Status:
TERMINATED
Pilot Study to Assess the Efficacy of Botulinum Toxin A Treatments on Pain and Disability in Sub-Acute Low Back Pain
Lead Sponsor:
United States Department of Defense
Conditions:
Low Back Pain
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 bac...
Detailed Description
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 (du...
Eligibility Criteria
Inclusion
- Male or female subjects, 18 to 60 years of age, active duty military.
- Written informed consent and written authorization for use or release of health and research study information.
- Clear history of an identifiable muscle strain or trauma preceding the onset of low back pain.
- No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
- Normal neurological examination without evidence of radiculopathy.
- History of low back pain lasting 6 to 16 weeks from the time of injury or strain.
- VAS score minimum of 5 cm at time of entry into study.
- Ability to follow study instructions and likely to complete all required visits.
- Negative urine pregnancy test prior to the administration of study medication (for females of childbearing potential) (if applicable).
Exclusion
- Age less than 18 or greater than 60.
- Not active duty.
- Concomitant use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
- Any medical condition that may put the subject at increased risk with exposure to BOTOX®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis/motor neuron disease, neuropathy, renal stones, or any other disorder that might interfere with neuromuscular function or produce a similar type of low back pain.
- Females who are pregnant, breast-feeding, or planning a pregnancy during the study, or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Known allergy or sensitivity to any of the components in the study medication.
- Evidence of alcohol or substance abuse in 6 months prior to enrollment.
- Systemic medical conditions (such as thyroid disease, hypertension, bleeding disorders, diabetes, cancers, etc.) that are not currently medically managed or controlled.
- Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- Significant Axis I or II diagnosis determined by a neurologist or psychiatrist in the 6 months prior to entry into the study.
- Duration of low back pain \< 6 weeks or \> 16 weeks.
- Thoracic or cervical spine pain in the absence of sub-acute low back pain.
- Anesthetic or corticosteroid injection to the lumbosacral spine within 8 weeks of enrollment.
- Spine MRI (any region) positive for acute pathology or evidence of radiculopathy on neurological examination.
- History of back surgery within one year or incomplete resolution of back pain due to a previous injury or surgery.
- Subjects involved in litigation, seeking significant disability for low back pain, or with evident secondary gain as determined by the neurologist through chart review and subject interview.
- Any previous use of BOTOX®, Dysport®, or Myobloc®.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00384371
Start Date
June 1 2008
End Date
September 1 2011
Last Update
March 5 2009
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307