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.
Highlights
Chronic pain, defined as pain that remains beyond normal healing time, is a debilitating group of conditions and a prominent cause of disability worldwide[1]
In SENZA-RCT, 89 subjects were successfully included through 12 months and in SENZA-EU, 68 subjects were included through 12 months
Due to minor differences in inclusion criteria between SENZA-EU and SENZA-RCT studies, such as requirement of back pain with visual analog scale (VAS) score ≥5 cm regardless of leg pain in the former study and requirement of both back and leg pain VAS scores ≥5 cm in the latter study, the baseline average back pain VAS scorewas 1 cm higher than SENZA-EU study (8.4 ± 0.2 cm compared with 7.5 ± 0.1 cm), while the average leg pain score was 2 cm lower (5.1 ± 0.4 cm compared with 7.1 ± 0.2 cm)
Summary
Chronic pain, defined as pain that remains beyond normal healing time, is a debilitating group of conditions and a prominent cause of disability worldwide[1]. Opioid use for chronic pain conditions like CLBP can cause tolerance, hyperalgesia, misuse, abuse and diversion[24,25,26,27]. The challenge for patients and prescribers is for patients taking ≥90 MME/day, the CDC recommends other approaches to pain management and a taper and discontinue approach for the opioid[29]. A minimally invasive alternative to opioid therapy is spinal cord stimulation (SCS), a type of neuromodulation typically used to treat chronic intractable neuropathic pain conditions like failed back surgery syndrome (FBSS)[31]. Some patients report paresthesia as an unpleasant sensation[34] and the perceived intensity of paresthesia can increase with body movement[35] Another challenge of previous devices and new iterations of these devices is providing durable pain relief for back and leg pain. Multiple studies demonstrated that approximately 50% of the patients achieve ≥50% pain relief with traditional SCS and even in the patients who respond initially, therapy effectiveness was found to diminish with time[36,37,38,39,40,41,42,43,44]
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