Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)

Study Overview
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Brief Summary
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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.

Detailed Description
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A prospective, multi-center, randomized, controlled clinical study with an optional crossover component. The study is designed to evaluate the efficacy of BurstDR SCS in the treatment of chronic axial low back pain with a neuropathic component, compared to conventional medical management (CMM). Subjects will be followed in-clinic at 1,3, 6, 9, 12, 18 and 24 months and via phone call or optional clinic visit at 15- and 21-months. The primary endpoint will be assessed at the 6-month follow-up visit. Upon completion of the 6-month follow-up visit, subjects who are dissatisfied with therapy and receiving inadequate improvement with their treatment assignment will be allowed to cross-over to the other treatment arm, if desired. The study will enroll up to 270 patients at up to 30 sites. Subjects will be randomized in a 3:2 fashion to yield approximately 200 evaluable subjects for the primary endpoint analysis.

Official Title
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Dorsal Spinal Cord Stimulation vs Medical Management for the Treatment of Low Back Pain (DISTINCT)

Conditions
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Chronic Low-Back Pain, Refractory Pain, Neuropathic Pain

Intervention / Treatment
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* Device: Spinal Cord Stimulation
* Other: Conventional Medical Management


Participation Criteria
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Eligibility Criteria
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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 Oswestry Disability Index score of ≥ 30% Willing and able to comply with the instructions for use, operate the study device, and comply with this Clinical Investigation Plan Exclusion Criteria: 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: spinal instability defined as > 2 mm translation on radiographic imaging visceral causes (e.g., endometriosis or fibroids) vascular causes (e.g., aortic aneurysm) spinal infection (e.g., osteomyelitis) inflammation or damage to the spinal cord (e.g. arachnoiditis or syringomyelia) tumor or spinal metastases 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 Patient is bed bound Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma) Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicates lead placement Known allergic reaction to implanted materials Severe scoliotic deformity (>11 degrees in thoracic or lumbar spine) Patient has a history of, or existing intrathecal drug pump Patient has previous experience with neuromodulation devices, including a failed trial BMI > 40 Patient is enrolled, or intends to participate, in another clinical drug and/or device study or registry that may interfere with the results of this study, as determined by Abbott personnel Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results. Failed psychological evaluation Suspicion or evidence of untreated mental illness, or substance abuse Patient demonstrated 2 or more Waddell's signs of nonorganic behavior Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to enrollment/baseline visit per site standard test.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spinal Cord Stimulation (SCS)<br>An SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator | Device: Spinal Cord Stimulation<br>* Utilization of BURSTDR stimulation<br>* Other names: Proclaim XR IPG;|
| Active Comparator: Conventional Medical Management (CMM)<br>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) | Other: Conventional Medical Management<br>* Assessing type of CMM, location and frequency.<br>* Other names: Physical Therapy, Medications, Injections, Acupuncture, Massage Therapy, Etc.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in responders between both groups | Improvement in pain, defined as a ≥ 50% decrease on NRS | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between both groups | Change in ODI from baseline, and the percentage of change in NRS from baseline | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Low Back Pain, Spinal Cord Stimulation