Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)
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|ClinicalTrials.gov Identifier: NCT04479787|
Recruitment Status : Active, not recruiting
First Posted : July 21, 2020
Last Update Posted : January 6, 2023
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low-Back Pain Refractory Pain Neuropathic Pain||Device: Spinal Cord Stimulation Other: Conventional Medical Management||Not Applicable|
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 low back pain with a neuropathic component, compared to conventional medical management (CMM).
Subjects will be followed in-clinic at 1,3, 6, 9, 12, 18 and 24 months and via phone call or optional clinic visit at 15- and 21-months. The primary endpoint will be assessed at the 6-month follow-up visit. Upon completion of the 6-month follow-up visit, subjects who are dissatisfied with therapy and receiving inadequate improvement with their treatment assignment will be allowed to cross-over to the other treatment arm, if desired.
The study will enroll up to 270 patients at up to 30 sites. Subjects will be randomized in a 3:2 fashion to yield approximately 200 evaluable subjects for the primary endpoint analysis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||270 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dorsal Spinal Cord Stimulation vs Medical Management for the Treatment of Low Back Pain (DISTINCT)|
|Actual Study Start Date :||July 31, 2020|
|Actual Primary Completion Date :||August 23, 2022|
|Estimated Study Completion Date :||January 31, 2024|
Active Comparator: Spinal Cord Stimulation (SCS)
An SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator
Device: Spinal Cord Stimulation
Utilization of BURSTDR stimulation
Other Name: Proclaim XR IPG
Active Comparator: Conventional Medical Management (CMM)
CMM consists of an array of therapies including, but not limited to structured physical therapy, medications, injections, and complementary and alternative medicine (e.g. acupuncture, massage therapy)
Other: Conventional Medical Management
Assessing type of CMM, location and frequency.
Other Name: Physical Therapy, Medications, Injections, Acupuncture, Massage Therapy, Etc.
- The difference in responders between both groups [ Time Frame: 6 Months ]Improvement in pain, defined as a ≥ 50% decrease on NRS
- Comparison between both groups [ Time Frame: 6 Months ]Change in ODI from baseline, and the percentage of change in NRS from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04479787
|Principal Investigator:||James Yue, MD|