Spinal Cord Stimulation
Conditions
Brief 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.
Detailed 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 necessary (1). Reducing the duration of SCS trials could provide several clinical benefits. Shorter trials may decrease the risk of infection, reduce the need for prophylactic antibiotic exposure, and minimize the length of time patients must interrupt antiplatelet or anticoagulant therapy when applicable. Determining the shortest trial duration that reliably predicts treatment success could improve patient safety while streamlining clinical care. This study aims to identify the optimal duration of the SCS trial by evaluating daily pain scores, patient satisfaction, and the timing of patients' decisions to proceed with permanent SCS implantation. The primary objective is to determine the minimum number of trial days required to accurately predict SCS trial success. The secondary objective is to evaluate the association between SCS trial outcomes and patient-reported outcome measures, including PROMIS domain scores and candidacy recommendations generated by the SCS E-Health Tool, to assess their ability to predict SCS candidacy and treatment outcomes.
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.
Sponsors
Ohio State University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 their pain condition. 3. Individuals with a history of a previously failed spinal cord stimulation (SCS) trial. 4. Individuals with chronic opioid use exceeding 50 morphine milligram equivalents (MME) per day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of the Minimum SCS Trial Duration Predictive of Clinical Outcomes | 15 days | Determining the minimum number of days required to accurately predict SCS trial outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Baseline PROMIS Domain T-Scores and Final SCS Trial Outcome | 15 days | Assessment of the correlation between baseline Patient-Reported Outcomes Measurement Information System (PROMIS) domain T-scores (Pain Interference, Physical Function, Depression, Anxiety, and Sleep Disturbance) and the final spinal cord stimulation (SCS) trial outcome (successful vs. unsuccessful trial). |
| Correlation Between Baseline SCS E-Health Tool Candidacy Recommendation and Final SCS Trial Outcome | 15 days | Assessment of the correlation between the baseline SCS E-Health Tool candidacy recommendation and the final spinal cord stimulation (SCS) trial outcome (successful vs. unsuccessful trial). |
Countries
United States
Contacts
CONTACTNasir Hussain, MD
Outcome results
None listed