Spinal Cord Stimulation for Low Back Pain

Completed · Phase 4

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT00205868

Run by

Boston Scientific Corporation

People needed

304

Starts

2004-12-01

Expected to finish

2007-12-01

Last updated by the study team

2021-06-18

Who can join

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

You may qualify if…

• Eligible for spinal cord stimulation as labeled in the FDA approval for the Precision(R) Spinal Cord Stimulator by Advanced Bionics;
• Age ≥18 years;
• Have pain of neuropathic origin;
• Have chronic pain secondary to surgical spine procedure or intractable low back pain with or without leg pain for at least 3 months and not responding to less invasive clinical procedures.

You may not qualify if…

• Enrollment in any research that would conflict with study requirements.

Where it is running

• Research Center — Cullman, Alabama, United States
• Research Center — Daphne, Alabama, United States
• Research Center — Huntsville, Alabama, United States
• Research Center — Mesa, Arizona, United States
• Research Center — Los Angeles, California, United States
• Research Center — Pasadena, California, United States
• Research Center — San Diego, California, United States
• Research Center — Westminster, Colorado, United States
• Research Center — Jacksonville, Florida, United States
• Research Center — Jupiter, Florida, United States
• Research Center — Lewiston, Idaho, United States
• Research Center — Bloomington, Illinois, United States
• Research Center — Chicago, Illinois, United States
• Research Center — Oak Brook, Illinois, United States
• Research Center — Merrillville, Indiana, United States
• Research Center — Valparaiso, Indiana, United States
• Research Center — Boston, Massachusetts, United States
• Research Center — Pittsfield, Massachusetts, United States
• Research Center — Rochester, Minnesota, United States
• Research Center — Billings, Montana, United States
• Research Center — Winston-Salem, North Carolina, United States
• Research Center — Hamilton, Ohio, United States
• Research Center — Eugene, Oregon, United States
• Research Center — Allentown, Pennsylvania, United States
• Research Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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