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Spinal Cord Stimulators

A Comparison of the Trial Period Versus Permanent Outcomes

Malige, Ajith MD; Sokunbi, Gbolabo MD

doi: 10.1097/BRS.0000000000002921
SURGERY
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Study Design. A retrospective chart review.

Objective. The aim of this study was to address and characterize the differences between pain relief obtained from the “trialversus permanent stimulator in the acute postoperative period (less than 6 weeks).

Summary of Background Data. After a short stimulator trial (typically less than 7 days), patients who report at least a 50% relief are set up for permanent spinal cord stimulator (SCS) placement. The literature has shown that a subset of patients develop tolerance to these stimulating therapies, often resulting in reduced efficacy of symptom relief as early as 2 years post-permanent implantation.

Methods. Between the years of 2013 and 2017, 241 patient charts who underwent a successful trial and had a subsequent permanent SCS placed by a fellowship-trained surgeon through an open incision were reviewed. For each patient, demographic information, numerical rating system (NRS) pain scores, Oswestry Disability Index (ODI) scores, and opioid medication usage were recorded and stratified by time-period (before trial, after trial and before permanent placement, and after permanent SCS placement).

Results. Of the 100 included patients, 60 were female; 60 patients had previous failed lumbar surgery (53%). Placement of trial stimulator (median = 4) decreased pain scores significantly more than permanent spinal cord stimulator did (median = 2) (P = 0.00). No significant difference was seen in ODI score difference between trial and initial scores (median = 4) and final and initial scores (median = 6) (P = 0.64). Finally, a significantly higher decrease in pain medication usage was seen after trial initiation (median = 0) versus after permanent spinal cord stimulator placement (median = 0) (P = 0.028). Twenty-two patients (22%) had reported complications, with 15 complaining of prolonged surgical site pain.

Conclusion. Discrepancies observed in symptom alleviation between percutaneous trials and permanent placement in the acute 6-week postop period can have a significant effect on patient perceived outcomes. Understanding these issues will help in providing preoperative counseling and managing postoperative expectations.

Level of Evidence: 4

This retrospective chart review looks to characterize the differences between pain relief obtained from the “trial” versus permanent stimulator in the acute post-operative period. In 100 patients, placement of trial stimulator decreased pain scores and opioid analgesic use more than the permanent stimulator did.

St. Luke's University Health Network, Bethlehem, PA.

Address correspondence and reprint requests to Ajith Malige, MD, St Luke's University Department of Orthopaedic Surgery, 801 Ostrum Street, Bethlehem, PA 18015; E-mail: ajith.malige@gmail.com

Received 8 May, 2018

Revised 6 August, 2018

Accepted 17 October, 2018

The manuscript submitted does not contain information about medical device(s)/drug (s).

No funds were received in support of this work.

No relevant financial activities outside the submitted work.

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