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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
250 mg/tablet, 6 weeks course of oral administration
placebo tablet, 6 week course of oral administration
Xi'an Jiaotong University Second Affiliated Hospital
Xi’an, Shanxi, China
China Rehabilitation Research Center
Beijing, China
Change from Baseline in Numeric Rating Scale (NRS) at 24 weeks
pain severity level
Time frame: D0, Wk 1, 2, 6, 12, and 24
Change in Multidimensional Pain Inventory Life Interference Subscale (MPI-LIS)
Time frame: D0, Wk 1, 2, 6, 12 and 24
Change in Short-Form 36 single question
Time frame: D0, Wk 1, 2, 6, 12, and 24
Change in Sleep Interference Assessment score
Time frame: D0, Wk 1, 2, 6, 12 and 24
Change in weekly number of days with pain attack
Time frame: D0, Wk 1, 2, 6, 12 and 24
Change in the Patient Global Impression of Change (PGIC)
Time frame: Wk 1, 2, 6, and 12
Change in Patient Health Questionnaire (PHQ-9)
Time frame: D0, Wk 1, 2, 6 and 12
Change in sensory score, motor score and ASIA impairment (AIS) scale
Time frame: D0, Wk 6 and 12
Change in Modified Ashworth Scale
Time frame: D0, Wk 6 and 12
Magnetic resonance diffusion tensor imaging (optional)
Time frame: D0, Wk 6 and 12
Electrophysiology (optional)
Time frame: D0, Wk 6 and 12
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