Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384579
Status:
TERMINATED
Last Update Posted:
2010-03-02
First Post:
2006-10-04
Brief Title:
Pilot Study to Assess the Efficacy of Botulinum Toxin B on Pain and Disability in Subjects With Acute Low Back Pain
Sponsor:
United States Department of Defense
Organization:
Walter Reed Army Medical Center
Study Overview
Official Title:
Pilot Study to Assess the Efficacy of Botulinum Toxin B Myobloc Treatment of Paravertebral Muscles on Pain and Disability in Subjects Suffering From Acute Low Back Pain
Status:
TERMINATED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No eligible candidates in 2 years of recruiting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test the hypothesis that Botulinum toxin B Myobloc treatment reduces pain and disability in subjects suffering from acute low back pain due to an identifiable muscle strain or back trauma occurring 3 to 6 weeks prior to enrollment The study will also delineate the duration of medication effect and control for any placebo or mechanical trigger-point injection effect by employing a prospective double-blind placebo-controlled design
Detailed Description:
This study will assess the efficacy of Botulinum Toxin B Myobloc injected into the lumbar paravertebral muscles for reducing pain and disability in subjects suffering from acute low back pain duration 3 to 6 weeks arising from an identifiable muscle strain injury or back trauma The treatment modality and techniques used are based upon three successful prior open-labeled pilot studies done by this research group investigating the effect of Botulinum Toxin A BOTOX on relief of chronic low back pain This study however will employ a prospective double-blind randomized placebo controlled trial to control for any placebo or mechanical trigger-point injection effects Subjects will also be assessed for 3 months to define the duration of efficacy of Myobloc Sixty subjects will be randomly assigned to one of two groups and will then receive either Myobloc or placebo injection into the lumbar paravertebral muscles The subjects will be assessed using validated scales for pain and disability prior to injection and weekly to monthly thereafter for three months All subjects will continue to receive any medication or physiotherapy per standard of care but those treatments will be recorded and controlled for in the data analysis
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