Genetic Variants Associated With Low Back Pain and Their Response to Treatment With Duloxetine or Propranolol
Status:
Terminated
Trial end date:
2018-05-31
Target enrollment:
Participant gender:
Summary
This study is a randomized, double-blind, placebo controlled, three period crossover clinical
trial. The main purpose of this study is to determine if Chronic Low Back Pain patients
presenting with either localized or widespread painful symptoms respond differently to
treatment with Duloxetine or Propranolol, and if the effectiveness of treatment with these
drugs can determined by the presence or absence of SNPs associated with the Serotonin
receptor or Cathecol-O-MethylTransferase activity. Each treatment period will be of two weeks
duration with a 1 week washout phase between treatment periods. Following a Latin square
design, patients will be randomly assigned to one of six different treatment groups, starting
their first treatment cycle with either Duloxetine, Propranolol or Placebo and rotating
through the other treatments in the subsequent cycles. Effectiveness of treatment will be
measured by means of Pain Index as the primary outcome measure, and secondary outcome
measures will include Pressure Pain Threshold and the Pain Disability Index, Perceived Stress
Scale, Symptom Checklist -90R and the Patient's Global Impression of Change questionnaires.