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Spinal Cord Stimulation vs. Medical Management for Lower Back Pain
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have not had surgery on your spine for back or leg pain.You have had ongoing, hard-to-treat lower back pain with nerve-related symptoms for at least 6 months, and surgery is not an option for you.You have severe lower back pain, rated 6 or higher on a pain scale.Your Oswestry Disability Index score is 30% or higher.You are being considered for spinal cord stimulation treatment.You have severe lower back pain, rated 6 or higher on a pain scale.Your Oswestry Disability Index score is 30% or higher.You have had back pain for at least 6 months that did not improve with supervised conservative treatment.You have a problem with your nerves that affects your ability to move your foot.You have had ongoing, hard-to-treat lower back pain with nerve-related symptoms for at least 6 months, and surgery isn't an option for you.You are eligible for spinal cord stimulation treatment.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 back pain for more than 6 months and it hasn't improved with supervised treatments.You have not had surgery on your spine for back or leg pain.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.
- Group 1: Spinal Cord Stimulation (SCS)
- Group 2: Conventional Medical Management (CMM)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
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