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Pilot Study to Assess the Efficacy of Botulinum Toxin A Treatments on Pain and Disability in Sub-Acute Low Back Pain

NCT00384371 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2009-03-05

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Interventions

DRUG

Botulinum Toxin A

Botulinum Toxin A

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • United States Department of Defense

    lead FED

Principal Investigators

  • Jack W Tsao, MD · Walter Reed Army Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00384371 on ClinicalTrials.gov