Results of a randomized, controlled (RCT) study 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) were published recently 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, Stimwave Technologies Inc announces in a media release.
In the study, which took place at seven centers throughout the United States, all subjects received a wireless Freedom spinal cord stimulator system and were randomized to either 10 kHz or 1500 Hz and lower, mixed signal. They were followed for 6 months after an initial 1-month trial.
“Patients in both groups experienced significant reductions in pain scores for both low back and leg pain 7 months after implantation,” says Robert Bolash, MD, the primary investigator for the study at the Cleveland Clinic.
At the 6-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 (PPain Medicine journal, 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,” says Laura Perryman, co-founder and CEO of Stimwave, in the release.
“With the FDA clearance of 10,000 Hz, Stimwave US 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.”
[Source(s): Stimwave, Business Wire]