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CompletedNCT03308279Updated Oct 13, 2017

Prediction Model for Minimizing the Risk of Median Nerve Puncture

An observational study in Pronator Teres Nerve Syndrome, sponsored by Universidad Autonoma de Madrid. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-10-13.

Sponsored by Universidad Autonoma de Madrid · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
65
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pronator Teres Nerve Syndrome

Keywords

  • dry needling
  • median nerve
  • Pronator Teres
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Asinthomatic subjets who respond to the researchers calls

Inclusion criteria

  • Asinthomatic subjets

Exclusion criteria

Exclusion Criteria:

  • Pain in the 3 moths before in the forearm
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
65 participants (actual)
Patient registry
No

Groups and cohorts

  • Asinthomatic

    The only group evaluated

    Diagnostic Test: Ultrasound

Interventions

  • Diagnostic testUltrasound

    Ultrasound and Anthropometric meassures

    Also known as: Anthropometric meassures

05

What researchers measure

Primary outcomes

  1. Muscle thicknesses

    With ultrasound

    Time frame: 10 minutes

  2. Median Nerve depth

    With ultrasound

    Time frame: 5 minutes

  3. Forearm Perimeter

    in cm

    Time frame: 2 minutes

  4. Forearm Longitude

    in cm

    Time frame: 2 minutes

06

Study locations

No study locations are listed for this record.

07

References and documents

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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03308279
Lead sponsor
Universidad Autonoma de Madrid
Responsible party
Raúl Ferrer-Peña (Prof. Raúl Ferrer Peña, Universidad Autonoma de Madrid) — Principal investigator
First posted
Oct 12, 2017
Start date
Sep 1, 2016
Primary completion
Jun 30, 2017
Completion
Aug 15, 2017
Last update
Oct 13, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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