Spasticity in Spinal Cord Injured Persons Clinical Trial
Official title:
Randomized Double Blind Cross Over Study Assessing the Effect of Cannabiniods on Spasticity in Spinal Cord Injured Persons :A Pilot Study
Objectives: To determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in
people with spinal cord injury (SCI).
Methods: Twelve subjects were enrolled in this double-blind, placebo-controlled, crossover
study. They received either nabilone or placebo during the first four-week period (0.5mg OD
with option to increase to 0.5mg BID), then outcome measures were assessed. After a two-week
washout, subjects were crossed-over to the opposite arm.
The primary outcome was the Ashworth scale for spasticity in the most involved muscle group,
chosen by the subject and clinician. The secondary outcomes included Spasm Frequency Scale,
Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle
groups of each side of the body, and the Clinician's and Subject's Global Impression of
Change .
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