Trials / Completed
CompletedNCT04676022
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery
A Randomized Controlled Study to Evaluate the Safety and Effectiveness of Boston Scientific Spinal Cord Stimulation (SCS) Systems in the Treatment of Chronic Low Back and/or Leg Pain With No Prior Surgeries
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 241 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | WaveWriter | To receive Spinal Cord Stimulation programming |
| OTHER | Conventional Medical Managament | To receive conventional medical management |
Timeline
- Start date
- 2021-03-26
- Primary completion
- 2022-08-25
- Completion
- 2025-02-21
- First posted
- 2020-12-19
- Last updated
- 2025-03-06
- Results posted
- 2024-05-08
Locations
23 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04676022. Inclusion in this directory is not an endorsement.