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

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT04479787

Run by

Abbott Medical Devices

People needed

270

Starts

2020-07-31

Expected to finish

2024-02-26

Last updated by the study team

2025-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barrow Brain & Spine — Phoenix, Arizona, United States
• Banner University Medical Center — Tucson, Arizona, United States
• Spanish Hills Interventional Pain Specialists — Camarillo, California, United States
• Coastal Pain & Spinal Diagnostics Medical Group — Carlsbad, California, United States
• Napa Valley Orthopedic Medical Group — Napa, California, United States
• Connecticut Orthopedic Specialists — Hamden, Connecticut, United States
• International Spine, Pain & Performance Center — Washington D.C., District of Columbia, United States
• The Orthopedic Institute — Gainesville, Florida, United States
• Anesthesia Pain Care Consultants — Tamarac, Florida, United States
• Axis Spine Center — Coeur d'Alene, Idaho, United States
• Chicago Anesthesia Associates — Chicago, Illinois, United States
• Northshore University Health System — Evanston, Illinois, United States
• Indiana Spine Group — Carmel, Indiana, United States
• Goodman Campbell Brain & Spine — Indianapolis, Indiana, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Louis Pain Consultants — Chesterfield, Missouri, United States
• Advanced Pain Care — Henderson, Nevada, United States
• Nevada Advanced Pain Specialists — Reno, Nevada, United States
• Albany Medical Center — Albany, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Spinal Diagnostics — Tualatin, Oregon, United States
• Center for Interventional Pain & Spine — Exton, Pennsylvania, United States

Full record on ClinicalTrials.gov

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