NCT01036529

Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome

Spinal Cord Stimulation With Precision® Spinal Cord Stimulation System Versus Reoperation for Failed Back Surgery Syndrome

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). FBSS is defined as persistent or recurrent pain following one or more lumbosacral spine surgical procedures. Surgical procedures that can result in FBSS can be categorized as either decompression or decompression followed by fusion with or without instrumentation. The pain of FBSS is categorized as neuropathic, which involves pathological nerve activity and is commonly characterized by patients as shooting or burning and/or nociceptive, which signals actual or impending tissue damage or inflammation.

Detailed description

The co-primary study endpoints are proportion of subjects with ≥50% leg pain relief without crossover at 6 and at 24 months.

Conditions

• Failed Back Surgery Syndrome
• Pain
• Back Pain

Interventions

Type	Name	Description
DEVICE	Precision Spinal Cord Stimulator	Programming settings will be specific to the individual needs in accordance with the labeling
PROCEDURE	Back Surgery	Different types of back surgery may be performed

Timeline

• Start date: 2010-02-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2009-12-21
• Last updated: 2020-11-16
• Results posted: 2013-10-28

Locations

18 sites across 4 countries: United States, Canada, France, United Kingdom