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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

September 13, 2005
September 26, 2012
February 2003
October 2003   (final data collection date for primary outcome measure)
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.
Demonstrate acceptable functionality and labeling in the use of the system
Complete list of historical versions of study NCT00205855 on ClinicalTrials.gov Archive Site
Not Provided
Support future update to claims
Not Provided
Not Provided
 
An Implantable Spinal Cord Stimulation Pain Management System
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.

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.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Pain
  • Pain, Intractable
  • Pain
  • Back Pain
  • Failed Back Surgery Syndrome
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)
Experimental: Precision SCS
Precision SCS. Patients who receive Precision Spinal Cord Stimulator (SCS) Stimulus system
Intervention: Device: Precision SCS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
March 2005
October 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00205855
CR-S-003
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Study Chair: Kay Adair Boston Scientific Corporation
Boston Scientific Corporation
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP