Clinical Trial: SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Interventional, Prospective, Multicenter, Randomized, Parallel-arm Study to Compare the Effectiveness of Peripheral Nerve Stimulation (PNS) Utilizing a Subcutaneous Lead Implant Technique (SQS) Plus O

Brief 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).

Detailed Summary:
Sponsor: Medtronic International Trading Sarl

Current Primary Outcome: Effectiveness of treatment on reduction of back pain intensity. [ Time Frame: 9 months ]

VAS scales will be used to determine the effectiveness of treatments on the reduction of back pain intensity.


Original Primary Outcome: Same as current

Current Secondary Outcome: Greater Average Change in Back Pain [ Time Frame: 6 and 9 months ]

VAS scales will be used to determine the effectiveness of treatments on the average change of back pain intensity.


Original Secondary Outcome: Same as current

Information By: Medtronic International Trading Sarl

Dates:
Date Received: July 12, 2012
Date Started: November 2012
Date Completion:
Last Updated: September 23, 2016
Last Verified: September 2016