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

• Status: Terminated
• Trial end date: 2018-07-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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.