Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437762
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2007-02-19
Brief Title:
Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Effectiveness of Botulinum Toxin A Injection for the Treatment of Lateral Epicondylitis Unrelieved by Usual Medical Cares A Double Blind Randomized Controlled Trial Versus Placebo
Status:
COMPLETED
Status Verified Date:
2013-02
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:
TBA
Brief Summary:
Some studies valued the effectiveness of botulinum toxin Results are contradictory and we need more studies The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months Method It is a double blind randomized controlled trial Principal criteria of assessment is Pain intensity three months after injection
Detailed Description:
Principal Objective The first aim of the study is to value the effectiveness of botulinum toxin injection in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months
Secondary Objective The second aim of this study is to document the tennis elbow history by a one year following after initial injection
Study design It is a double blind randomized controlled trial Principal criteria of assessment is Pain intensity three months after injection
Inclusion criteria tennis elbow during more than 6 months signature of consent
Exclusion criteria Non inclusion criteria less than 18 years old osteoarthritis elbow referred cervical pain fibromyalgia pregnancy myasthenia polymyositis SLA anticoagulant treatment aminosides diabetes alcoholism
Study plan randomized parallel groups
Number of subjects 60
Secondary Objective The second aim of this study is to document the tennis elbow history by a one year following after initial injection
Study design It is a double blind randomized controlled trial Principal criteria of assessment is Pain intensity three months after injection
Inclusion criteria tennis elbow during more than 6 months signature of consent
Exclusion criteria Non inclusion criteria less than 18 years old osteoarthritis elbow referred cervical pain fibromyalgia pregnancy myasthenia polymyositis SLA anticoagulant treatment aminosides diabetes alcoholism
Study plan randomized parallel groups
Number of subjects 60
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