High-Frequency SCS Provides Superior Clinical Outcomes

Patients with severe back and leg pain benefit more from high-frequency 10 kilohertz (HF10) spinal cord stimulation (SCS) than conventional low-frequency SCS, according to a new study.

Researchers at Carolinas Pain Institute (Winston-Salem, NC, USA) conducted a pragmatic randomized, controlled, pivotal trial in 171 patients with moderate to severe back and leg pain that persisted despite other treatments, in order to compare long-term results of HF10 therapy and traditional low-frequency SCS. The primary end point of the study was responder rate, defined as 50% or more back pain reduction from baseline at three months, with secondary end points at 12 and 24 months.

The results showed that at three months, scores for back and leg pain decreased by at least half in more than 80% of patients receiving HF10, while conventional SCS achieved similar responses in back pain for 44% of patients and in leg pain for 55%. At two years' follow-up, the HF10 group still had higher response rates: 76% versus 49% for back pain and 73% versus 49% for leg pain. About 60% of patients receiving HF10 were "very satisfied", compared to 40% with conventional SCS. The study was published in the November 2016 issue of Neurosurgery.

“The pragmatic clinical trial supports the superiority of HF10 over conventional SCS for patients with chronic, severe back and leg pain. The results are particularly impressive given the patients' long history of pain and lack of response to other treatments, including back surgery,” concluded lad author Leonardo Kapural, MD, PhD, and colleagues. “The superior and durable results demonstrated in this study are anticipated to lead to improved long-term cost effectiveness and payer acceptance, making this therapy broadly available to patients suffering from chronic pain.”

HF10 SCS therapy is delivered at a rate up to 10,000 pulses per second (10 kHz), compared to traditional SCS, which utilizes low frequency stimulation, typically 40- 60Hz. HF10 therapy also differs from traditional SCS in that it provides pain relief without paresthesia, a constant tingling sensation that is the hallmark of traditional SCS therapy. For some patients, the stimulation sensation can fluctuate and paresthesia may become uncomfortable. For others, traditional stimulation does not effectively relieve their pain.

Related Links:
Carolinas Pain Institute