An Implantable Spinal Cord Stimulation Pain Management System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00205855
First received: September 13, 2005
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Chronic Pain
Pain, Intractable
Pain
Back Pain
Failed Back Surgery Syndrome
Device: Precision SCS
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stimulus Confirmatory Study - An Implantable Spinal Cord Stimulation Pain Management System

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting. [ Time Frame: 2 weeks post initial fitting ] [ Designated as safety issue: No ]
    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.


Enrollment: 65
Study Start Date: February 2003
Study Completion Date: March 2005
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205855

Locations
United States, Alabama
Alabama Pain Center
Huntsville, Alabama, United States, 35801
United States, California
California Pain Medicine Centers
Los Angeles, California, United States, 90059
Pacific Pain Treatment Center
San Francisco, California, United States, 94109
United States, Montana
Yellowstone Neurological Associates
Billings, Montana, United States, 59101
United States, New York
Northshore University Hospital
Syosset, New York, United States, 11791
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
Dallas Neurological Associates
Dallas, Texas, United States, 75231
River Oaks Pain Management
Houston, Texas, United States, 77027
Texas Back Institute
Plano, Texas, United States, 75093
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Chair: Kay Adair Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00205855     History of Changes
Other Study ID Numbers: CR-S-003
Study First Received: September 13, 2005
Results First Received: March 5, 2012
Last Updated: September 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Pain
Chronic Pain
Neurostimulation

Additional relevant MeSH terms:
Chronic Pain
Failed Back Surgery Syndrome
Pain, Intractable
Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014