Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT) (NCT04479787) | Clinical Trial Compass
CompletedNot Applicable
Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)
United States270 participantsStarted 2020-07-31
Plain-language summary
The objective of this study is to evaluate the efficacy of BurstDR dorsal column stimulation, compared with conventional medical management, in improving pain and back-related physical function in subjects suffering with chronic, refractory axial low back pain with a neuropathic component, who have not had lumbar spine surgery and for whom surgery is not an option.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient must be willing and able to provide written informed consent prior to any clinical investigation-related procedure.
. Age ≥ 18 years
. 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
. Patient has not had spine surgery for back or leg pain
. Patient is a candidate for spinal cord stimulation
. Low back pain ≥ 6 on Numerical Rating Scale
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Pathology seen on imaging tests obtained within the past 12 months that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery.
. Primary complaint of leg pain, or leg pain is greater than back pain
. Back pain is due to any of the following:
. Has widespread pain (e.g. fibromyalgia) or pain in other area(s), not intended to be treated in this study (e.g. neck pain, shoulder pain)
. Patient has seronegative spondyloarthropathy (e.g. rheumatoid, lupus, psoriatic)
. Neurological deficit (e.g. foot drop)
. Prior lumbar spine surgery or sacroiliac joint fusion
. Patient has used a morphine equivalent daily dose of more than 50 MME in the last 30 days