An Implantable Spinal Cord Stimulation Pain Management System

September 26, 2012 updated by: Boston Scientific Corporation

Stimulus Confirmatory Study - An Implantable Spinal Cord Stimulation Pain Management System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This clinical trial was a confirmatory study for the Advanced Bionics totally implantable Spnial Cord Stimulation(SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: Dailed back surgery syndrome, intractable low backpain and leg pain.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Alabama Pain Center
    • California
      • Los Angeles, California, United States, 90059
        • California Pain Medicine Centers
      • San Francisco, California, United States, 94109
        • Pacific Pain Treatment Center
    • Montana
      • Billings, Montana, United States, 59101
        • Yellowstone Neurological Associates
    • New York
      • Syosset, New York, United States, 11791
        • Northshore University Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Texas
      • Dallas, Texas, United States, 75231
        • Dallas Neurological Associates
      • Houston, Texas, United States, 77027
        • River Oaks Pain Management
      • Plano, Texas, United States, 75093
        • Texas Back Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Be an appropriate candidate for surgery.
  3. Be capable of giving informed consent.
  4. Be capable and willing to follow all study related procedures.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Precision SCS
Precision SCS. Patients who receive Precision Spinal Cord Stimulator (SCS) Stimulus system
Device: Precision SCS
Advanced Bionics totally implantable Spinal Cord Stimulation (SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.
Other Names:
  • Stimulus System
  • PRECISION Spinal Cord Stimulator System (PRECISION System)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting.
Time Frame: 2 weeks post initial fitting
The VAS score is rated by the patient for the average pain level within the past 7 days where on a scale of 0 to 10, 0 is equal to"no pain" and 10 is equal to "worst pain imaginable." This measurement is captured at baseline and again at 2 weeks post intitial fitting. The measurement is the percent difference between the VAS at 2 weeks post intital fitting from the baseline VAS.
2 weeks post initial fitting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Chair: Kay Adair, Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

October 26, 2012

Last Update Submitted That Met QC Criteria

September 26, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-S-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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