Prospective Evaluation of the Optimal SCS Trial Length

NCT07709351 | Not Yet Recruiting

• 1 other identifier: STUDY20250590
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Stimulation

Outcome Measures

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.

  15 days

Secondary Outcomes (2)

• Correlation Between Baseline PROMIS Domain T-Scores and Final SCS Trial Outcome

  15 days

• Correlation Between Baseline SCS E-Health Tool Candidacy Recommendation and Final SCS Trial Outcome

  15 days

Study Arms (1)

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

Interventions

Spinal Cord Stimulation (SCS) Trial PROCEDURE

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.

SCS Trial Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

Spinal Cord Stimulation; Clinical Trials as Topic

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Nasir Hussain, MD

CONTACT

6142933559; Nasir.Hussain@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): August 28, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)