Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode
TerminatedNot applicableNCT00386724
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The primary objective of this study is to evaluate the acute and chronic efficacy of spinal cord stimulation using the Precision implantable neurostimulation device with the Artisan paddle electrode in patients with Failed Back Surgery Syndrome (FBSS) and associated primary or secondary back or lower extremity pain. There are significant numbers of patients with FBSS who have moderate to severe drug refractory pain. An optimal outcome will demonstrate that the Precision SCS device has significant effectiveness in reducing this pain resulting in improved quality of life and functional capacity.
Study details
- Official title
- Effectiveness of the Precision Spinal Cord Stimulation System With the Artisan Paddle Electrode in Patients With Back or Lower Extremity Pain
- Conditions
- Back Pain
- Chronic Pain
- Pain in Leg, Unspecified
- Interventions
- Device: Precision Spinal Cord Stimulation System
- Device: Artisan Surgical Lead
- Sponsor
- Boston Scientific Corporation
- Start date
- 2006-10
- Primary completion
- 2008-08
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Have FBSS with moderate to severe back or lower extremity pain of at least 3 months duration, be an appropriate candidate for SCS, and have independently elected SCS therapy with the Precision system as next line therapy; * Be 18 years of age or older; * Be willing and able to comply with all study related procedures and visits; * Be capable of reading and understanding patient information materials and giving written informed consent. Exclusion Criteria: * Have low back pain as the primary complaint; * Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints; * Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other study during the year.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00386724