New data from the WHISPER randomised controlled trial (RCT) have demonstrated that patients who are given the choice to use both sub-perception and paraesthesia-based spinal cord stimulation (SCS) therapy achieve superior outcomes in comparison to patients who have only one SCS therapeutic option. The data were presented at the annual meeting of the North American Neuromodulation Society (NANS; 11–14 January, Las Vegas, USA).
The WHISPER RCT is a multicentre, prospective, cross-over, randomised, and controlled study that evaluated the long-term safety and effectiveness of sub-perception SCS therapy. Participants had been implanted with an SCS system for an average of four years at the beginning of the study and were treated with both paraesthesia and sub-perception therapy.
“The WHISPER RCT evaluated both patients who had successfully controlled their pain using SCS and those who could benefit from additional options and optimisation of their therapy,” said James North, Carolinas Pain Institute, and coordinating principal investigator of the WHISPER RCT. “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 paraesthesia-based therapy provides superior patient outcomes and affirms that SCS is a clinically valuable treatment option.”
Based on data from cohorts of 70 and 55 patients who chose sub-perception therapy for long-term follow-up, the WHISPER RCT demonstrated that:
- If patients are able to choose between the SCS therapy that provides the most effective pain relief, the number of patients whose pain was effectively controlled by SCS increased by 62%;
- 57% of patients in a study cohort preferred having the option of both sub-perception and paraesthesia-based therapy;
- Patients whose pain was managed by paraesthesia-based therapy during the randomised phase had an average reduction in baseline pain scores from 7.2 to 2.5, if they were able to choose between the SCS therapy that provided the most effective relief; and
- At 12 months, pain scores for patients who preferred sub-perception therapy decreased on average from 7.1 to 3.8 and 89% rated their condition better or a great deal better; these patients had an SCS implant for an average of five years.
The study expands on 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 experienced independent of the type of frequency (from 1kHz up to 10kHz) used in sub-perception SCS therapy when the proper target and dose are identified.
The WHISPER RCT was sponsored by Boston Scientific.