An Implantable Spinal Cord Stimulation Pain Management System

Completed · Phase 3

Conditions studied: Chronic Pain, Pain, Intractable, Pain, Back Pain, Failed Back Surgery Syndrome

In brief

There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and nerve blocks. Historically, the mainstay of pain treatment has been pharmacotherapy. However, pharmacotherapy has varying degrees of effectiveness and is often associated with undesirable side effects. Although many patients are successfully treated, for those who fail some of these more conservative therapies the remaining option is limited to spinal cord stimulation (SCS), proven to be an effective therapy to more than half of those failing conservative treatments . Over 50% of those who have failed these more conservative methods of pain management, can now, under the guidance of a clinician utilizing SCS, have their pain levels successfully managed. SCS is a less invasive therapy that is a reversible treatment with greater long-term benefits than more permanent, radical approaches and one that deserves greater consideration in the management of chronic, intractable pain.

Key facts

Study ID

NCT00205855

Run by

Boston Scientific Corporation

People needed

65

Starts

2003-02-01

Expected to finish

2005-03-01

Last updated by the study team

2012-10-26

Who can join

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

You may qualify if…

• Diagnosed with chronic, intractable pain of the trunk and/or limbs which includes but is not limited to, unilateral or bilateral pain associated with any of the following: failed back surgery syndrome, intractable low back pain and leg pain.
• Be an appropriate candidate for surgery.
• Be capable of giving informed consent.
• Be capable and willing to follow all study related procedures.

You may not qualify if…

• Have an inability to operate the system either by self or care-giver.
• Are currently participating or have participated within the past 30 days in any clinical investigation that could conflict with the requirements of this study.
• Have any implanted electrical devices, regardless of whether active or inactive.
• Have any active implantable device regardless of whether stimulation is ON or OFF.

Where it is running

• Alabama Pain Center — Huntsville, Alabama, United States
• California Pain Medicine Centers — Los Angeles, California, United States
• Pacific Pain Treatment Center — San Francisco, California, United States
• Yellowstone Neurological Associates — Billings, Montana, United States
• Northshore University Hospital — Syosset, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Dallas Neurological Associates — Dallas, Texas, United States
• River Oaks Pain Management — Houston, Texas, United States
• Texas Back Institute — Plano, Texas, United States

Full record on ClinicalTrials.gov

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