Stimwave has announced completion of patient enrolment and preliminary results of the first-of-its-kind Tsunami study. The Tsunami placebo-controlled double-blind randomised clinical trial (RCT) is the first ever placebo-controlled double-blind RCT in the chronic pain relief neuromodulation industry. This study is also the first study evaluating the delivery of a high frequency waveform acting on sensory fibres at the dorsal root ganglion (DRG) and dorsal horn portions of the dorsal column.
“This study, when complete, will be a monumental step-up for evidence-driven medicine in the rapidly growing field of neuromodulation,” said Andrea Trescot, the chief medical officer of Stimwave and former president of the American Society of Interventional Pain Physicians (ASIPP). “Every other industry is expected to show efficacy through sham and placebo-controlled studies; the Tsunami study is growing the evidence that single stage, wireless neurostimulators can offer more options to more pain patients.”
The Tsunami study has now completed enrolment with 50 chronic low back pain subjects. Subjects underwent a small procedure with a one-stage implant, and the electrodes are placed using a novel technique at the T9 level and the exiting nerve root. Patients were randomised to either active therapy or sham and implanted without general anaesthesia. Patients in the sham arm did not receive any therapeutic stimulation for at least one month, and were never active at any point while blinded. If patients were reporting less than 50% pain reduction, they were unblinded and sham patients were crossed over to the treatment arm.
The preliminary results with 38 subjects show a very positive outlook for this unique therapy. Sixty-three per cent of active subjects were successful by reducing pain greater than 50%. Comparatively, only 16% of the sham subjects reported 50% pain reduction thus demonstrating a statistically significant (p=0.007) in favour of the active therapy. At the time of this report, all sham patients were unblinded and now 77% of all patients are reporting greater than 50% pain reduction.
“This double-blind RCT study utilising subthreshold therapy has shown that wireless high frequency DRG stimulation is statistically superior to sham,” said Bart Billet. “The study shows that our transgrade approach was safe and effective, and that stimulating the DRG at T9 was effective in providing back and leg pain relief. The patients are doing well and are very pleased with their pain relief and are extremely satisfied with the positive impact the pain relief has on their daily life.”
The Freedom SCS (spinal cord stimulation) system is the world’s first wireless, fully-programmable SCS neuromodulation device providing a life-changing technological breakthrough for the more than 90 million people in the USA who endure daily chronic back and leg pain. The Freedom stimulators are designed to be a less-invasive alternative to treat patients with chronic pain, typically that would otherwise warrant surgery to place paddles leads or large IPGs, which have been reported to have substantial complications in at least a third of all patients. The Freedom SCS system is FDA cleared and commercially available in the USA, Europe, and Australia.