Trials / Completed
CompletedNCT01697358
Spinal Cord Stimulation for Predominant Low Back Pain
Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 278 (actual)
- Sponsor
- MedtronicNeuro · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).
Detailed description
The study has a multi-center, prospective, randomized (1:1), open-label, parallel-group design of two alternative treatments: * SCS group (SCS+OMM) * OMM group
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Spinal Cord Stimulation (SCS) | Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead. Subjects will undergo an SCS screening test and, if successful, an implantable neurostimulation system implant. Any SCS group subject not implanted will continue to be treated with OMM and will be followed as part of the SCS group. |
| DRUG | Optimal Medical Management (OMM) | The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies. |
Timeline
- Start date
- 2013-01-08
- Primary completion
- 2016-03-12
- Completion
- 2017-06-20
- First posted
- 2012-10-02
- Last updated
- 2017-07-21
- Results posted
- 2017-06-14
Locations
28 sites across 9 countries: United States, Belgium, Canada, Colombia, France, Germany, Netherlands, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01697358. Inclusion in this directory is not an endorsement.