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Sponsored by: |
Walter Reed Army Medical Center |
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Information provided by: | Walter Reed Army Medical Center |
ClinicalTrials.gov Identifier: | NCT00404417 |
This study will assess the efficacy and the duration of efficacy of Botulinum toxin A (Botox®) injected into the lumbar paraspinal muscles for reducing pain and disability in subjects suffering from chronic low back pain of six months duration or longer and arising from an identifiable muscle strain injury or back trauma. The treatment modality and techniques used are based on a successful prior 4 month open-labeled pilot study done by this research group, but will employ a prospective double-blind, randomized, cross-over design to control for any placebo or mechanical trigger-point injection effects. Subjects will also be assessed for a longer duration to better define the duration of efficacy.
Condition | Intervention | Phase |
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Chronic Low Back Pain |
Drug: Botulinum Toxin A / Placebo Drug: Botulinum Toxin A / Botulinum Toxin A Drug: Placebo / Botulinum Toxin A Drug: Placebo / Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Botulinum Toxin A for the Treatment of Chronic Lumbar Back Pain: A Prospective Randomized Double-Blind Placebo-Controlled Crossover Study |
Estimated Enrollment: | 160 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Botox/Placebo
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Drug: Botulinum Toxin A / Placebo
Botulinum Toxin A at first injection / Placebo at second injection
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2: Experimental
Botox/Botox
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Drug: Botulinum Toxin A / Botulinum Toxin A
Botulinum Toxin A at first injection / Botulinum Toxin A at second injection
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3: Experimental
Placebo/Botox
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Drug: Placebo / Botulinum Toxin A
Placebo at first injection / Botulinum Toxin A at second injection
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4: Placebo Comparator
Placebo/Placebo
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Drug: Placebo / Placebo
Placebo at first injection / Placebo at second injection
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One hundred sixty subjects will be randomly assigned to one of four arms (placebo/placebo, placebo/Botox, Botox/placebo, Botox/Botox). In the first of two phases, randomized subjects will blindly receive either Botox® (study arms Botox/placebo and Botox/Botox) or placebo (study arms placebo/placebo and placebo/Botox) injection into the lumbar paraspinal muscles. The subjects will be assessed using validated scales for pain and disability prior to injection and monthly thereafter for four months. In the second phase, a second set of lumbar injections will be administered based on the initial randomization and will blindly receive either Botox® (study arms placebo/Botox and Botox/Botox) or placebo (study arms placebo/placebo and Botox/placebo) injection into the lumbar paraspinal muscles. The subjects will again be assessed using the same validated scales for pain and disability, prior to injection and monthly thereafter, but for six months to extend the monitoring period to better define the limits of duration of effect.
This will result in half of the subjects being crossed-over from Botox® to placebo (study arm Botox/placebo) or vice versa (study arm placebo/Botox) and one quarter of subjects receiving two courses of either Botox® alone (Botox/Botox) or placebo alone (placebo/placebo). All subjects will continue to receive medication and/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 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kevin R Cannard, MD | 202-782-3282 | Kevin.Cannard@na.amedd.army.mil |
Contact: Erin K Murphy, MS | 202-782-9766 | erin.murphy@amedd.army.mil |
United States, District of Columbia | |
Walter Reed Army Medical Center | Recruiting |
Washington, District of Columbia, United States, 20307 | |
Principal Investigator: Kevin R Cannard, MD |
Principal Investigator: | Kevin R Cannard, MD | Walter Reed Army Medical Center |
Responsible Party: | Walter Reed Army Medical Center ( COL Kevin R. Cannard, MD ) |
Study ID Numbers: | DCI P06-71038 |
Study First Received: | November 27, 2006 |
Last Updated: | February 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00404417 |
Health Authority: | United States: Federal Government |
pain lumbar |
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 |