Pilot Study to Assess the Efficacy of Botulinum Toxin B on Pain and Disability in Subjects With Acute Low Back Pain

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00384579
• Date of registration: 04/10/2006
• Primary sponsor: Department of Defense
• Public title: Pilot Study to Assess the Efficacy of Botulinum Toxin B on Pain and Disability in Subjects With Acute Low Back Pain
• Scientific title: Pilot Study to Assess the Efficacy of Botulinum Toxin B (Myobloc®) Treatment of Paravertebral Muscles on Pain and Disability in Subjects Suffering From Acute Low Back Pain
• Date of first enrolment: February 2008
• Target sample size: 0
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00384579
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jack W Tsao, MD
• Affiliation: Walter Reed Army Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female subjects, 18 to 60 years of age, active duty military, retired
military or other DOD beneficiaries eligible for care at military treatment
facilities.

- 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.

- Evidence of trigger point tenderness or muscle spasm upon palpation or EMG findings
of muscle spasm.

- History of low back pain lasting 3 to 6 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
Myobloc®, 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 < 3 weeks or > 6 weeks.

- Thoracic or cervical spine pain in the absence of 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 Myobloc®, Dysport®, or BOTOX®.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Low Back Pain

Intervention(s)

Drug: Botulinum toxin B

Drug: Placebo

Primary Outcome(s)

Significant improvement in lower back pain [Time Frame: 8 weeks]

Secondary Outcome(s)

Significant reduction of long term disability [Time Frame: 12 weeks]

Secondary ID(s)

DCI P05-71031

Source(s) of Monetary Support

Please refer to primary and secondary sponsors