Efficacy and Safety of 10 kHz Spinal Cord Stimulation for the Treatment of Chronic Pain: A Systematic Review and Narrative Synthesis of Real-World Retrospective Studies.

Ganesan Baranidharan,Abdul-Ghaaliq Lalkhen,Deborah Edgar,Tracey Crowther,Girish Vajramani,Ann-Katrin Fritz,Beatrice Bretherton

doi:10.3390/biomedicines9020180

Abstract

10 kHz spinal cord stimulation (SCS) is increasingly utilized globally to treat chronic pain syndromes. Real-world evidence complementing randomized controlled trials supporting its use, has accumulated over the last decade. This systematic review aims to summarize the retrospective literature with reference to the efficacy and safety of 10 kHz SCS. We performed a systematic literature search of PubMed between 1 January 2009 and 21 August 2020 for English-language retrospective studies of ≥3 human subjects implanted with a Senza® 10 kHz SCS system and followed-up for ≥3 months. Two independent reviewers screened titles/abstracts of 327 studies and 46 full-text manuscripts. In total, 16 articles were eligible for inclusion; 15 reported effectiveness outcomes and 11 presented safety outcomes. Follow-up duration ranged from 6–34 months. Mean pain relief was >50% in most studies, regardless of follow-up duration. Responder rates ranged from 67–100% at ≤12 months follow-up, and from 46–76% thereafter. 32–71% of patients decreased opioid or nonopioid analgesia intake. Complication incidence rates were consistent with other published SCS literature. Findings suggest 10 kHz SCS provides safe and durable pain relief in pragmatic populations of chronic pain patients. Furthermore, it may decrease opioid requirements, highlighting the key role 10 kHz SCS can play in the medium-term management of chronic pain.

Highlights

Chronic pain is reported to affect around 20% of adults [1,2] and is a significant cause of suffering and disability [3]
A total of 373 unique articles were identified from the initial PubMed query: 327 articles were screened by title and/or abstract only, and 46 articles were screened by full-text manuscript review
The full-texts of the 16 remaining articles were subsequently reviewed for the presence of relevant effectiveness and/or safety outcomes

Summary

Introduction

Chronic pain is reported to affect around 20% of adults [1,2] and is a significant cause of suffering and disability [3]. A multidisciplinary approach to chronic pain treatment may include pharmacotherapy, psychological and physical therapy, neuromodulation, nerve ablation and therapeutic injections, and nerve stimulation [11]. Increasing reliance on opioids to treat chronic pain has become problematic in developed countries [13,14]. While short-term opiate use appears to be beneficial in chronic pain [15], long-term use has little supportive evidence, carries the risk of addiction [16,17,18,19] and is associated with common adverse effects such as constipation, nausea, and drowsiness. Less-known effects have been reported, including opioid-induced

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Discussion

Conclusion