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Spinal Cord Stimulation

Spinal Cord Stimulation for Chronic Pain

N/A
Recruiting
Led By David Darrow, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
22 years of age or older
Baseline pain rating (NRS/VAS) >=6
Must not have
Scheduled for permanent implantation only without trial
Individuals who are unable to consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how different types of electrical stimulation can reduce chronic back and leg pain. Participants report daily pain scores to identify the best setting for them.

Who is the study for?
This trial is for English-speaking adults aged 22 or older with chronic back pain or radiculopathy, who are scheduled to undergo spinal cord stimulation and have a baseline pain rating of 6 or higher. It excludes those getting permanent implants without a trial, people with pacemakers/neurostimulators, pregnant individuals, those unable to consent, employees/students of the principal investigator (PI), prisoners, and anyone unable to read/use a smartphone.
What is being tested?
The study tests different patterns of spinal cord stimulation (tonic, burst, multistim) in patients with chronic pain. Participants will be blinded to the type they receive and report daily pain scores over four months. The most effective setting for reducing pain will be identified using Thompson sampling and recommended for future use.
What are the potential side effects?
While not explicitly listed in the provided information, common side effects from spinal cord stimulation can include discomfort at the site of implantation, tingling sensations from the electrical impulses, bleeding/infection risk post-surgery and potential equipment malfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 22 years old or older.
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My pain level is 6 or higher on a scale of 0-10.
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I am scheduled for a spinal cord stimulation procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for a permanent implant without a trial period.
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I am unable to give consent by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility
Secondary study objectives
Acceptability of procedure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental groupExperimental Treatment1 Intervention
Prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,435 Previous Clinical Trials
1,621,648 Total Patients Enrolled
9 Trials studying Chronic Pain
3,133 Patients Enrolled for Chronic Pain
David Darrow, MDPrincipal InvestigatorUniversity of Minnesota
5 Previous Clinical Trials
210 Total Patients Enrolled

Media Library

Various Stimulation Patterns (Spinal Cord Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05741788 — N/A
Chronic Pain Research Study Groups: Experimental group
Chronic Pain Clinical Trial 2023: Various Stimulation Patterns Highlights & Side Effects. Trial Name: NCT05741788 — N/A
Various Stimulation Patterns (Spinal Cord Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05741788 — N/A
~6 spots leftby Oct 2025
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