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

NCT07016581 | Enrolling By Invitation

• 1 other identifier: HP-00113001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Pain

Keywords

spinal cord stimulation; spinal cord stimulation trial

Outcome Measures

Primary Outcomes (1)

• Days to Achieve Response to Spinal Cord Stimulation Trial Procedure

  minimum number of days required to accurately predict spinal cord stimulation trial outcomes (positive or negative)

  3-14 days

Study Arms (1)

Study Cohort

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

Diagnostic Test: Daily survey

Interventions

Daily survey 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.

Study Cohort

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

Adult patients with chronic pain undergoing an spinal cord stimulation trial procedure to assess for candidacy for permanent implantation of an spinal cord stimulation device.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Mayo Clinic: collaborator
• Ohio State University: collaborator
• M.D. Anderson Cancer Center: collaborator

Study Sites (4)

University of Maryland

Baltimore, Maryland, 21231, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jay Karri, MD, MPH

  University of Maryland

  PRINCIPAL INVESTIGATOR

• Ryan D'Souza, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 11, 2025
• Study Start: June 5, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

US (4)