Trials / Terminated
TerminatedNCT01711619
SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients
Interventional, Prospective, Multicenter, Randomized, Parallel-arm Study to Compare the Effectiveness of Peripheral Nerve Stimulation (PNS) Utilizing a Subcutaneous Lead Implant Technique (SQS) Plus Optimized Medical Management (OMM) Versus OMM Alone in Patients Suffering From Back Pain Due to Failed Back Surgery Syndrome (FBSS)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 162 (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 peripheral nerve stimulation utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management (OMM) versus OMM alone in patients suffering from back pain due to Failed Back Surgery Syndrome (FBSS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | subcutaneous nerve stimulation | subcutaneous nerve stimulation plus optimized medical management |
| OTHER | Optimized Medical Management | Optimized medical management |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2016-02-01
- Completion
- 2016-02-01
- First posted
- 2012-10-22
- Last updated
- 2018-10-22
- Results posted
- 2018-10-22
Locations
26 sites across 10 countries: Australia, Austria, Belgium, France, Germany, Israel, Netherlands, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01711619. Inclusion in this directory is not an endorsement.