At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Pain of neuropathic origin
- ✓Chronic pain secondary to surgical spine procedure or intractable low back pain for at least 3 months
- ✓Pain not responding to less invasive clinical procedures
- ✕Enrollment in any conflicting research studies
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effectiveness of the Precision Spinal Cord Stimulation System in Patients With Failed Back Surgery Syndrome and Axial Low Back Pain
In Brief
A Phase 4 clinical trial evaluating Precision Spinal Cord Stimulation System for Chronic Pain. Completed, enrolled 304 participants across 30 sites.
Detailed Summary
The purpose of this study is to assess the acute and chronic effectiveness of the Advanced Bionics Precision(TM) Spinal Cord Stimulation System in subjects with failed back surgery syndrome and associated low back axial pain. Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.
Study Details
Timeline
Interventions
Stimulation on throughout study