Injecting Botulinum Toxin A Underneath the Skin to Treat Spinal Cord Pain in Patients With Spinal Cord Injury

In this study, there will be 2 procedure performed. The first procedure will be named P1 and
consists of subcutaneous injection of either placebo or Botulinum Toxin A. The second
procedure will be the cross-over procedure named P2. For the cross-over procedure, the
subjects who had initially received Botulinum Toxin A will receive placebo and the subjects
who had initially received placebo will receive Botulinum Toxin A. This is a Randomized
Double-Blinded Placebo Controlled Trial. Recruited subjects will be consented, enrolled and
evaluated immediately prior to P1 (or during a visit prior to the visit for P1). After the
initial pre-treatment evaluation, subjects will randomly receive either placebo or Botulinum
Toxin A subcutaneously (P1). A telephone follow-up (or e-mail follow up) will be performed at
2 weeks and 8 weeks post- P1. An onsite follow up will be performed 4 weeks post P1 and 12
weeks post P1.

Cross-over Study: After the 3rd month on-site evaluation (12 weeks post P1), during the same
visit, the subject will proceed to the cross-over study. At this time, the patient will have
the option to receive a repeat subcutaneous injection of the cross-over agent. If they desire
one, a subcutaneous injection of the cross-over agent will be performed at that same visit.
If they wish to defer the repeat injection, they will be contacted and asked every 4 weeks -
between 12 weeks and 24 weeks post P1 (no subject will receive P2 after week 24) if they
would like to have the subcutaneous injection of the cross-over agent. If they desire one, a
repeat injection will be scheduled for the following week.

The rationale for a variable length of time after the initial Botulinum Toxin A/Placebo
injection (P1) is to document the variability of individuals' pain response after Botulinum
Toxin A. It has been reported in literature, of the subjects that respond to subcutaneous
Botulinum Toxin A injections for pain, most will return to their base-line pain score in
12--24 weeks.

Inclusion Criteria:

- Between the ages of 18 and 80 years old

- Diagnosed with traumatic spinal cord injury

- Target pain is considered by the physician as at-level SCI in nature to a high degree
of certainty (4 or 5 using a Likert confidence scale ranging from 0-5 where 0 is
"purely a guess" and 5 is "absolutely certain")

- Able to give written informed consent

- Target pain that has been continuously present for at least one month

- Target pain is of at least moderate average intensity over the past week, e.g.,
greater than or equal to 4/10 on a numeric rating scale, the cutoff point for moderate
pain in an SCI population.

- Target pain is localized within the dermatome which identifies the NLI or within 3
levels below the NLI

- Subject has been on a stable dose of analgesic mediation (or not on analgesic
medication) for at least 3 weeks and is agreeable to remaining on current regimen for
the duration of the study (previous prescribed breakthrough analgesics will be
allowed)

Exclusion Criteria:

- Pregnancy

- History of intolerance, hypersensitivity or known allergy to botulinum toxin or its
preservatives

- History of intolerance, hypersensitivity or known allergy to EMLA cream
(lignocaine/prilocaine eutectic mixture) which is used as an analgesic during BoNT
injection

- Recent history of administration of botulinum toxin (within previous 6 months)

- Contraindications to botulinum toxin (myasthenia gravis or other disease of the
neuromuscular junction)

- Coagulation disorder

- Current infection

- Insufficient command of English to complete self-report instruments.