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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
19
lidocaine 5% patch; 12 hours on, 12 hours off
extended-release oxycodone titrating schedule
placebo pills with titrating schedule
University of Rochester Medical Center
Rochester, New York, United States
Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period
subject identifies daily pain rating during final week of each treatment period using a numeric rating scale
Time frame: Daily
Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)
subject is questioned regarding any adverse events that have occured since the last contact; also subject can document any issues on daily pain rating diaries
Time frame: rating of adverse events occur at each visit
Safety (i.e., Number of Serious Adverse Events)
Subject is asked about any adverse events that may have occurred since last contact; also subject can document any adverse events on daily pain diary scales
Time frame: rating and review of any adverse events occurs at each visit
Brief Pain Inventory Interference Items
subject completes the brief pain questionaire
Time frame: occurs Visit 1, 3,4,5
Daily Diary Sleep Interference Ratings
Subject identifies degree of sleep interference on a daily basis
Time frame: daily
Beck Depression Inventory
Subject completes Beck questionaire
Time frame: occurs at Visit 1, 3, 4 and 5
Short-form Health Survey 36 (SF-36)
Subject completes short form health survey 36 questionaire
Time frame: Occurs at Visit 1, 3, 4 and 5
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used with extended release oxycodone group; used with placebo pills/placebo patches
Short-Form McGill Pain Questionnaire
Subject completes short form McGill Pain questionaire
Time frame: Occurs Visit 1, 3, 4 and 5
Patient Global Impression of Change Scale
Subject completes patient global impression questionaire of change scale
Time frame: Occurs Visit 3, 4, 5
Kurtzke Expanded Disability Status Scale
Subject completes questionaire on functional status
Time frame: Occurs at Visit 1