Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT00211718
Status:
UNKNOWN
Last Update Posted:
2005-11-03
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intra-Articular Injection of Botulinum Toxin Type A for Shoulder Pain
Sponsor:
Minneapolis Veterans Affairs Medical Center
Organization:
Study Overview
Official Title:
Intra-Articular Injection of Botulinum Toxin Type A for the Treatment of Shoulder Pain: A Randomized, Double Blinded, Placebo Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether intra-articular botulinum toxin type A is effective in the treatment of chronic joint pain.
Detailed Description:
Chronic shoulder pain unresponsive to oral medications and intra-articular corticosteroids is an important treatment problem, especially for the young, very old and those with complex medical problems that preclude joint reconstructive surgery. We hypothesized that intra-articular botulinum toxin could provide important joint pain relief in these patients. This is a prospective, double blined, placebo controlled 6month trial with an open label extension phase when pain returns to baseline levels (re-injection with 100units of botulinum toxin and 6 months followup thereafter).
Comparisons: Intra-articular injection of botulinum toxin type a will be compared to intra-articular injection of placebo ( lidocaine then saline).
Comparisons: Intra-articular injection of botulinum toxin type a will be compared to intra-articular injection of placebo ( lidocaine then saline).
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?: