NCT03308279

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

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

September 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

October 7, 2017

Last Update Submit

October 12, 2017

Conditions

Keywords

dry needlingmedian nervePronator Teres

Outcome Measures

Primary Outcomes (4)

  • Muscle thicknesses

    With ultrasound

    10 minutes

  • Median Nerve depth

    With ultrasound

    5 minutes

  • Forearm Perimeter

    in cm

    2 minutes

  • Forearm Longitude

    in cm

    2 minutes

Study Arms (1)

Asinthomatic

The only group evaluated

Diagnostic Test: Ultrasound

Interventions

UltrasoundDIAGNOSTIC_TEST

Ultrasound and Anthropometric meassures

Also known as: Anthropometric meassures
Asinthomatic

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Asinthomatic subjets who respond to the researchers calls

You may qualify if:

  • Asinthomatic subjets

You may not qualify if:

  • Pain in the 3 moths before in the forearm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 27843079BACKGROUND
  • 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.

    PMID: 19969200BACKGROUND
  • 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.

    PMID: 26674101BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Raúl Ferrer Peña

Study Record Dates

First Submitted

October 7, 2017

First Posted

October 12, 2017

Study Start

September 1, 2016

Primary Completion

June 30, 2017

Study Completion

August 15, 2017

Last Updated

October 13, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share