Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain

Abstract

HF10 therapy promises to substantially impact the management of back and leg pain with broad applicability to patients, physicians, and payers.

Effects of Rate on Analgesia in Kilohertz Frequency Spinal Cord Stimulation: Results of the PROCO Randomized Controlled Trial

“…These reports also suggest equivalent pain relief is achievable with 10 kHz and lower rates (either 1 or 2 kHz), but using in‐clinic pain scores they observed 70–80% improvement from baseline. These findings are also consistent with the SENZA RCT 1 which assessed back pain VAS in the clinic and reported 62.8% mean VAS change from baseline, while also assessing back pain (at rest) via paper diary and reported 56.2% reduction 50. Similarly, the SENZA RCT responder rate based on in‐clinic assessment of pain (78.4%) was greater than the responder rate based on paper diary (65.7%) 50.…”

“…SENZA did report a larger NRS decrease (∼70%) 1 than the ED‐NRS decrease (∼50%) reported by PROCO, but this difference is likely explained by the different methods used in each study to measure pain (see Discussion section Direct comparison of pain assessment using e‐diary with pain assessment in the clinic ). Also, patients and clinicians in the SENZA RCT knew which treatment was being applied, and multiple studies have shown that positive and negative patient expectations can significantly impact pain, sleep, depression, and physical function 53, 54, 55, 56.…”

“…Thus, a fundamental understanding of the mechanism(s) of action by which sub‐perception SCS acts is still lacking. Further, while the sub‐perception modality has been shown to be effective at very high rates 1, the sensitivity of the modality to the rate parameter is not clear. Understanding the sensitivities of clinical effects to parameters can potentially contribute information that is valuable in the search for mechanistic understanding.…”

Long-term quality of life improvement for chronic intractable back and leg pain patients using spinal cord stimulation: 12-month results from the SENZA-RCT

“…Detailed methods, including subject demographics and subject flow diagram, are described elsewhere [29]. Briefly, a pair of percutaneous leads was placed in the dorsal epidural space along the radiographic midline of the spinal column and stimulation was trialed for up to 14 days.…”

Dorsal root ganglion stimulation approval by the Food and Drug Administration: advice on evolving the process

“…Device-related FDA approvals have been performed largely by the acquisition of level 1 data, regarded as the most robust and scientifically valid evidence available [4][5][6]. Understandably, it is the foremost position of the FDA to approve products that have proven efficacy and safety and to protect the public while allowing access to the best care possible and innovation.…”