NCT04479787

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

Dorsal Spinal Cord Stimulation vs Medical Management for the Treatment of Low Back Pain (DISTINCT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Spinal Cord Stimulation	Utilization of BURSTDR stimulation
OTHER	Conventional Medical Management	Assessing type of CMM, location and frequency.

Timeline

• Start date: 2020-07-31
• Primary completion: 2022-08-23
• Completion: 2024-02-26
• First posted: 2020-07-21
• Last updated: 2025-02-03
• Results posted: 2024-06-18

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated device study