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

Exclusion Criteria

• •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®.