Prospective Evaluation of the Optimal SCS Trial Length
ConditionSpinal Cord Stimulation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older who are able to provide informed consent.
Individuals with a clinical diagnosis of a chronic pain condition deemed appropriate for spinal cord stimulation (SCS) therapy by the treating physician.
Individuals with a documented duration of chronic pain greater than 12 weeks.
Individuals scheduled to undergo a spinal cord stimulation trial as part of routine clinical care at a participating site.
Disqualifiers
Pregnant individuals.
Individuals currently receiving or involved in a worker's compensation claim related to their pain condition.
Individuals with a history of a previously failed spinal cord stimulation (SCS) trial.
Individuals with chronic opioid use exceeding 50 morphine milligram equivalents (MME) per day.
Trial population
Certain populations will be excluded to minimize factors that may influence pain reporting, treatment response, and SCS trial outcomes. Exclusions include pregnant individuals, those involved in active worker's compensation claims, patients with prior failed SCS trials, and individuals using chronic opioids exceeding 50 MME/day. These criteria help ensure participant safety, reduce potential confounding variables, and improve the accuracy and validity of the study findings.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Spinal Cord Stimulation (SCS) Trial
Procedure/SurgeryThis 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.
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: SCS Trial Participants1 intervention
Trial outcomes
Primary outcomes
1
Determination of the Minimum SCS Trial Duration Predictive of Clinical Outcomes
Determining the minimum number of days required to accurately predict SCS trial outcomes.
Time frame
15 daysSecondary outcomes
1
Correlation Between Baseline PROMIS Domain T-Scores and Final SCS Trial Outcome
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).
Time frame
15 days2
Correlation Between Baseline SCS E-Health Tool Candidacy Recommendation and Final SCS Trial Outcome
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).
Time frame
15 daysSponsors and contacts
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Source ClinicalTrials.gov
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