At a glance
ClinicalIndex Comparison RecordN/ACompleted· 270 enrolled
Drug / intervention
Spinal Cord Stimulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Dorsal Spinal Cord Stimulation vs Medical Management for the Treatment of Low Back Pain (DISTINCT)
In Brief
A clinical study evaluating Spinal Cord Stimulation and Conventional Medical Management for Chronic Low-Back Pain and 2 related conditions. Completed, enrolled 270 participants across 30 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low-Back Pain, Refractory Pain, Neuropathic Pain
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartJul 2020
Primary CompletionAug 2022
Study CompletionFeb 2024
TodayJul 2026
First PostedJul 21, 2020
Enrollment StartJul 31, 2020
Primary CompletionAug 23, 2022
Study CompletionFeb 26, 2024
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.9 years ago
Interventions
Spinal Cord Stimulationdevice
Utilization of BURSTDR stimulation
Conventional Medical Managementother
Assessing type of CMM, location and frequency.