Overview

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®.