Abstract
Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine whether a patient should receive permanent SCS implant, its evidence base is limited. We aimed to establish the clinical utility, diagnostic accuracy, and cost-effectiveness of an SCS screening trial. A multicentre single-blind, parallel two-group randomised controlled superiority trial was undertaken at 3 centres in the United Kingdom. Patients were randomised 1:1 to either SCS screening trial strategy (TG) or no trial screening strategy (NTG). Treatment was open label, but outcome assessors were masked. The primary outcome measure was numerical rating scale (NRS) pain at 6-month follow-up. Between June 2017 and September 2018, 105 participants were enrolled and randomised (TG = 54, NTG = 51). Mean numerical rating scale pain decreased from 7.47 at baseline (before SCS implantation) to 4.28 at 6 months in TG and from 7.54 to 4.49 in NTG (mean group difference: 0.2, 95% confidence interval [CI]: -1.2 to 0.9, P = 0.89). We found no difference between TG and NTG in the proportion of pain responders or other secondary outcomes. Spinal cord stimulation screening trial had a sensitivity of 100% (95% CI: 78-100) and specificity of 8% (95% CI: 1-25). The mean incremental cost-effectiveness ratio of TG vs NTG was £78,895 per additional quality-adjusted life-year gained. In conclusion, although the SCS screening trial may have some diagnostic utility, there was no evidence that an SCS screening TG provides superior patient outcomes or is cost-effective compared to a no trial screening approach.
Highlights
Neuropathic pain is a complex and heterogeneous disorder that affects up to 8% of the adult population[3] with substantial impact on health-related quality-of-life (HRQoL).[42,43] Despite the availability of numerous pharmacological options, up to 50% of patients with neuropathic pain fail to obtain pain relief from pain relieving medication.[17]Spinal cord stimulation (SCS) is an effective treatment for severe neuropathic pain.[32]
Our results indicate that an SCS screening trial may have some diagnostic utility, it provides no patient outcome benefits compared to a no screening trial and direct to permanent SCS implantation strategy
Diagnostic block before radiofrequency denervation can be considered akin to screening trials before SCS implantation and its usefulness has been questioned
Summary
Neuropathic pain is a complex and heterogeneous disorder that affects up to 8% of the adult population[3] with substantial impact on health-related quality-of-life (HRQoL).[42,43] Despite the availability of numerous pharmacological options, up to 50% of patients with neuropathic pain fail to obtain pain relief from pain relieving medication.[17]Spinal cord stimulation (SCS) is an effective treatment for severe neuropathic pain.[32]. Neuropathic pain is a complex and heterogeneous disorder that affects up to 8% of the adult population[3] with substantial impact on health-related quality-of-life (HRQoL).[42,43] Despite the availability of numerous pharmacological options, up to 50% of patients with neuropathic pain fail to obtain pain relief from pain relieving medication.[17]. An expert clinical panel has defined a successful trial as the patient reporting $50% pain relief with
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