Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain

This is an investigator initiated, randomized, double blind, placebo-controlled study. A
total of 90 patients will be enrolled in the study. The study will be conducted over 4
months. It includes 4 visits and 4 telephone calls. Patients with chronic low back pain (>3
months) who meet inclusion and exclusion criteria and wish to participate in the study may
be enrolled. Those who become enrolled will be scheduled for a baseline visit (Week 0).
During the baseline visit, subjects will be given the official approved consent form to read
and ask questions. Participants to this study will also receive a copy of the Dysport Risk
Evaluation and Mitigation Strategy (REMS) statement. After obtaining informed consent signed
by the subject, the subjects will be randomization into the Dysport or placebo group. The
randomizing will be performed by a nurse and the information will be kept in a pass-worded
computer. Blinding means that neither the participant nor the clinical rater will know which
group the participant has been initially been assigned.

Each subject will have a neurological examination and fill a demographic form and complete
four rating questionnaires (appendix II-V). These include a visual analogue scale for pain
(0 to 10) and three quality of life questionnaires which depict quality of life (the
American Chronic Pain Association's Quality of Life Scale), how pain affects ability to
manage everyday life (Oswestry Low Back Pain Disability Questionnaire), and overall physical
and emotional health (Short Form-36). Patients will then receive an injection of either
abobotulinumA (Dysport) or normal saline. Dysport or saline will be administered into the
paraspinal muscles (extensors or erector spinae) at five levels (L1-L5), regardless of pain
location. In the case of unilateral pain, this would amount to 500 units total, and in the
case of bilateral pain, to 1000 units total, of Dysport per session.

Inclusion Criteria:

- Age 18-80, all ethnic groups, races, both sexes.

- Diagnosis of chronic low back pain (longer than 3 months).

- Pain of moderate to severe intensity (VAS 4 or higher).

- Subjects who are able to read, speak, and understand English.

Exclusion Criteria:

Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic,
neoplastic, infectious, or autoimmune disorders).

- Hypersensitivity to any botulinum toxin product or is recipient

- Allergy to albumin. Lactose or cow milk protein

- Infection in the proposed injection site.

- Pregnancy or planned pregnancy (determined by urine pregnancy test). The women of
childbearing age should use a reliable mode of contraception during the study period
(abstinence, etc).

- Active breast feeding.

- Enrollment in any clinical trial (currently or within the past 3 months) in which
treatments are imposed by a protocol.

- Patients taking high doses of aminoglycosides or other drugs affecting the function
of neuromuscular junction (anticholinergics , muscle relaxants)

- Subjects who are younger than 18 years of age.

- Neuromuscular-junction disorders and motor neuron disease such as Amyotrophic Lateral
Sclerosis.

- Evidence of acute pathology on neuro-imaging.

- Axis I diagnosis determined by a neurologist or psychiatrist.

- Anesthetic medications within two weeks and corticosteroid injections within 4 weeks
of enrollment.

- Received botulinum toxin injections in the past 3 months.

- History of low back surgery , evidence of acute disc or severe lumbar stenosis in MRI