Stimwave has announced publication of the results of the first ever randomised, controlled trial (RCT) comparing wireless high-frequency (HF: 10 kHz) spinal cord stimulation (SCS) with wireless lower-frequencies of multiple mixed waveforms (LF: 50-1500 Hz tonic, burst, high density) for the treatment of failed back surgery syndrome (FBSS) in Pain Medicine. The direct to permanent study results showed true paradigm shifting outcomes for the battery-free, opioid free, pain management system, with subjects receiving an average of 77% back pain relief with 84% being in remission long term.
All subjects received a wireless Freedom spinal cord stimulator system and were randomised to either 10 kHz or 1500 Hz and lower, mixed signal. They were followed for six months after an initial one-month trial. The study took place at seven centres throughout the USA.
“Patients in both groups experienced significant reductions in pain scores for both low back and leg pain seven months after implantation,” said Robert Bolash, the primary investigator for the study at the Cleveland Clinic in Cleveland, USA.
At the six-month primary end point, the mean back pain VAS reduction for the HF arm was 77% and 64% for the LF arm, matching the range of wired HF products even at 1500 Hz mixed waveforms. Leg pain–associated mean VAS reductions were 76% for HF and 64% for LF. The VAS reductions from baseline were statistically significant (P<0.0001) for both arms.
“The study results provide evidence that 10 kHz wireless SCS is an effective and safe treatment option,” said Bolash. “The findings of this study show that wireless 10 kHz SCS provides pain relief while eliminating an implanted battery. This technology may have the potential to reduce the overall cost of treating our patients with chronic pain.”
“Stimwave was the first to introduce a true multi-waveform platform worldwide, with the iOS programming capabilities of WaveMaster. We are honoured to have this Level I RCT data published in Pain Medicine, demonstrating the long-term positive outcomes for wireless SCS to be shown to be tremendously effective, at 77% pain relief, all in a convenient minimally invasive package,” said Laura Perryman, co-founder and CEO of Stimwave. “With the FDA clearance of 10,000 Hz, Stimwave USA patients now have an additional waveform to ensure maximum amount of ability to modify their programming to fit their individual pain management needs and decrease the effects of plasticity.”
In summary, of the 72 subjects that completed the six-month endpoint, the average reduction in back pain was 77% for high frequency stimulation, compared to 66% for low frequency. In accordance, the average reduction in leg pain was 76% and 64% for high and low frequency, respectively. Further, the percentage of subjects in remission from chronic pain (VAS <25mm) was 84% for high frequency versus 47% in the low frequency cohort. On average, subject’s level of disability improved by 43% with high frequency and 42% with low frequency stimulation, while median satisfaction improved to 6 out of 7 (on the Patient’s Global Impression of Change instrument).
Stimwave Freedom Stimulators are implanted in an outpatient procedure with no need for general anaesthesia, a large surgical incision or a bulky internal battery. These products are expected to significantly reduce the lifetime cost of care for chronic pain patients and offer a safe, viable and effective alternative to opioids. The Freedom SCS system is currently available in the USA and worldwide, with frequencies up to 10,000 Hz.