Optimal Duration of Spinal Cord Stimulation Trial Procedure: Length and Diagnostic Accuracy

NCT ID: NCT07016581

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2026-12-31

Brief Summary

This study aims to find out the optimal duration (in days) needed for a spinal cord stimulator (SCS) trial procedure for treating chronic pain. While shorter trial periods could lower risks like infections or bleeding (especially for patients who need to stop blood thinners), patients also need sufficient time to achieve meaningful pain and function relief, and to report willingness to proceed to permanent implantation. Unfortunately, the optimal duration of an SCS trial procedure is not currently known. We aim to explore this optimal duration across a multi-center study by studying daily surveys completed across the duration of SCS trial procedures.

Detailed Description

Spinal cord stimulation (SCS) is a well-established therapy for chronic pain. However before one can proceed with SCS as a permanent therapy, they must undergo an antecedent SCS trial procedure to assess its effectiveness as a treatment for the patient's pain. The SCS trial procedure involves the percutaneous placement of leads with electrical contacts into the epidural space.

Given the infectious risks associated with an SCS trial, including those associated with significant morbidity and mortality, the typical duration of an SCS trial procedure ranges from 3 to 14 days. Additionally, given the risks for epidural hematoma formation, patients on certain anti-platelet and anti-coagulant medications require medication cessation prior to and across the SCS trial duration. In these scenarios, prolonging the withholding of these medications can place these patients at serious risks for serious embolic and/or vascular events. However, while reducing the duration an SCS trial procedure may help mitigate the risks for serious infectious and embolic and/or vascular events, patients with chronic pain conditions may typically need several days to achieve and report meaningful analgesic and functional responses and willingness to proceed with a permanent SCS implantation procedure. However, the optimal duration required for an SCS trial response has yet to be clearly established.

In this study, we aim to explore the optimal duration of the SCS trial procedure and assess how daily pain levels and patient satisfaction impact the decision to permanently implant a SCS device. The primary objective is to determine the optimal number of days required to accurately predict SCS trial procedure outcomes.

This prospective, multi-center study will enroll a target of 100 patients undergoing an SCS trial procedure (conducted in accordance to standard clinical practices per site). In addition to demographics, Patient-Reported Outcomes Measurement Information System (PROMIS) scores, SCS e-health tool recommendations, and key SCS parameters, patients will complete daily surveys to assess their analgesic and functional benefit across the duration of the SCS trial. Analyses will be performed to determine: 1) the number of days it takes to define final trial outcomes (for positive responders and not-positive responders); 2) if and how PROMIS domains correlate with days to define final trial outcomes; and 3) if and how SCS e-health tool recommendations correlate with days to define final trial outcomes.

Conditions

Chronic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Cohort

Adult patients with chronic pain undergoing an spinal cord stimulation trial procedure

Daily survey

Intervention Type: DIAGNOSTIC_TEST

All patients undergoing an spinal cord stimulation trial procedure (which will be conducted in accordance to standard clinical practices per site) will be given daily surveys to assess their analgesic and functional benefit.

Interventions

Daily survey

All patients undergoing an spinal cord stimulation trial procedure (which will be conducted in accordance to standard clinical practices per site) will be given daily surveys to assess their analgesic and functional benefit.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age >18 years old, with capacity for study consent
• Clinical evidence of a chronic pain condition amenable for treatment with spinal cord stimulation
• Chronic pain duration >12 weeks

Exclusion Criteria

• Pregnancy
• Worker's compensation status
• Previously failed spinal cord stimulation trial
• Chronic opioid use with >50 morphine milligram equivalents

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Jay Karri

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jay Karri, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Ryan D'Souza, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

University of Maryland

Baltimore, Maryland, United States

Mayo Clinic

Rochester, Minnesota, United States

Ohio State University

Columbus, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

HP-00113001

Identifier Type: -

Identifier Source: org_study_id