Pronator Teres Nerve SyndromeNCT03308279

Prediction Model for Minimizing the Risk of Median Nerve Puncture

An observational study of Pronator Teres Nerve Syndrome, run by Universidad Autonoma de Madrid.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Pronator Teres Nerve Syndrome
What is being tested?: Ultrasound
How many people: 65 participants
Where: No sites listed yet
Study dates: 1 Sep 2016to 15 Aug 2017
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
Adult, Older adult

Study population: Asinthomatic subjets who respond to the researchers calls

Who may be able to join

Asinthomatic subjets

Who cannot join

Pain in the 3 moths before in the forearm

About this study

Official title: Ultrasound and Anthropometric Prediction Model for Minimizing the Risk of Median Nerve Puncture With Dry Needling Approach Into the Pronator Teres Muscle

The main aim of this study was to correlate anthropometric measures of the forearm in healthy subjects with the ultrasound pronator teres depth to determine the needle length in order to avoid injury of the median nerve during pronator teres dry needle approach. A cross-sectional study, was carried out in order to perform a predictive model for the median nerve depth into the pronator teres muscle using a decision tree analysis algorithm.

Conditions: Pronator Teres Nerve Syndrome
Being tested: Ultrasound
Keywords: dry needling, median nerve, Pronator Teres

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UltrasoundDiagnostic test
Also called Anthropometric meassures
Ultrasound and Anthropometric meassures

Study groups in NCT03308279
Study group	Role	What they receive
Asinthomatic		The only group evaluated Receives: Diagnostic Test: Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

Muscle thicknesses
With ultrasound
Measured: 10 minutes
Median Nerve depth
With ultrasound
Measured: 5 minutes
Forearm Perimeter
in cm
Measured: 2 minutes
Forearm Longitude
in cm
Measured: 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201615 Aug 2017

First posted12 Oct 2017
Study start1 Sep 2016
Primary completion30 Jun 2017
Study completion15 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Pronator Teres Nerve SyndromeStudies 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: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03308279
Sponsor's protocol ID: Pronator Teres Prediction
Status last verified: Oct 2017
First submitted: 7 Oct 2017
Last updated: 13 Oct 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gurses IA, Altinel L, Gayretli O, Akgul T, Uzun I, Dikici F. Morphology and morphometry of the ulnar head of the pronator teres muscle in relation to median nerve compression at the proximal forearm. Orthop Traumatol Surg Res. 2016 Dec;102(8):1005-1008. doi: 10.1016/j.otsr.2016.08.016. Epub 2016 Nov 11.
PubMed 27843079
Dang AC, Rodner CM. Unusual compression neuropathies of the forearm, part II: median nerve. J Hand Surg Am. 2009 Dec;34(10):1915-20. doi: 10.1016/j.jhsa.2009.10.017.
PubMed 19969200
Kowalska B, Sudol-Szopinska I. Ultrasound assessment on selected peripheral nerve pathologies. Part I: Entrapment neuropathies of the upper limb - excluding carpal tunnel syndrome. J Ultrason. 2012 Sep;12(50):307-18. doi: 10.15557/JoU.2012.0016. Epub 2012 Sep 30.
PubMed 26674101

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultrasound and Anthropometric Prediction Model for Minimizing the Risk of Median Nerve Puncture With Dry Needling Approach Into the Pronator Teres Muscle
ClinicalTrials.gov ID: NCT03308279
Acronym / sponsor ID: Pronator Teres Prediction
Conditions: Pronator Teres Nerve Syndrome
Keywords: dry needling, median nerve, Pronator Teres
Study type: Observational
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Universidad Autonoma de MadridUniversity, hospital or other
Study start: 1 Sep 2016 (actual)
Primary completion: 30 Jun 2017 (actual)
Study completion: 15 Aug 2017 (actual)
First posted: 12 Oct 2017 (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.

Study design

Observational model: Other
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Asinthomatic	–	Diagnostic Test: UltrasoundThe only group evaluated

Who may qualify

Ages: 18 to 65 years
Sex: All
Age groups: Adult, Older adult
Study population: Asinthomatic subjets who respond to the researchers calls

Key inclusion criteria (1 listed)

Asinthomatic subjets

Key exclusion criteria (1 listed)

Pain in the 3 moths before in the forearm

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
UltrasoundAlso: Anthropometric meassuresUltrasound and Anthropometric meassures	Diagnostic test	Asinthomatic

Primary outcome

Muscle thicknesses
Time frame: 10 minutes
With ultrasound
Median Nerve depth
Time frame: 5 minutes
With ultrasound
Forearm Perimeter
Time frame: 2 minutes
in cm
Forearm Longitude
Time frame: 2 minutes
in cm

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 13 Oct 2017.
Background: PubMed 27843079Gurses IA, Altinel L, Gayretli O, Akgul T, Uzun I, Dikici F. Morphology and morphometry of the ulnar head of the pronator teres muscle in relation to median nerve compression at the proximal forearm. Orthop Traumatol Surg Res. 2016 Dec;102(8):1005-1008. doi: 10.1016/j.otsr.2016.08.016. Epub 2016 Nov 11.
Background: PubMed 19969200Dang AC, Rodner CM. Unusual compression neuropathies of the forearm, part II: median nerve. J Hand Surg Am. 2009 Dec;34(10):1915-20. doi: 10.1016/j.jhsa.2009.10.017.
Background: PubMed 26674101Kowalska B, Sudol-Szopinska I. Ultrasound assessment on selected peripheral nerve pathologies. Part I: Entrapment neuropathies of the upper limb - excluding carpal tunnel syndrome. J Ultrason. 2012 Sep;12(50):307-18. doi: 10.15557/JoU.2012.0016. Epub 2012 Sep 30.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Pronator Teres Nerve Syndrome, run by Universidad Autonoma de Madrid.

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 1 inclusion and 1 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 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Muscle thicknesses (time frame: 10 minutes). The study lists 4 primary outcomes in all. 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 NCT03308279, which also lists 3 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 13 Oct 2017.