Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444886
Status:
COMPLETED
Last Update Posted:
2011-02-10
First Post:
2007-03-07
Brief Title:
Treatment of Thoracic Outlet Syndrome TOS With Botox
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Treatment of Thoracic Outlet Syndrome With Botulinum Toxin Injection A Double-Blind Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2011-02
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:
None
Brief Summary:
The purpose of this study is
1 To assess the effect of BOTOX injection to the scalene muscles on the severity of pain from TOS
2 To assess the effect of BOTOX injection on numbness and tingling and quality of life
1 To assess the effect of BOTOX injection to the scalene muscles on the severity of pain from TOS
2 To assess the effect of BOTOX injection on numbness and tingling and quality of life
Detailed Description:
Background
Thoracic Outlet Syndrome TOS is a symptom complex consisting of pain paresthesias and often functional impairment caused by compression of the neurovascular supply to the upper limb Impingement may occur at the interscalene triangle and both anesthetic blockade and chemodenervation of the scalene muscles have been shown to temporarily improve symptoms of TOS in non-randomized controlled trials
Objective
To assess the effect of Botulinum Toxin Type A BTX-A injections into the scalene muscles on pain paresthesias and function in subjects with TOS
Hypothesis
BTX-A injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with TOS This will lead to reductions in pain and paresthesias and improvements in function when compared with injection of placebo
Intervention
Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 75 units of BTX-A experimental group or normal saline control group Both groups will be provided with a stretching and strengthening exercise program
Thoracic Outlet Syndrome TOS is a symptom complex consisting of pain paresthesias and often functional impairment caused by compression of the neurovascular supply to the upper limb Impingement may occur at the interscalene triangle and both anesthetic blockade and chemodenervation of the scalene muscles have been shown to temporarily improve symptoms of TOS in non-randomized controlled trials
Objective
To assess the effect of Botulinum Toxin Type A BTX-A injections into the scalene muscles on pain paresthesias and function in subjects with TOS
Hypothesis
BTX-A injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with TOS This will lead to reductions in pain and paresthesias and improvements in function when compared with injection of placebo
Intervention
Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 75 units of BTX-A experimental group or normal saline control group Both groups will be provided with a stretching and strengthening exercise program
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Data not known | None | None | None |