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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Neuropathic Back Pain, Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT02736890

Run by

Icahn School of Medicine at Mount Sinai

People needed

8

Starts

2016-03-01

Expected to finish

2018-07-17

Last updated by the study team

2019-04-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Mount Sinai Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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