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Published on: June 26, 2018
Long Term Pain Reduction and Explantation Rates of Spinal Cord Stimulation: A Systematic Review and Meta-Analysis
Matthew Saw1, Revekka Agababaeva1, Mohammad A Sabri1
1Department of Biomedical Engineering, The City College of New York, New York, NY, USA.
Background:
Spinal Cord Stimulation (SCS) is a therapeutic option for chronic pain conditions, such as persistent spinal pain syndrome, complex regional pain syndrome, painful diabetic peripheral neuropathy, and radiculopathy. The treatment typically involves a temporary trial phase before permanent implantation. Despite showing efficacy, trial phase failure and long-term SCS outcomes remain important considerations. The aim of this review was to quantify three key SCS outcomes-(1) trial phase nonresponse, (2) annual explantation rates after permanent implantation up to three years, and (3) annual <50% pain reduction rates among patients who retain their implant up to three years.
Materials And Methods:
A systematic literature review was conducted across PubMed, Embase, and Cochrane data bases to identify studies reporting on SCS outcomes. Studies were included if they reported quantitative data on at least one of the three outcomes. Data were extracted and summarized across studies. A three-level binomial generalized linear mixed model with logit link was used to calculate pooled rates across included studies. Risk of bias was assessed using the Risk of Bias 2 tool and National Institutes of Health quality assessment tools as appropriate, and certainty of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation framework.
Results:
A total of 38 studies were included in the analysis. The pooled trial phase failure rate was 16.2%. Pooled explant rates were 4.0%, 7.0%, and 11.9% at one, two, and three years respectively. Pooled rates of <50% pain reduction were 24.2%, 27.0%, and 32.8% at one, two, and three years respectively.
Conclusions:
We aggregate and analyze the durability of SCS outcomes according to a defined rubric. Outcomes were not stratified by factors that could influence response, such as waveform. 16.2% of patients assessed for SCS eligibility did not proceed past the trial phase. On average, at three years post implantation, 44.7% of patients with permanent implants had undergone explantation or reported <50% pain relief.
