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

NCT04479787 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2025-02-03

Study results available
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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.

Conditions

  • Chronic Low-Back Pain
  • Refractory Pain
  • Neuropathic Pain

Interventions

DEVICE

Spinal Cord Stimulation

Utilization of BURSTDR stimulation

OTHER

Conventional Medical Management

Assessing type of CMM, location and frequency.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • James Yue, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2022-08-23
Completion
2024-02-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04479787 on ClinicalTrials.gov