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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Visual Analog Scale (VAS) score

Secondary outcome measures

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,807 Previous Clinical Trials

6,383,356 Total Patients Enrolled

32 Trials studying Chronic Pain

3,866 Patients Enrolled for Chronic Pain

National Institutes of Health (NIH)NIH

2,714 Previous Clinical Trials

7,511,313 Total Patients Enrolled

25 Trials studying Chronic Pain

22,828 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are involved in this investigation?

"Affirmative. Clinicaltrials.gov hosts data demonstrating that this medical study, which was first introduced on March 12th 2019, is still recruiting patients. The trial aims to enlist 20 people from 1 different clinical site."

Answered by AI

Are there any vacancies for this research trial?

"The clinical trial is still seeking applicants, according to information hosted on the website. It was first posted in March of 2019 and most recently updated in October 2022."

Answered by AI