How Much Can the Thoracic and Lumbar Skin Slide?

July 26, 2019 updated by: Enrique Pantin, Rutgers, The State University of New Jersey

How Much Can the Thoracic and Lumbar Skin Slide? Unrecognized Cause of Epidural Catheter Placement Failure

The investigators want to determine how much the skin on the back can move left to right of the midline and also up and down, in subjects presenting for procedure or in healthy volunteers. The investigators will do measurements on the back using samples of individuals in all age groups.

It is hypothesized that an explanation to late epidural failure could be related to excess back motion in individual subjects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson Universtiy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All individuals age 0-100

Description

Inclusion Criteria:

  1. Children age 0-17 and Adults 18 and older may participate
  2. You agree to participate and sign the informed consent document

Exclusion Criteria:

  1. Any type of back deformity
  2. Tumor on back
  3. Skin Disease on the back
  4. Any condition that prevents skin measurements such as scleroderma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Age 11-15
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 16-20
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 21-25
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 26-30
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 31-35
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 36-40
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 41-45
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 46-50
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 51-55
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 56-60
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
age 61-65
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 66-70
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 71-75
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 76-80
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 81-85
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 86-90
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 91-95
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 96-100
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 0-5
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back
Age 6-10
Other: measure of skin movement on surface of the back
Other: Measurement of skin movement on surface of back

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lumbar skin move greater than 4 cm laterally or cephala-caudal
Time Frame: Data entered day subject participates
Data entered day subject participates

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Enrique Pantin, MD, Rutgers Robert Wood Johnson Medical School
  • Study Chair: Ann Marie Lozano, RN, MSN, Rutgers Robert Wood Johnson Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

February 25, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Actual)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 26, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013003345

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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