← Back to Search

Spinal Cord Stimulation

Spinal Cord Stimulation vs. Medical Management for Lower Back Pain

N/A
Waitlist Available
Led By James Yue, MD
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has chronic (at least 6 months), refractory axial low back pain with a neuropathic component and is not a candidate for spine surgery
Patient has back pain for ≥ 6 months inadequately responsive to supervised conservative care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will compare a new pain relief method (BurstDR dorsal column stimulation) to standard care (comprehensive medical management) in people with chronic back pain that hasn't improved with other treatments and can't have surgery.

Who is the study for?
This trial is for adults over 18 with chronic low back pain lasting at least 6 months, which hasn't improved after standard treatments and isn't suitable for surgery. Participants should have a pain score of ≥6 and disability index of ≥30%, be eligible for spinal cord stimulation, and not have had previous spine surgeries or conditions that could explain their pain.Check my eligibility
What is being tested?
The study compares BurstDR spinal cord stimulation to conventional medical management in improving pain and physical function in patients with chronic axial low back pain with neuropathic characteristics who are not candidates for lumbar spine surgery.See study design
What are the potential side effects?
Potential side effects from spinal cord stimulation can include discomfort at the implant site, unwanted changes in stimulation, nerve injury, and infection. Conventional medical management side effects depend on the specific treatments used but may include medication-related issues like stomach upset or drowsiness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have had ongoing, hard-to-treat lower back pain with nerve-related symptoms for at least six months, and surgery is not an option for you.
Select...
You have had back pain for at least 6 months that hasn't gotten better with supervised treatments.
Select...
You have not had surgery on your spine for back or leg pain.
Select...
You are being considered for spinal cord stimulation treatment.
Select...
You have severe lower back pain, rated 6 or higher on a pain scale.
Select...
You have a disability that affects at least 30% of your daily activities, like walking or lifting things.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The difference in responders between both groups
Secondary outcome measures
Comparison between both groups

Trial Design

2Treatment groups
Active Control
Group I: Spinal Cord Stimulation (SCS)Active Control1 Intervention
An SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator
Group II: Conventional Medical Management (CMM)Active Control1 Intervention
CMM consists of an array of therapies including, but not limited to structured physical therapy, medications, injections, and complementary and alternative medicine (e.g. acupuncture, massage therapy)

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
635 Previous Clinical Trials
404,965 Total Patients Enrolled
James Yue, MDPrincipal Investigator
1 Previous Clinical Trials
15 Total Patients Enrolled

Media Library

Spinal Cord Stimulation (Spinal Cord Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04479787 — N/A
Chronic Low Back Pain Research Study Groups: Spinal Cord Stimulation (SCS), Conventional Medical Management (CMM)
Chronic Low Back Pain Clinical Trial 2023: Spinal Cord Stimulation Highlights & Side Effects. Trial Name: NCT04479787 — N/A
Spinal Cord Stimulation (Spinal Cord Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04479787 — N/A
Chronic Low Back Pain Patient Testimony for trial: Trial Name: NCT04479787 — N/A

Frequently Asked Questions

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

Are there still enrollments for this research protocol?

"According to the information aggregated on clinicaltrials.gov, this particular medical study is not currently enrolling patients. The trial was first posted in July 2020 and last edited in April 2022. In contrast, 494 other trials are actively recruiting at present."

Answered by AI

In which geographical areas is the trial being managed?

"Burkhart Research Institute for Orthopaedics in San Antonio, Axis Spine Center in Coeur d'Alene, and Anesthesia Pain Care Consultants in Tamarac are amongst the 28 recruiting sites that have been identified to participate this investigation."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Florida
California
Other
What site did they apply to?
The Orthopedic Institute
Anesthesia Pain Care Consultants
Coastal Pain & Spinal Diagnostics Medical Group
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
1
3+

Why did patients apply to this trial?

I’m sick of being in pain. Looking for medical proof linking Neuropathy and Back Pain.
PatientReceived no prior treatments
I have give multiple options of treatment with no resolution. I’ve tried natural methods and yoga. Nothing works. The nerve ain is unbearable.
PatientReceived 2+ prior treatments
I'm have severe and chronic low back pain and neck/back pain for years. It has become very disabling and I'm truly hoping that you can consider me for your clinical trial.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Is this a paid trial? Could the trial make my pain worse? How long is the trial? What is expected from me in this study. ?
PatientReceived 1 prior treatment
~59 spots leftby Mar 2025