Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode

Stopped early · Not applicable

Conditions studied: Back Pain, Chronic Pain, Pain in Leg, Unspecified

In brief

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.

Key facts

Study ID

NCT00386724

Run by

Boston Scientific Corporation

People needed

8

Starts

2006-10-01

Expected to finish

2008-08-01

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States
• Neurosurgical Specialist — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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