Skip to content

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

CompletedNot applicableNCT04479787
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Dorsal Spinal Cord Stimulation vs Medical Management for the Treatment of Low Back Pain (DISTINCT)
Conditions
Interventions
Sponsor
Abbott Medical Devices
Start date
2020-07-31
Primary completion
2022-08-23
Sex
All
Age range
from 18 Years
Healthy volunteers
true
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
30

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Patient must be willing and able to provide written informed consent prior to any clinical investigation-related procedure. 2. Age ≥ 18 years 3. Patient has chronic (at least 6 months), refractory axial low back pain with a neuropathic component and is not a candidate for spine surgery 4. Patient has back pain for ≥ 6 months inadequately responsive to supervised conservative care 5. Patient has not had spine surgery for back or leg pain 6. Patient is a candidate for spinal cord stimulation 7. Low back pain ≥ 6 on Numerical Rating Scale 8. Oswestry Disability Index score of ≥ 30% 9. Willing and able to comply with the instructions for use, operate the study device, and comply with this Clinical Investigation Plan Exclusion Criteria: 1. 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. 2. Primary complaint of leg pain, or leg pain is greater than back pain 3. 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 4. 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) 5. Patient has seronegative spondyloarthropathy (e.g. rheumatoid, lupus, psoriatic) 6. Neurological deficit (e.g. foot drop) 7. Prior lumbar spine surgery or sacroiliac joint fusion 8. Patient has used a morphine equivalent daily dose of more than 50 MME in the last 30 days 9. Patient is bed bound 10. Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma) 11. Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicates lead placement 12. Known allergic reaction to implanted materials 13. Severe scoliotic deformity (\>11 degrees in thoracic or lumbar spine) 14. Patient has a history of, or existing intrathecal drug pump 15. Patient has previous experience with neuromodulation devices, including a failed trial 16. BMI \> 40 17. 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 person…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04479787