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Spinal Cord Stimulation for Low Back Pain

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00205868
First received: September 13, 2005
Last updated: October 10, 2008
Last verified: October 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Pain
 Device: Precision Spinal Cord Stimulation System
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of the Precision Spinal Cord Stimulation System in Patients With Failed Back Surgery Syndrome and Axial Low Back Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 304
Study Start Date: December 2004
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Precision Spinal Cord Stimulation System
    Stimulation on throughout study
  Eligibility

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

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205868

  Show 30 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Ramsin Benyamin, MD Millenium Pain Center
  More Information

No publications provided

Responsible Party: Lyn Pimentel, Clinical Project Manager, Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00205868     History of Changes
Other Study ID Numbers: PM -SCS -120904
Study First Received: September 13, 2005
Last Updated: October 10, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Back Pain
Low Back Pain
Chronic Pain
Spinal Cord Stimulation

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

ClinicalTrials.gov processed this record on May 21, 2013