How Much Can the Thoracic and Lumbar Skin Slide?

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: Movement of Thoracic and Lumbar Skin
• Intervention / Treatment: Other: measure of skin movement on surface of the back; Other: Measurement of skin movement on surface of back

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

20

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	Data entered day subject participates

Collaborators and Investigators

• 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

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: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: 2013003345