Section 15: WHISPER STUDY Flashcards
Who is the main doctor on the Whisper study?
Dr. James North
What kind of study is the whisper study?
A prospective, multicenter, randomized control trial with a crossover design.
What is the goal of the Whisper study?
To see if patients who had previously been implanted due to low back pain and/or leg pain would have better pain relief with a subperception SCS at frequencies of <1.2 khz
What was one important thing the patients had to do before recording their baseline pain score for the whisper study?
Turn their stimulator off for 7 days!!
What two types of stimulation were tested in the whisper trial?
Supra-perception (paresthesia based) and sub-perception (no sensation)
What product launched just before the results of this study came out?
Spectra wavewriter
According the whisper study, if patients are able to choose between subperception and Supra-perception, the number of subjects whose pain was effectively controlled by SCS increased by what percentage?
62%
What percentage of patients preferred having both sub-perception and paresthesia based therapy as options?
57%
By how many points did the patients NRS improve by from baseline to whatever was the ‘best option’ (Supra or sub) ?
7.0 to a 2.5…. an improvement of 4.5 points
What were the responder rates for Supra Only, Sub Only, and Best Option STIMS?
Supra: 27%
Sub: 35%
Best: 47%
How many people were enrolled in the study and how many centers?
229 enrolled but 140 randomized.
22 US centers
True or false: subperception demonstrated superior to Supra-perception
FALSE. it was non inferior
For those who preferred subperception, what did their baseline NRS score go to at 12 months post op?
7.3 to a 4.0
True or false: the Whisper study was blinded
FALSE
