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Neurotoxin

1 for Chronic Lower Back Pain

Phase 4
Waitlist Available
Led By Kevin R Cannard, MD
Research Sponsored by Walter Reed Army Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

Summary

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.

Eligible Conditions
  • Chronic Lower Back Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 3Experimental Treatment1 Intervention
Placebo/Botox
Group II: 2Experimental Treatment1 Intervention
Botox/Botox
Group III: 1Experimental Treatment1 Intervention
Botox/Placebo
Group IV: 4Placebo Group1 Intervention
Placebo/Placebo

Find a Location

Who is running the clinical trial?

Walter Reed Army Medical CenterLead Sponsor
69 Previous Clinical Trials
20,779 Total Patients Enrolled
Kevin R Cannard, MDPrincipal InvestigatorWalter Reed Army Medical Center
~9 spots leftby Nov 2025