Optimal Duration of Spinal Cord Stimulation Trial Procedure: Length and Diagnostic Accuracy

Spinal cord stimulation (SCS) is a well-established therapy for chronic pain. However before one can proceed with SCS as a permanent therapy, they must undergo an antecedent SCS trial procedure to assess its effectiveness as a treatment for the patient's pain. The SCS trial procedure involves the percutaneous placement of leads with electrical contacts into the epidural space.

Given the infectious risks associated with an SCS trial, including those associated with significant morbidity and mortality, the typical duration of an SCS trial procedure ranges from 3 to 14 days. Additionally, given the risks for epidural hematoma formation, patients on certain anti-platelet and anti-coagulant medications require medication cessation prior to and across the SCS trial duration. In these scenarios, prolonging the withholding of these medications can place these patients at serious risks for serious embolic and/or vascular events. However, while reducing the duration an SCS trial procedure may help mitigate the risks for serious infectious and embolic and/or vascular events, patients with chronic pain conditions may typically need several days to achieve and report meaningful analgesic and functional responses and willingness to proceed with a permanent SCS implantation procedure. However, the optimal duration required for an SCS trial response has yet to be clearly established.

In this study, we aim to explore the optimal duration of the SCS trial procedure and assess how daily pain levels and patient satisfaction impact the decision to permanently implant a SCS device. The primary objective is to determine the optimal number of days required to accurately predict SCS trial procedure outcomes.

This prospective, multi-center study will enroll a target of 100 patients undergoing an SCS trial procedure (conducted in accordance to standard clinical practices per site). In addition to demographics, Patient-Reported Outcomes Measurement Information System (PROMIS) scores, SCS e-health tool recommendations, and key SCS parameters, patients will complete daily surveys to assess their analgesic and functional benefit across the duration of the SCS trial. Analyses will be performed to determine: 1) the number of days it takes to define final trial outcomes (for positive responders and not-positive responders); 2) if and how PROMIS domains correlate with days to define final trial outcomes; and 3) if and how SCS e-health tool recommendations correlate with days to define final trial outcomes.