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

• Status: Terminated
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: United States Department of Defense
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• 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 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®.