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

ID#: NCT02736890

Age: 18 - 80 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: March 01, 2016

End Date: June 01, 2018

Contact Information:
Ajax Yang, MD, MPT
Thomas Bryce, MD

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.


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.