Boston Scientific declares affirmative outcomes for WHISPER RCT

On Jan 15, 2018

Boston Scientific Corporation declared optimistic outcomes from the WHISPER randomized controlled Trial.According to the data presented at the 2018 Annual meeting of the North American Neuromodulation Society in Las Vegas, patients exhibited positive outcomes who were given the choice to use both sub-perception and paresthesia-based spinal cord stimulation (SCS) as compared to patients who have only one SCS therapeutic option.

SCS works by transmitting low electric pulses varying in frquency, pulse wiff=dth and amplitude to the spinal cord to interrupt pain signals and provide pain relief. Paresthesia-based therapy provides pain relief with a light tingling sensation while sub-perception therapy works without that sensation . The WHISPER RCT assessed long term safety od=f sub- perception SCS therapy.

James North, M.D., Carolinas Pain Institute, and coordinating principal investigator of the WHISPER RCT stated “This study provides data on people who have suffered with chronic pain for years and who pose some of the biggest challenges in the long-term use of SCS. The results demonstrated that giving patients the choice to use sub-perception or paresthesia-based therapy provides superior patient outcomes and affirms that SCS is a clinically valuable treatment option.”.

Enlisting certain results of the study are as follows-

The number of subjects whose pain was effectively controlled by SCS increased by 62 percent
57 percent of patients in a study cohort preferred having the option of both sub-perception and paresthesia-based therapy
Subjects had an average reduction in baseline pain scores from 7.2 to 2.5
At 12 months, pain scores for subjects who preferred sub-perception therapy decreased on average from 7.1 to 3.8 and 89 percent

The study supplemented research from the PROCO RCT (Evaluation of Stimulation Pulse Rate on Clinical Outcomes in Patients Whose Pain is Controlled by 10 kHz Frequency) which established in de novo patients that similar pain relief and improvement in quality of life measures are achieved irrespective of the type of frequency used in sub-perception SCS therapy on ascertaining the proper target and dose.