Injecting Botulinum Toxin A Underneath the Skin to Treat Spinal Cord Pain in Patients With Spinal Cord Injury
Condition: Neuropathic Back Pain; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Back Pain; Wounds and Injuries
Intervention: Botulinum Toxin A; Placebo
Intervention description: Subjects will receive subcutaneous Botulinum Toxin A injections into the marked painful region. The syringes will be prepared by a third party prior to the injection and the administrator of the procedure will be blinded to syringe content. This physician will be performing the injections under sterile conditions. Local anesthesia, EMLA (lignocaine/prilocaine eutectic mixture) cream, up to 4 grams, will be applied topically for local anesthesia. After 50 minutes, the cream will be cleaned off. Overlying skin will be sterilized with either betadine or alcohol solution.; Subjects will receive subcutaneous placebo injections into the marked painful region. The syringes will be prepared by a third party prior to the injection and the administrator of the procedure will be blinded to syringe content. This physician will be performing the injections under sterile conditions. Local anesthesia, EMLA (lignocaine/prilocaine eutectic mixture) cream, up to 4 grams, will be applied topically for local anesthesia. After 50 minutes, the cream will be cleaned off. Overlying skin will be sterilized with either betadine or alcohol solution.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Botulinum Toxin A; Neuropathic pain; Spinal cord injury; Pain management; Rehabilitation

Summary:

      Back pain is a common secondary condition of both acute and chronic spinal cord injury (SCI).
      Current existing treatment including both pharmacologic and non-pharmacologic are limited by
      marginal efficacy or intolerable side effects. The purpose of this study is to evaluate the
      potential of subcutaneous injections of botulinum toxin A to provide pain relief in spinal
      cord injury patients with back pain near the level of injury in the spine. Botulinum toxin A
      has been shown in both pre-clinical and clinical studies to help with nerve pain. The
      researchers propose a double blinded placebo controlled crossover study to study the effects
      of subcutaneous botulinum injections to at--level SCI back pain in patients with spinal cord
      injury.
    

Eligibility criteria:

        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.