10 kHz SCS therapy for chronic pain, effects on opioid usage: Post hoc analysis of data from two prospective studies

Abstract

Chronic pain, including chronic low back and leg pain are prominent causes of disability worldwide. While patient management aims to reduce pain and improve daily function, prescription of opioids remains widespread despite significant adverse effects. This study pooled data from two large prospective trials on 10 kHz spinal cord stimulation (10 kHz SCS) in subjects with chronic low back pain and/or leg pain and performed post hoc analysis on changes in opioid dosage 12 months post 10 kHz SCS treatment. Patient-reported back and leg pain using the visual analog scale (VAS) and opioid dose (milligrams morphine equivalent/day, MME/day) were compared at 12 months post-10 kHz SCS therapy to baseline. Results showed that in the combined dataset, 39.3% of subjects were taking >90 MME dose of opioids at baseline compared to 23.0% at 12 months post-10 kHz SCS therapy (p = 0.007). The average dose of opioids in >90 MME group was significantly reduced by 46% following 10 kHz SCS therapy (p < 0.001), which was paralleled by significant pain relief (P < 0.001). In conclusion, current analysis demonstrates the benefits of 10 kHz SCS therapy and offers an evidence-based, non-pharmaceutical alternative to opioid therapy and/or an adjunctive therapy to facilitate opioid dose reduction whilst delivering significant pain relief. Healthcare providers involved in management of chronic non-cancer pain can include reduction or elimination of opioid use as part of treatment plan when contemplating 10 kHz SCS.

<p>Retrospective Assessment of Salvage to 10 kHz Spinal Cord Stimulation (SCS) in Patients Who Failed Traditional SCS Therapy: RESCUE Study</p>

“…Although randomized prospective trials of 10 kHz SCS with reduction in opioid use at the primary outcome would be welcome to substantiate our data, other published studies on 10 kHz therapy have suggested the same. 13,14 Previously, we attempted a similar therapeutic salvage tactic using the rate of 1000-1200 Hz and trialing various amplitudes in 105 consecutive patients who failed traditional, paresthesia-based SCS. 15 Although initially we found a modest therapeutic response, we could not sustain significant pain relief at one year in most patients…”

Opioid‐sparing effects of 10 kHz spinal cord stimulation: a review of clinical evidence

“…28 The combined analysis included only subjects treated with 10 kHz SCS, and baseline measures were available for 129 study subjects with low back pain and/or leg pain, while 12-month outcomes were available for 122 subjects. 38,39 In the total study population, back pain intensity decreased from 7.8 cm on a 0-10 cm VAS at baseline to 2.5 cm at 12 months, and leg pain fell from 6.3 cm at baseline to 2.0 cm at 12 months (P < 0.001 for both measures). Mean daily opioid dose in all subjects fell from 104.2 to 61.4 MME after 12 months (P < 0.001).…”

“…A recently published post‐hoc analysis used combined data from the SENZA‐RCT study and the 12‐month results of the European prospective trial first reported by Van Buyten and colleagues . The combined analysis included only subjects treated with 10 kHz SCS, and baseline measures were available for 129 study subjects with low back pain and/or leg pain, while 12‐month outcomes were available for 122 subjects . In the total study population, back pain intensity decreased from 7.8 cm on a 0–10 cm VAS at baseline to 2.5 cm at 12 months, and leg pain fell from 6.3 cm at baseline to 2.0 cm at 12 months ( P < 0.001 for both measures).…”

High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN)

“…Unlike traditional low-frequency, paresthesia-based SCS that seeks to induce paresthesias in the affected pain distribution, 10-kHz SCS therapy delivers paresthesia-independent, high-frequency stimulation by use of a unique waveform and uniform pulse width [43]. The therapy has demonstrated safety and superior effectiveness for the treatment of back and leg pain [44][45][46][47][48][49] and improved health-related quality of life [50]; 10-kHz SCS therapy has also been studied for the treatment of neuropathic limb pain, upper limb and neck pain, and pelvic pain ( [51][52][53][54] Burgher A, Kosek P, Surrett S, Rosen S, Bromberg T, Gulve A, Kansal A, Wu P, McRoberts WP, Udeshi A, et al, 10 kHz SCS for treatment of chronic pain of the upper extremities: A post-market observational study, submitted). In a prospective multicenter study treating chronic intractable pain of the limbs from peripheral polyneuropathy using 10-kHz SCS therapy, subjects reported a decrease in mean pain score from 7.9 cm (± 0.3 standard error of the mean [SEM]) at baseline (N = 26) to 2.4 cm (± 0.5 SEM) at 6 months post-implant (N = 18), and 78% of subjects were deemed responders [55].…”