![]() ![]() Individual Participant Data (IPD) Sharing Statement:ĭeidentified data will be shared in a manner TBD based on funding availability and journal requirements.īeginning 12 months and ending 3 years following article publication. Nathaniel Schuster, Assistant Profesor, University of California, San Diego The study pharmacist will place the drug capsules in identical sealed plastic bags labeled "Treatment 1" through "Treatment 3".Įffect of Gabapentin and Tizanidine on Insomnia in Chronic Pain Patients: A Randomized, Double-blind, Placebo-controlled Crossover Trial. The 3 treatments will be identically encapsulated by the study pharmacist. #CGRONIC PAIN SEVERE INSOMNIA HELP GENERATOR#Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Įach participant will have an identification number and randomization of drug sequence allocation will be performed a priori using a random number generator by the study pharmacist. #CGRONIC PAIN SEVERE INSOMNIA HELP TRIAL#Randomized, Double-bind, Placebo-controlled, Crossover Trial Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Our hypothesis is that gabapentin and tizanidine will both be more effective than placebo in alleviating insomnia in chronic pain patients but will not be different from one another. Monday-Thursday nights) will serve as a 4-day washout period between treatments. Scores on the Monday preceding the first treatment will serve as baseline and the period between treatments (i.e. ![]() Patients will also monitor their sleepiness, pain relief and overall improvement as secondary variants using the Stanford Sleepiness Scale (SSS), Visual Analog Scale (VAS), and Patient's Global Impression of Change (PGIC) questionnaires respectively. The primary outcome consists of the difference in mean AIS scores between the 3 treatments at the primary time point, which is Monday of each week (after 3 nights of drug intake). In each week, patients will receive 3-night (Friday-Sunday) trials each of placebo, gabapentin or tizanidine in a randomized, double-blind order and will monitor their insomnia using the Athens Insomnia Scale (AIS) questionnaire (adapted to fit the time frame of this trial). In this double-blind, placebo-controlled, randomized, crossover trial, gabapentin and tizanidine, two drugs which are respectively commonly used to treat neuropathic and musculoskeletal pain, will be compared to each other and to placebo in their ability to alleviate insomnia in chronic pain patients. Identifying medication that alleviates pain and insomnia simultaneously may help reduce risks associated with polypharmacy, including drug-drug interactions. Importantly, these two conditions frequently co-occur, with 50-80% of chronic pain patients reporting sleep disturbances.
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