Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT00435318
Status:
WITHDRAWN
Last Update Posted:
2015-12-08
First Post:
2007-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT)
Sponsor:
Vanderbilt University
Organization:
Study Overview
Official Title:
Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT)
Status:
WITHDRAWN
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study approval deferred by the IRB.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The intent of this double-blinded study is to investigate the short (2 months) and long-term (over 2 months) therapeutic capabilities of Iontophoresis.
Detailed Description:
The intent of this double-blinded study is to investigate the short (2 months) and long-term (over 2 months) therapeutic capabilities of Iontophoresis. We anticipate that patients treated with Iontophoresis will have improved scores on the VAS and DASH assessments, and will recover more quickly than those patients receiving the Sham treatment. A Sham treatment is a method used in medical trials to help researchers determine the effectiveness of a drug/treatment which in this case will be Iontophoretic Administration using Dexamethasone. Placebos are inactive substances (Saline) used in this study to compare results with an active substance (Dexamethasone). Furthermore, it is the hope of this research team that through careful analysis and comparison of these two treatment arms a clear conclusion is met regarding the efficacy of Iontophoresis as a powerful treatment paradigm for patients suffering from this disorder.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: