Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00279903
Status:
COMPLETED
Last Update Posted:
2012-11-07
First Post:
2006-01-18
Brief Title:
Is Botox Effective in Relieving Pain From Knee Osteoarthritis
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Intra-articular Botulinum Toxin Type-A in Knee Osteoarthritis - a Randomized Cortisone Controlled Double Blind Study
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with painful knee osteoarthritis will be randomly allocated to one of three groups Each group will receive a knee injection of 1 cortisone 2 low dose Botox or 3 high dose Botox Patients will then be followed for 6 months to see if they have significant pain relief or improvement in their activity level after the injection
Detailed Description:
Abstract Botulinum toxin type A Btx-A has been extensively studied and used clinically for its muscle paralyzing effects but there is a growing body of evidence to support a role in pain modulation Symptomatic osteoarthritis is a leading cause of pain functional impairment and disability with significant indirect costs to society Preliminary evidence suggests that Btx-A has a significant nociceptive effect when injected intra-articularly in to painful joints The proposed study will evaluate the efficacy and safety of Btx-A injected intra-articularly in 60 subjects with moderate pain and functional impairment secondary to knee osteoarthritis in a randomized cortisone-controlled double blind study over a 6 month follow up period If Btx-A is shown to be of equal or greater efficacy than cortisone in this patient population it may be an excellent second line treatment for osteoarthritis in multiple joints where surgery is contraindicated or deferred due to age comorbidities or patient preference Further studies examining the mechanism of action at the biochemical level the clinical effect of Btx-A in other joints in both osteoarthritis and inflammatory arthritis the efficacy of Btx-A compared to hyaluronic acid the only currently available injectable alternative to cortisone and the side effect profile effect on adjacent muscle strength joint position sense and long-term outcomes would be indicated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None