Prospective Evaluation of the Optimal SCS Trial Length
Ohio State University
Summary
This study aims to determine the ideal length of a spinal cord stimulation (SCS) trial period by analyzing daily pain scores, patient satisfaction, and when patients decide whether to proceed with permanent implantation. The primary goal is to identify the shortest trial duration that can reliably predict SCS success. A secondary goal is to compare SCS trial outcomes with patient-reported health measures (PROMIS domains) and recommendations from the SCS E-Health Tool to evaluate how well these tools predict treatment candidacy and outcomes.
Description
Spinal cord stimulation (SCS) is an established treatment for chronic pain and is typically preceded by a temporary trial period to evaluate treatment effectiveness before permanent implantation. Standard SCS trial durations generally range from 3 to 7 days, although some trials may be extended up to 15 days. These timeframes are largely intended to minimize the risk of epidural infection associated with prolonged epidural lead placement. However, there is limited evidence defining the optimal duration of an SCS trial, raising the possibility that many trials may be longer than clinically nece…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults aged 18 years or older who are able to provide informed consent. 2. Individuals with a clinical diagnosis of a chronic pain condition deemed appropriate for spinal cord stimulation (SCS) therapy by the treating physician. 3. Individuals with a documented duration of chronic pain greater than 12 weeks. 4. Individuals scheduled to undergo a spinal cord stimulation trial as part of routine clinical care at a participating site. Exclusion Criteria: 1. Pregnant individuals. 2. Individuals currently receiving or involved in a worker's compensation claim related to th…
Interventions
- ProcedureSpinal Cord Stimulation (SCS) Trial
This observational study will enroll approximately 42 subjects at The Ohio State University who are undergoing a spinal cord stimulation (SCS) trial as part of standard clinical care. No study-specific intervention will be assigned. Participants will be monitored to evaluate SCS trial outcomes, including pain scores, patient satisfaction, and decisions regarding permanent implantation. The sample size was selected to provide sufficient evaluable data while accounting for potential attrition and supporting descriptive and exploratory analyses.
Location
- The Ohio State UniversityColumbus, Ohio