Status:
COMPLETED
Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)
Lead Sponsor:
Abbott Medical Devices
Conditions:
Chronic Low-Back Pain
Refractory Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 sub...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2024
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04479787
Start Date
July 31 2020
End Date
February 26 2024
Last Update
February 3 2025
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
Barrow Brain & Spine
Phoenix, Arizona, United States, 85048
2
Banner University Medical Center
Tucson, Arizona, United States, 85724
3
Spanish Hills Interventional Pain Specialists
Camarillo, California, United States, 93010
4
Coastal Pain & Spinal Diagnostics Medical Group
Carlsbad, California, United States, 92009