Trials / Withdrawn
WithdrawnNCT06030284
The True Efficacy of Burst Spinal Cord Stimulation in the Management of Intractable Low Back Pain (TRU-BURST)
The True Efficacy of Burst Spinal Cord Stimulation in the Management of Intractable Low Back Pain
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this prospective, multi-center, randomized, triple-blind, sham-controlled study with parallel economic evaluation is to test the analgesic superiority of BurstDR-SCS compared to sham stimulation using both traditional patient-reported pain outcome measures and objective physiologic data collected from patient-worn biosensors. The endpoints associated with these objectives will be studied across a follow-up period of 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BurstDR-SCS | Spinal Cord Stimulation with a BurstDR-SCS system. |
| DEVICE | BurstDR-SCS | BurstDR-SCS system turned off. |
Timeline
- Start date
- 2023-04-20
- Primary completion
- 2023-06-01
- Completion
- 2023-06-01
- First posted
- 2023-09-08
- Last updated
- 2023-11-03
Locations
5 sites across 2 countries: Canada, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06030284. Inclusion in this directory is not an endorsement.