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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
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.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The Difference in Responders Between Both Groups
Secondary study objectives
Measure of Composite Responder Rate
Numerical Rating Scale (NRS) Relative Change From Baseline to 6 Months
Oswestry Disability Index (ODI) Change From Baseline to 6 Months
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
BurstDR Dorsal Column Stimulation (DCS) and other neuromodulation techniques for Chronic Low Back Pain (CLBP) work by altering pain signal transmission at the spinal cord and brain levels. DCS uses specific waveforms and temporal patterns to inhibit pain pathways and activate pain-inhibitory mechanisms, providing relief by reducing the perception of pain.
This is crucial for CLBP patients as it offers an alternative when conventional medical management fails, targeting the pain at its source and potentially improving quality of life. Other interventional therapies, such as epidural steroid injections and nerve blocks, aim to reduce inflammation and interrupt pain signals, offering short-term relief and complementing rehabilitation and pharmacotherapy.
The effect of dorsal column stimulation on the nociceptive response of dorsal horn cells and its relevance for pain suppression.Mechanism of Action in Burst Spinal Cord Stimulation: Review and Recent Advances.
The effect of dorsal column stimulation on the nociceptive response of dorsal horn cells and its relevance for pain suppression.Mechanism of Action in Burst Spinal Cord Stimulation: Review and Recent Advances.
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Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
650 Previous Clinical Trials
416,073 Total Patients Enrolled
James Yue, MDPrincipal Investigator
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have a type of arthritis called seronegative spondyloarthropathy, which includes conditions like rheumatoid arthritis, lupus, and psoriatic arthritis.You have had surgery on your lower back or sacroiliac joint fusion before.You have been taking a strong pain medication equivalent to more than 50 milligrams of morphine every day for the past month.You have a specific problem in your back that has been seen on a recent imaging test and could be fixed with surgery.You mainly have pain in your legs, or your leg pain is worse than your back pain.Your back pain is caused by too much movement of the bones in your spine, as seen on an x-ray or other imaging tests.Your back pain is caused by internal organs like the uterus or ovaries.Your back pain is caused by a problem with your blood vessels, like an aortic aneurysm.Your back pain is caused by a spinal infection, like osteomyelitis.Your back pain is caused by inflammation or damage to the spinal cord.You have untreated mental illness or substance abuse.The patient shows two or more signs of behaving in a way that is not related to a physical illness.Women who could become pregnant must have a negative pregnancy test within 7 days before joining the study.You are unable to leave your bed.You take steroids regularly, except for using an inhaler to treat asthma.Your recent imaging results show that it's not safe for the lead to be placed.You have had an allergic reaction to implanted materials in the past.You have a severe curve in your spine.You have used or are currently using a drug pump in your spine.You have used neuromodulation devices before, including a trial that did not work.You have a body mass index (BMI) higher than 40.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.You have had back pain for at least 6 months that hasn't gotten better with supervised treatments.You have not had surgery on your spine for back or leg pain.You are being considered for spinal cord stimulation treatment.You have severe lower back pain, rated 6 or higher on a pain scale.You have a disability that affects at least 30% of your daily activities, like walking or lifting things.
Research Study Groups:
This trial has the following groups:- Group 1: Spinal Cord Stimulation (SCS)
- Group 2: Conventional Medical Management (CMM)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Low Back Pain Patient Testimony for trial: Trial Name: NCT04479787 — N/A
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