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 range18 Years
SexALL
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Inclusion criteria
ā. Patient must be willing and able to provide written informed consent prior to any clinical investigation-related procedure.
ā. Age ā„ 18 years
ā. Patient has chronic (at least 6 months), refractory axial low back pain with a neuropathic component and is not a candidate for spine surgery
ā. Patient has back pain for ā„ 6 months inadequately responsive to supervised conservative care
ā. Patient has not had spine surgery for back or leg pain
ā. Patient is a candidate for spinal cord stimulation
ā. Low back pain ā„ 6 on Numerical Rating Scale
ā. Oswestry Disability Index score of ā„ 30%
Exclusion criteria
ā. 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.
ā. Primary complaint of leg pain, or leg pain is greater than back pain
ā. Back pain is due to any of the following:
ā. 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)