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Spinal Cord Stimulation for Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00205868
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : June 17, 2021
Last Update Posted : June 17, 2021
Sponsor:
Information provided by:
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Results First Submitted Date  ICMJE March 31, 2021
Results First Posted Date  ICMJE June 17, 2021
Last Update Posted Date June 17, 2021
Actual Study Start Date  ICMJE December 2004
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2021)
  • Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use. [ Time Frame: 1 year ]
    Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"
  • Effectiveness of SCS Stimulation in Reducing Leg Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use. [ Time Frame: 1 year ]
    Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
  • Effectiveness of SCS Stimulation in Reducing Leg Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2008)
Percentage of Patients Who Achieve a Significant Clinical Reduction in Back Pain Defined as >50% Reduction in VAS Score With Stimulation Compared With no Stimulation [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Percentage of Patients Who Achieve a Significant Clinical Reduction in Back Pain Defined as >50% Reduction in VAS Score With Stimulation Compared With no Stimulation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spinal Cord Stimulation for Low Back Pain
Official Title  ICMJE Effectiveness of the Precision Spinal Cord Stimulation System in Patients With Failed Back Surgery Syndrome and Axial Low Back Pain
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE Device: Precision Spinal Cord Stimulation System
Stimulation on throughout study
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2008)
304
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
200
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Eligible for spinal cord stimulation as labeled in the FDA approval for the Precision(R) Spinal Cord Stimulator by Advanced Bionics;
  2. Age ≥18 years;
  3. Have pain of neuropathic origin;
  4. 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.

Exclusion Criteria:

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00205868
Other Study ID Numbers  ICMJE PM -SCS -120904
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lyn Pimentel, Clinical Project Manager, Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ramsin Benyamin, MD Millenium Pain Center
PRS Account Boston Scientific Corporation
Verification Date May 2021

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