Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)
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|ClinicalTrials.gov Identifier: NCT04479787|
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : November 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low-Back Pain Refractory Pain Neuropathic Pain||Device: Spinal Cord Stimulation Other: Comprehensive 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 comprehensive 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)|
|Estimated 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|
|Estimated Primary Completion Date :||July 31, 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: Comprehensive 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: Comprehensive 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 function, defined as a ≥ 13% decrease on ODI or score ≤ 20%, OR Improvement in pain, defined as a ≥ 50% decrease on NRS
- Proportion of patients who elect to cross-over after the Primary Outcome [ Time Frame: 6 Months ]
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
|Contact: Todd Stirman||972-526-9625||Todd.email@example.com|
|Contact: Robyn Capobianco||512-286-4274||Robyn.firstname.lastname@example.org|
|Principal Investigator:||James Yue, MD|