Prediction Model for Minimizing the Risk of Median Nerve... | NCT03308279

Studies
Prediction Model for Minimizing the Risk of Median Nerve Puncture

NCT03308279

Sponsor

Universidad Autonoma de Madrid

Status

Completed

Last Update Posted

Oct 13, 2017Actual

Enrollment

65Actual

Phase

Not provided

Conditions

Pronator Teres Nerve Syndrome

Interventions

Ultrasound

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2016Actual

Primary Completion Date

Jun 30, 2017Actual

Completion Date

Aug 15, 2017Actual

First Submitted Date

Oct 7, 2017

First Submission Date that Met QC Criteria

Oct 7, 2017

First Posted Date

Oct 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2017

Last Update Posted Date

Oct 13, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Raúl Ferrer-Peña, Prof. Raúl Ferrer Peña, Universidad Autonoma de MadridPrincipal Investigator

Lead Sponsor

Universidad Autonoma de MadridOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Asinthomatic		The only group evaluated	Diagnostic Test: Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound	Diagnostic Test	Ultrasound and Anthropometric meassures	Asinthomatic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Asinthomatic subjets

Exclusion Criteria:

Pain in the 3 moths before in the forearm

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Asinthomatic subjets who respond to the researchers calls

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27843079	Background	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.
19969200	Background

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis