all musculoskeletal system injuries. The presence or absence of certain muscles can influence the body's biomechanics and, therefore, susceptibility to injuries, as muscles play a crucial role in generating force and coordination, hence movement. The absence of certain muscles may require other muscles to compensate, which could affect the efficiency and performance capacity in certain body areas. However, in many cases, the absence of a muscle may not have a significant effect on performance, as other muscles can adapt to perform its function. This study seeks to provide clarity in this area of research due to the existing controversy in the scientific literature.
Objectives. To determine if muscle agenesis influences the development of injuries and its impact on strength and performance.
Material and methods. An observational analytical cross-sectional study was conducted with 132 subjects divided into one group of 66 subjects with muscle agenesis and another group of 66 subjects without muscle agenesis. The primary variable is the presence of upper and lower limb injuries measured using the Nordic and CMDQ questionnaires, and the secondary variable is upper limb strength measured with a dynamometer in palmar flexion and hand grip tests; and lower limb strength measured with a dynamometer in plantar flexion and vertical jump tests. The measurements were taken over 1 hour and 30 minutes during two days, with a 48-hour interval between the measurements of the upper and lower limbs.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Agenesis Group | – | Diagnostic Test: UltrasoundSubjects with the presence of muscular agenesis of the plantar muscle and palmaris longus. |
| Non-agenesis Group | – | Diagnostic Test: UltrasoundSubjects without the presence of muscular agenesis of the plantar muscle and palmaris longus. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with and without muscle agenesis.
Key inclusion criteria (2 listed)
- Individuals who lead a sedentary lifestyle or who are not used to doing physical training on a regular basis (more than 2 h/week).
- People between 18 and 80 years old.
Key exclusion criteria (8 listed)
- Individuals with an ongoing oncological process.
- People with an active infectious process.
- Subjects with psychiatric disorders.
- Individuals with intellectual disorders that prevent understanding of the intervention.
- People with judicial incapacity.
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 |
|---|---|---|
| UltrasoundAn ultrasound examination of the musculature of the plantar muscle and long palmar muscle is performed to determine their presence or absence. | Diagnostic test | Agenesis Group, Non-agenesis Group |
Primary outcome
Presence of injury
Time frame: At the start of the study (at baseline, 0 week).
Presence of injury related to the upper and lower limb.
1 secondary outcome
Strength
Time frame: At the start of the study (at baseline, 0 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Background: PubMed 25555023Balsalobre-Fernandez C, Glaister M, Lockey RA. The validity and reliability of an iPhone app for measuring vertical jump performance. J Sports Sci. 2015;33(15):1574-9. doi: 10.1080/02640414.2014.996184. Epub 2015 Jan 2.
- Background: PubMed 26491493Ioannis D, Anastasios K, Konstantinos N, Lazaros K, Georgios N. Palmaris Longus Muscle's Prevalence in Different Nations and Interesting Anatomical Variations: Review of the Literature. J Clin Med Res. 2015 Nov;7(11):825-30. doi: 10.14740/jocmr2243w. Epub 2015 Sep 25.
- Background: PubMed 29791956Vanhoenacker FM, Desimpel J, Mespreuve M, Tagliafico A. Accessory Muscles of the Extremities. Semin Musculoskelet Radiol. 2018 Jul;22(3):275-285. doi: 10.1055/s-0038-1641575. Epub 2018 May 23.
- Background: PubMed 20486022Martinoli C, Perez MM, Padua L, Valle M, Capaccio E, Altafini L, Michaud J, Tagliafico A. Muscle variants of the upper and lower limb (with anatomical correlation). Semin Musculoskelet Radiol. 2010 Jun;14(2):106-21. doi: 10.1055/s-0030-1253155. Epub 2010 May 18.
- Background: PubMed 21107568Eric M, Koprivcic I, Vucinic N, Radic R, Krivokuca D, Leksan I, Selthofer R. Prevalence of the palmaris longus in relation to the hand dominance. Surg Radiol Anat. 2011 Aug;33(6):481-4. doi: 10.1007/s00276-010-0751-0. Epub 2010 Nov 24.
- Background: PubMed 30150961Dabrowski K, Stankiewicz-Jozwicka H, Kowalczyk A, Markuszewski M, Ciszek B. Musculus Palmaris Longus: Influence on Playing Capability of Keyboard Musicians - Preliminary Report. Front Psychol. 2018 Aug 13;9:1460. doi: 10.3389/fpsyg.2018.01460. eCollection 2018.
- Background: PubMed 27682306Vucinic N, Eric M, Savic M. How often absence of palmaris longus and functional deficiencyof flexor digitorum superficialis occurs ? Acta Orthop Belg. 2016 Aug;82(2):405-411.
- Background: PubMed 22801514Amaral JF, Mancini M, Novo Junior JM. Comparison of three hand dynamometers in relation to the accuracy and precision of the measurements. Rev Bras Fisioter. 2012 Jun;16(3):216-24. doi: 10.1590/s1413-35552012000300007.
- Background: PubMed 29071305Chamorro C, Armijo-Olivo S, De la Fuente C, Fuentes J, Javier Chirosa L. Absolute Reliability and Concurrent Validity of Hand Held Dynamometry and Isokinetic Dynamometry in the Hip, Knee and Ankle Joint: Systematic Review and Meta-analysis. Open Med (Wars). 2017 Oct 17;12:359-375. doi: 10.1515/med-2017-0052. eCollection 2017.
- Background: PubMed 18503813Pua YH, Wrigley TV, Cowan SM, Bennell KL. Intrarater test-retest reliability of hip range of motion and hip muscle strength measurements in persons with hip osteoarthritis. Arch Phys Med Rehabil. 2008 Jun;89(6):1146-54. doi: 10.1016/j.apmr.2007.10.028.
- Background: PubMed 19661831Arnold CM, Warkentin KD, Chilibeck PD, Magnus CR. The reliability and validity of handheld dynamometry for the measurement of lower-extremity muscle strength in older adults. J Strength Cond Res. 2010 Mar;24(3):815-24. doi: 10.1519/JSC.0b013e3181aa36b8.
- Individual participant dataSharing planned: No
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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.
Alvaro Garcia-Luna, MSc principal investigator
University of Alcala
Jose-Jesus Jimenez-Rejano, PhD principal investigator
University of Seville
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 Abnormality, Congenital, run by University of Seville 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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alvaro Garcia-Luna, MSc (+34646777034, alvaro.garci@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of injury (time frame: At the start of the study (at baseline, 0 week).). 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 NCT06448832, which also lists 11 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 7 Jun 2024.