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: The SENZA-RCT Randomized Controlled Trial.

BACKGROUND: Current treatments for chronic pain have limited effectiveness and commonly known side effects. Given the prevalence and burden of intractable pain, additional therapeutic approaches are desired. Spinal cord stimulation (SCS) delivered at 10 kHz (as in HF10 therapy) may provide pain relief without the paresthesias typical of traditional low-frequency SCS. The objective of this randomized, parallel-arm, noninferiority study was to compare long-term safety and efficacy of SCS therapies in patients with back and leg pain. METHODS: A total of 198 subjects with both back and leg pain were randomized in a 1:1 ratio to a treatment group across 10 comprehensive pain treatment centers. Of these, 171 passed a temporary trial and were implanted with an SCS system. Responders (the primary outcome) were defined as having 50% or greater back pain reduction with no stimulation-related neurological deficit. RESULTS: At 3 months, 84.5% of implanted HF10 therapy subjects were responders for back pain and 83.1% for leg pain, and 43.8% of traditional SCS subjects were responders for back pain and 55.5% for leg pain (P < 0.001 for both back and leg pain comparisons). The relative ratio for responders was 1.9 (95% CI, 1.4 to 2.5) for back pain and 1.5 (95% CI, 1.2 to 1.9) for leg pain. The superiority of HF10 therapy over traditional SCS for leg and back pain was sustained through 12 months (P < 0.001). HF10 therapy subjects did not experience paresthesias. CONCLUSION: HF10 therapy promises to substantially impact the management of back and leg pain with broad applicability to patients, physicians, and payers.

A double-blind, randomized, prospective study of epidural steroid injection vs. the mild® procedure in patients with symptomatic lumbar spinal stenosis.

BACKGROUND: Epidural steroid injections (ESIs) are commonly used to treat low back pain, including symptomatic lumbar spinal stenosis (LSS). Reports on LSS treatment with ESIs have not differentiated between neurogenic claudication, which is believed to result from nerve root compression, and lumbar radicular pain, thought to be caused by inflammation. While there is overlap between these groups, the clinical relevance of ESI treatment cannot be generalized between these 2 distinct diseases with completely different pathophysiological causes. METHODS: This was a double-blind, randomized, prospective study of ESI vs. the mild procedure in patients with symptomatic LSS, conducted at a single pain management center. Patient reported outcome measures included Visual Analog Scale, Oswestry Disability Index, and Zurich Claudication Questionnaire (ZCQ) patient satisfaction. RESULTS: Thirty-eight patients were randomized into 2 treatment groups, 21 in mild and 17 in ESI. At 6- and 12-week follow-up, patients treated with mild reported significantly greater pain decrease over time (P < 0.0001), and significantly greater functional mobility improvement over time (P < 0.0018) than ESI patients. At week 6, mild ZCQ patient satisfaction score of 2.2 indicated a higher level of satisfaction than for ESI with a score of 2.8. In addition, 12-week ZCQ satisfaction score was 1.8, demonstrating sustained near-term satisfaction in the mild group. No major mild or ESI device or procedure-related complications were reported. CONCLUSIONS: This study demonstrated that in LSS patients suffering with neurogenic claudication, mild provides statistically significantly better pain reduction and improved functional mobility vs. treatment with ESI.

The Impact of Age on the Outcomes of Minimally Invasive Lumbar Decompression for Lumbar Spinal Stenosis.

BACKGROUND AND PURPOSE: Minimally invasive lumbar decompression (mild ®) is an effective long-term therapy for patients with symptomatic lumbar spinal stenosis (LSS) resulting primarily from hypertrophic ligamentum flavum (HLF). Most subjects in clinical studies of the mild procedure have been older adults (age≥65). While the incidence of LSS increases with age, a substantial number of adults (age<65) also suffer from neurogenic claudication secondary to HLF. In this report, outcomes of mild were compared between adults and older adults. PATIENTS AND METHODS: All prospective studies of the mild procedure with a 1-year follow-up completed since the beginning of 2012 that allowed the inclusion of adult patients of all ages were reviewed. Outcomes of visual analog scale (VAS), Oswestry Disability Index (ODI), Pain Disability Index (PDI), Roland Morris Low Back Pain and Disability Questionnaire (RMQ), standing time and walking distance were compared for adults and older adults. RESULTS: Four studies met the inclusion criteria, resulting in an analysis of 49 adults and 160 older adults. Patients in both age groups experienced significant mean improvements in all but one outcome measure at 6- and 12-month follow-up. Differences between the two age groups in all scores at 6 and 12 months were not statistically significant. CONCLUSION: Analysis of the four studies indicated that symptom improvements for adults and older adults were significant from baseline, and no statistically significant difference was observed between the two age groups. These results illustrate that mild can be an effective treatment for LSS due primarily to HLF, regardless of the adult patient age.