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Sponsored by: |
Department of Defense |
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Information provided by: | Walter Reed Army Medical Center |
ClinicalTrials.gov Identifier: | NCT00384371 |
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.
Condition | Intervention | Phase |
---|---|---|
Low Back Pain |
Drug: Botulinum Toxin A Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
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. |
Estimated Enrollment: | 60 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Botulinum Toxin A
|
Drug: Botulinum Toxin A
Botulinum Toxin A
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2: Placebo Comparator
Placebo
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Drug: Placebo
Placebo
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jack W Tsao, MD | 301-295-3643 | jtsao@usuhs.mil |
Contact: Erin K Murphy, MS | 202-782-9766 | erin.murphy@amedd.army.mil |
United States, District of Columbia | |
Walter Reed Army Medical Center | |
Washington, District of Columbia, United States, 20307 |
Principal Investigator: | Jack W Tsao, MD | Walter Reed Army Medical Center |
Responsible Party: | Walter Reed Army Medical Center ( CDR Jack W. Tsao, MD, DPhil ) |
Study ID Numbers: | DCI P05-71030 |
Study First Received: | October 4, 2006 |
Last Updated: | February 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00384371 |
Health Authority: | United States: Federal Government |
back pain |
Signs and Symptoms Botulinum Toxins Neurologic Manifestations Low Back Pain |
Pain Botulinum Toxin Type A Back Pain |
Anti-Dyskinesia Agents Therapeutic Uses Nervous System Diseases Central Nervous System Agents Pharmacologic Actions |