Conditions: Neuropathic Pain Chronic Pain Multiple Sclerosis
Keywords: Neuropathic pain Chronic pain Multiple sclerosis Central neuropathic pain Peripheral neuropathic pain Opioid analgesic Lidocaine
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 19
Healthy volunteers: no

Brief summary:
This study will determine whether treatment with an extended-release opioid or topical lidocaine is effective in relieving distal symmetric lower extremity burning pain associated with multiple sclerosis (MS). If treatment with topical lidocaine is efficacious, it will have important implications for understanding this chronic pain syndrome, which is widely assumed to be caused by central nervous system pathology.

Detailed description:
This study is a single-center, double-blind, 15-week, 3-period crossover clinical trial. Subjects will complete each of the following 5-week long periods (unless they withdraw from the trial): 1) placebo pills and topical lidocaine patches, 2)extended-release oxycodone pills and placebo(vehicle) patches, and 3)placebo pills and placebo patches. Sixty subjects will be randomized to one of 6 treatment sequences. It is expected that this trial will take approximately 2 years to complete.

Arms:
arm 1: 5% lidocaine patch used as intervention placebo patch used with extended release oxycodone or with placebo pills and placebo patches a randomized subjects given extended release oxycodone and placebo patches during this treatment placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group period

Interventions: intervention 1: Lidocaine patch 5% intervention 2: Extended-release oxycodone intervention 3: Placebo extended-release oxycodone pills intervention 4: Placebo lidocaine patches
Intervention descriptions: intervention 1: lidocaine 5% patch; 12 hours on, 12 hours off intervention 2: extended-release oxycodone titrating schedule intervention 3: placebo pills with titrating schedule intervention 4: used with extended release oxycodone group; used with placebo pills/placebo patches

Protocol document: