Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384371
Status:
TERMINATED
Last Update Posted:
2009-03-05
First Post:
2006-10-04
Brief Title:
Pilot Study to Assess the Efficacy of Botulinum Toxin A Treatments on Pain and Disability in Sub-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 A BOTOX Treatment of Paravertebral Muscles on Pain and Disability in Subjects Suffering From Sub-Acute Low Back Pain
Status:
TERMINATED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding was unable to be secured for this study
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 A BOTOX treatment reduces pain and disability in subjects suffering from sub-acute low back pain due to an identifiable muscle strain or back trauma occurring 6 to 16 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 A BOTOX injected into the lumbar paravertebral muscles for reducing pain and disability in subjects suffering from sub-acute low back pain duration 6 to 16 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 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 6 months to define the duration of efficacy of BOTOX Sixty subjects will be randomly assigned to one of two arms There will be two parts to this study In the first both groups will receive either BOTOX 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 Subjects who improve will have a single follow-up visit at 6 months while those subjects who do not improve will enter the second open-label part where they will receive BOTOX injection and be monitored weekly to monthly for the next 3 months giving a total subject participation period of 6 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