Pain Clinical Trial
Official title:
Can Pregabalin Prevent the Development of Neuropathic Pain Following Spinal Cord Injury? A Double-Blind, Randomized, Placebo Controlled Trial.
This research study will test to see if people who receive pregabalin after their spinal cord injury will develop less nerve damage pain than people who do not receive it.
Pregabalin is one of the few agents that have demonstrated effectiveness in the treatment of
central NeP in SCI. Research is now proving that it is possible to prevent the development
of pain in certain conditions. Pregabalin has been proven effective in this area with post
surgical pain. Therefore, after traumatic SCI there may be a small window of time where we
could prevent the development of NeP by administering an agent like Pregabalin.
Objective: To test the hypothesis that pregabalin is an effective treatment in preventing
post-spinal cord injury neuropathic pain.
Design: double-blind, placebo controlled, randomized, trial Setting: Spinal cord injury
program, neurosurgery and tertiary care rehabilitation center Subjects: 30 patients with
acute traumatic spinal cord injury Method: Pregabalin will be offered to patients with acute
traumatic spinal cord injury pain in a double blind crossover, placebo control design.
Main Outcome Measures: The primary outcome measures will be the development of Neuropathic
Pain and intensity of pain Secondary outcome measures will be Ashworth's Scale for
spasticity and ASIA motor and Sensory Scores.
Results: To be determined. Conclusion: To be determined.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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