Prospective Evaluation of the Optimal SCS Trial Length

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Stimulation
• Intervention / Treatment: Procedure: Spinal Cord Stimulation (SCS) Trial

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.

• Study Type: Observational
• Enrollment (Estimated): 42

Contacts and Locations

• Study Contact: Name: Nasir Hussain, MD; Phone Number: 6142933559; Email: Nasir.Hussain@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
      • Contact: Nasir Hussain, MD; Phone Number: 614-293-3559; Email: Nasir.Hussain@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

SCS Trial Participants; Participants undergoing a standard spinal cord stimulation (SCS) trial as part of routine clinical care will be observed. Daily pain scores, patient satisfaction, and decision-making regarding permanent SCS implantation will be collected during the trial period. No study-specific intervention will be administered; the study evaluates outcomes associated with the existing SCS trial process.

Procedure: Spinal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the Minimum SCS Trial Duration Predictive of Clinical Outcomes	Determining the minimum number of days required to accurately predict SCS trial outcomes.	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	15 days
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).	15 days

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Estimated): August 28, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy; Epidemiologic Study Characteristics; Clinical Studies as Topic; Spinal Cord Stimulation; Clinical Trials as Topic
• Other Study ID Numbers: STUDY20250590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The current study plan does not indicate an intention to make individual participant data (IPD) available to other researchers. Study findings will be analyzed and reported in aggregate form, and no external sharing of participant-level data is planned.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No