Pain Relief and Safety Outcomes with Cervical 10 kHz Spinal Cord Stimulation: Systematic Literature Review and Meta-analysis

Abstract

Background: Chronic pain in head, neck, shoulders and upper limbs is debilitating, and patients usually rely on pain medications or surgery to manage their symptoms. However, given the current opioid epidemic, non-pharmacological interventions that reduce pain, such as spinal cord stimulation (SCS), are needed. The purpose of this study was to review the evidence on paresthesia-free 10 kHz SCS therapy for neck and upper extremity pain.Methods: Systematic literature search was performed for studies reporting outcomes for cervical 10 kHz SCS using date limits from May 2008 to November 2020. The study results were analyzed and described qualitatively. Additionally, when feasible, meta-analyses of the outcome data, with 95% confidence intervals (CIs), were conducted using both the fixed-effects (FE) and random-effects (RE) models. Results: A total of 15 studies were eligible for inclusion. The proportion of patients who achieved C 50% pain reduction was 83% (95% CI 77-89%) in both the FE and RE models. The proportion of patients who reduced/eliminated their opioid consumption was 39% (95% CI 31-46%) in the FE model and 39% (95% CI 31-48%) in the RE model. Pain or discomfort with the implant, lead migration, and infections were potential risks following cervical SCS. Explant rate was 0.1 (95% CI 0.0-0.2) events per 100 person-months, and no patients in the included studies experienced a neurological complication or paresthesia. Conclusion: Findings suggest 10 kHz SCS is a promising, safe, minimally invasive alternative for managing chronic upper limb and neck pain.

Ten kHz spinal cord stimulation for the treatment of chronic peripheral polyneuropathy: 12‐Month results from prospective open‐label pilot study

“…A large randomized controlled trial (RCT) demonstrated its safety and superior effectiveness for the treatment of back and leg pain over T-SCS 16,17 along with improved quality of life and opioid reduction. 15,[18][19][20][21][22][23] The results were confirmed by other retrospective and prospective studies in patients with back and leg pain. 22,[24][25][26][27][28][29][30] Prospective and retrospective studies have also demonstrated promising outcomes for the treatment of migraine headaches, 31 complex regional pain syndrome (CRPS), 32 chronic widespread pain, 33 pelvic pain, 34 upper and lower limb neuropathic pain, 35,36 and neck pain.…”

Role of patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain: a comprehensive narrative review

“…Most reviews considered all types of implants, with two reviews considering only percutaneous implants27 30 and five not specifying the type of implant. Nearly two-thirds considered mixed or all types of stimulation, with eight considering only CS, two on HFS14 71 and one on burst stimulation (BS) 18. The most common comparator was conventional medical management (CMM), although some compared different SCS types, with one comparing BS, CS, and HFS,35 and two others comparing BS and CS 18 32.…”

Stimulating Results Signal a New Treatment Option for People Living With Painful Diabetic Neuropathy

“…15 The results reported are equal to, if not better than, pain relief with 10-kHz SCS recorded in other pain types like back pain and upper limb and neck pain. 28,[37][38][39][40] At 3 months after implantation, 79% of patients in the intention-to-treat population achieved ≥50% pain relief plus no worsening of baseline neurological deficits, compared with only 5% of CMM patients (P < .001; study primary end point). 15 In terms of pain relief alone at 3 months, 78% of patients reported pain scores of 3 cm or less on the VAS (P < .001 vs 5% with CMM).…”