Spinal Cord Injuries Clinical Trial
Official title:
Double Blind, Randomized Placebo-controlled Clinical Study Evaluating the Efficacy of Lithium Carbonate in the Treatment of Neuropathic Pain of Patients With Spinal Cord Injury
To investigate the efficacy of lithium carbonate in the treatment of neuropathic pain of patients with spinal cord injury.
This is a randomized, placebo-controlled, double-blinded trial. Sixty spinal cord injured
subjects with neuropathic pain will be randomized into two groups. The subject in the
Treatment Group will receive lithium carbonate tablet, while the Control Group will receive
placebo tablet. Neither the subjects nor the physicians know which group the subjects are
allocated.
Each subject will receive 6 weeks of oral lithium carbonate or placebo. In the Treatment
Group, the dose will be adjusted according to the serum lithium level. While in the Control
Group, the dose will be adjusted based on the dummy serum level report.
The outcome will be assessed during visits at 1 week, 2 weeks, 6 weeks and 12 weeks, and a
phone call follow-up at 24 weeks from the start of the medication. The primary outcome
measure is the severity level of pain. The efficacy and safety will be analyzed by comparing
the results of the Treatment Group with those of the Control Group
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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