Spinal Cord Stimulation for Low Back Pain
Effectiveness of the Precision Spinal Cord Stimulation System in Patients With Failed Back Surgery Syndrome and Axial Low Back Pain
1 other identifier
interventional
304
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 chronic-pain
Started Dec 2004
Typical duration for phase_4 chronic-pain
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
June 18, 2021
CompletedJune 18, 2021
May 1, 2021
2.9 years
September 13, 2005
March 31, 2021
May 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 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"
1 year
Effectiveness of SCS Stimulation in Reducing Leg 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 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"
1 year
Secondary Outcomes (1)
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
1 year
Interventions
Stimulation on throughout study
Eligibility Criteria
You may qualify if:
- Eligible for spinal cord stimulation as labeled in the FDA approval for the Precision(R) Spinal Cord Stimulator by Advanced Bionics;
- Age ≥18 years;
- Have pain of neuropathic origin;
- 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.
You may not qualify if:
- \. Enrollment in any research that would conflict with study requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Research Center
Cullman, Alabama, 35055, United States
Research Center
Daphne, Alabama, 36526, United States
Research Center
Huntsville, Alabama, 35801, United States
Research Center
Mesa, Arizona, 85206, United States
Research Center
Los Angeles, California, 90095, United States
Research Center
Pasadena, California, 91105, United States
Research Center
San Diego, California, 92108, United States
Research Center
Westminster, Colorado, 80401, United States
Research Center
Jacksonville, Florida, 32224, United States
Research Center
Jupiter, Florida, 33477, United States
Research Center
Lewiston, Idaho, 83501, United States
Research Center
Bloomington, Illinois, 61701, United States
Research Center
Chicago, Illinois, 60611, United States
Research Center
Oak Brook, Illinois, 60707, United States
Research Center
Merrillville, Indiana, 46410, United States
Research Center
Valparaiso, Indiana, 46410, United States
Research Center
Boston, Massachusetts, 02215, United States
Research Center
Pittsfield, Massachusetts, 01201, United States
Research Center
Rochester, Minnesota, 55904, United States
Research Center
Billings, Montana, 59101, United States
Research Center
Winston-Salem, North Carolina, 27103, United States
Research Center
Hamilton, Ohio, 45011, United States
Research Center
Eugene, Oregon, 97401, United States
Research Center
Allentown, Pennsylvania, 18104, United States
Research Center
Philadelphia, Pennsylvania, 19107, United States
Research Center
Spartanburg, South Carolina, 29302, United States
Research Center
Murray, Utah, 84107, United States
Research Center
Provo, Utah, 84604, United States
Research Center
Cudahy, Wisconsin, 53220, United States
Research Center
Rice Lake, Wisconsin, 54868, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research Sciences
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Ramsin Benyamin, MD
Millenium Pain Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
December 1, 2004
Primary Completion
November 1, 2007
Study Completion
December 1, 2007
Last Updated
June 18, 2021
Results First Posted
June 18, 2021
Record last verified: 2021-05