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Botulinum Toxin A for the Treatment of Chronic Lumbar Back Pain

NCT00404417 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2010-03-02

No results posted yet for this study

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.

Conditions

  • Chronic Low Back Pain

Interventions

DRUG

Botulinum Toxin A / Placebo

Botulinum Toxin A at first injection / Placebo at second injection

DRUG

Botulinum Toxin A / Botulinum Toxin A

Botulinum Toxin A at first injection / Botulinum Toxin A at second injection

DRUG

Placebo / Botulinum Toxin A

Placebo at first injection / Botulinum Toxin A at second injection

DRUG

Placebo / Placebo

Placebo at first injection / Placebo at second injection

Sponsors & Collaborators

  • Walter Reed Army Medical Center

    lead FED

Principal Investigators

  • Kevin R Cannard, MD · Walter Reed Army Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00404417 on ClinicalTrials.gov