Spinal Cord Stimulation vs. Medical Management for Lower Back Pain

Recruiting in Palo Alto (17 mi)

+31 other locations

Overseen byJames Yue, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Abbott Medical Devices

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing BurstDR SCS, a therapy that uses electrical pulses to reduce pain by stimulating the spinal cord. It targets patients with chronic low back pain who haven't found relief from other treatments and can't undergo surgery. The electrical pulses help block pain signals from reaching the brain. BurstDR SCS is a new type of stimulation that has shown better results compared to older methods in treating chronic pain.

Eligibility Criteria

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.

Inclusion Criteria

Patient must be willing and able to provide written informed consent prior to any clinical investigation-related procedure

Age ≥ 18 years

Willing and able to comply with the instructions for use, operate the study device, and comply with this Clinical Investigation Plan

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Exclusion Criteria

You have a problem with your nerves that affects your ability to move your foot.

You have back pain caused by a tumor or cancer spreading to the spine.

You have widespread pain, like fibromyalgia, or pain in areas that are not the focus of this study, like neck or shoulder pain.

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Treatment Details

Interventions

Comprehensive Medical Management (Other)
Conventional Medical Management (Other)
Spinal Cord Stimulation (Spinal Cord Stimulation)

Trial OverviewThe 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.

Participant Groups

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)

Spinal Cord Stimulation is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Spinal Cord Stimulation for: