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Burst-SCS for Chronic Pain

N/A
Recruiting
Led By Vishwanath Sankarasubramanian, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 weeks
Awards & highlights

Summary

This trial is to study a new form of spinal cord stimulation to see how effective it is in reducing chronic pain.

Who is the study for?
This trial is for men and women with chronic pain due to back issues or failed surgery, who are recommended Burst-SCS treatment. Participants must speak English and not be pregnant. They should be able to complete the study without any conditions that could interfere, as judged by the coordinator.
What is being tested?
The study tests a new therapy called Burst-SCS against a sham (fake) procedure in people with chronic pain. It involves evaluations over time and uses a device from St. Jude Medical during a randomized, double-blind crossover phase to compare effects.
What are the potential side effects?
While specific side effects aren't listed here, spinal cord stimulation can generally cause discomfort at the site of implantation, unwanted changes in stimulation feeling over time, or nerve damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Visual Analog Scale (VAS) score
Secondary study objectives
Change in Brief Pain Inventory-Short Form (BPI-SF) score
Change in General Pain Disability Index (PDI) score
Pain
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sham SCS/Burst-SCSExperimental Treatment2 Interventions
First, participants will receive sham (no) SCS. Study evaluations will be completed prior to and after this sham. Then, participants will have their stimulation adjusted to receive clinically-effective Burst-SCS per their standard of care. Study evaluations will be completed prior to and after stimulation.
Group II: Burst-SCS/sham SCSExperimental Treatment2 Interventions
First, participants will receive clinically-effective Burst-SCS per their standard of care. Study evaluations will be completed prior to and after stimulation. Then, participants will have their stimulation adjusted to receive sham (no) SCS. Study evaluations will be completed prior to and after this sham.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,833 Previous Clinical Trials
6,423,108 Total Patients Enrolled
32 Trials studying Chronic Pain
3,888 Patients Enrolled for Chronic Pain
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,491 Total Patients Enrolled
26 Trials studying Chronic Pain
22,975 Patients Enrolled for Chronic Pain
Vishwanath Sankarasubramanian, PhDPrincipal InvestigatorUniversity of Michigan

Media Library

Burst-SCS Clinical Trial Eligibility Overview. Trial Name: NCT03718325 — N/A
Chronic Pain Research Study Groups: Burst-SCS/sham SCS, Sham SCS/Burst-SCS
Chronic Pain Clinical Trial 2023: Burst-SCS Highlights & Side Effects. Trial Name: NCT03718325 — N/A
Burst-SCS 2023 Treatment Timeline for Medical Study. Trial Name: NCT03718325 — N/A
~5 spots leftby Jun 2026
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