Movement of Thoracic and Lumbar Skin Clinical Trial
Official title:
How Much Can the Thoracic and Lumbar Skin Slide? Unrecognized Cause of Epidural Catheter Placement Failure
| NCT number | NCT02105363 |
| Other study ID # | 2013003345 |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 2014 |
| Est. completion date | April 2017 |
| Verified date | July 2019 |
| Source | Rutgers, The State University of New Jersey |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 400 |
| Est. completion date | April 2017 |
| Est. primary completion date | April 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Robert Wood Johnson Universtiy Hospital | New Brunswick | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Rutgers, The State University of New Jersey |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Lumbar skin move greater than 4 cm laterally or cephala-caudal | Data entered day subject participates |