Effect of Pulse Width With Spinal Cord Stimulation
The Effect of Pulse Width on the Treatment of Chronic Low Back Pain With Spinal Cord Stimulation
1 other identifier
interventional
21
1 country
1
Brief Summary
The primary objective of this study is to assess the effects of varying pulse width in suprathreshold dorsal column stimulation in patients with low back pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 pain
Started Nov 2006
1 active site
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
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 13, 2006
CompletedFirst Posted
Study publicly available on registry
November 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
April 4, 2012
CompletedApril 4, 2012
March 1, 2012
11 months
November 13, 2006
February 13, 2012
March 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)
Pain severity as measured by NRS quantifies pain, where 0 is "no pain" and 10 is "worst pain imaginable"
Within 6 months post-implantation
Interventions
Eligibility Criteria
You may qualify if:
- Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome), which is primarily located in the low back, with minimal lower extremity pain.
- Have been permanently implanted with a Precision spinal cord stimulation (SCS) system within 6 months, or be an appropriate candidate for SCS and for the surgical procedures required for SCS as determined by the physician and have independently selected SCS with Precision for treatment.
- Be 18 years of age or older.
- Be willing and able to comply with all study related procedures and visits.
- Be capable of reading and understanding patient information materials and giving written informed consent.
You may not qualify if:
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
- Have any other chronic pain condition likely to confound evaluation of study endpoints.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Comprehensive Pain Management and Rehabilitation
Daphne, Alabama, 36526, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brad Hershey, MS
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Yearwood, MD
Comprehensive Pain and Rehabilitation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2006
First Posted
November 15, 2006
Study Start
November 1, 2006
Primary Completion
October 1, 2007
Study Completion
November 1, 2007
Last Updated
April 4, 2012
Results First Posted
April 4, 2012
Record last verified: 2012-03