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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 weeks

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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