Optimized Programming in Spinal Cord Stimulation (SCS) System (OP)
Primary Purpose
Neuropathic Pain, Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Precision Spinal Cord Stimulation (SCS)
Sponsored by
About this trial
This is an interventional supportive care trial for Neuropathic Pain focused on measuring Spinal Cord Stimulation
Eligibility Criteria
Inclusion Criteria:
- Be previously implanted with Precision SCS System (3-36 months post permanent implant) having 2 parallel percutaneous leads placed between T8-T10.
- Be implanted with Precision SCS System for the treatment of neuropathic pain of trunk and/or limbs
- Be 18 years of age or older
- Be extremely satisfied, very satisfied, or satisfied with SCS therapy for treatment of pain condition
- Be able to use pen tablet to document regions of paresthesia and pain
- Be able to lie in the supine position for 45 minutes at a minimum
- Be able to verbally report qualitative and quantitative aspects of paresthesia sensations.
- Have a paresthesia threshold on a standard program below 4mA while in the supine position
- Have at minimum the upper contact of one lead below T8 and the lower contact above T11 vertebral levels
- Be willing and able to comply with study-related procedure
- Agree to study requirements and provides written Informed Consent
Exclusion Criteria:
- Unable to read, write, speak, and understand English
- Currently pregnant or planning to become pregnant during the course of the study
- Have negative finding in any of the pre-screening and screening requirements
- Upon fluoroscopy, location of both leads is identified to be outside T8-T10 vertebral levels
- Unable to perceive the sensation of paresthesia associated with stimulation in the trunk and/or lower extremities
- Have a drug pump and/or a non-Precision neurostimulation device (regardless of whether active or inactive)
- Have had any interventional pain procedure or surgeries (including Interlaminar epidural steroid injection, Transforaminal epidural steroid injection, Caudal epidural steroid injection, Selective nerve root block, Intraarticular lumbar facet injection, Sacroiliac joint injection, Piriformis muscle injection, Trochanteric bursa injection, Hip/knee joint injections, Medial branch block (innervates facet joint), Pulsed radiofrequency neurotomy medial branches, Pulsed radiofrequency dorsal root ganglion, Thermal (high temperature) radiofrequency neurotomy medial branches, Trigger point injections, and Botulinum toxin injections) involving the spine within the past 30 days
- Have any condition that is likely to confound evaluation of study endpoints. Conditions that may make paresthesia coverage variable over the course of the study include multiple sclerosis, partial spinal cord injury, diabetic peripheral neuropathy, peripheral vascular disease, scoliosis, deafferentation, etc.
Sites / Locations
- University of California, San Diego Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Spinal Cord Stimulation Group
Arm Description
Spinal Cord Stimulation (SCS) Treatment Group
Outcomes
Primary Outcome Measures
Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm)
Secondary Outcome Measures
Full Information
NCT ID
NCT00871819
First Posted
March 27, 2009
Last Updated
November 5, 2013
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00871819
Brief Title
Optimized Programming in Spinal Cord Stimulation (SCS) System
Acronym
OP
Official Title
Optimized Programming in a Multiple-Independent Current Sources Spinal Cord Stimulation (SCS) System
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate extent, location, and perception of paresthesia as a function of anode/cathode configuration.
Detailed Description
The clinical results from this study may help to validate predictions made by mathematical models of neurons that are activated by SCS and increase scientific knowledge about the way in which different programs relate to satisfactory outcomes, such that use of the model may help in the development of new products.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Pain
Keywords
Spinal Cord Stimulation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal Cord Stimulation Group
Arm Type
Other
Arm Description
Spinal Cord Stimulation (SCS) Treatment Group
Intervention Type
Device
Intervention Name(s)
Precision Spinal Cord Stimulation (SCS)
Other Intervention Name(s)
Precision Spinal Cord Stimulation System
Intervention Description
Various SCS device programming parameters
Primary Outcome Measure Information:
Title
Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm)
Time Frame
Immediately post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be previously implanted with Precision SCS System (3-36 months post permanent implant) having 2 parallel percutaneous leads placed between T8-T10.
Be implanted with Precision SCS System for the treatment of neuropathic pain of trunk and/or limbs
Be 18 years of age or older
Be extremely satisfied, very satisfied, or satisfied with SCS therapy for treatment of pain condition
Be able to use pen tablet to document regions of paresthesia and pain
Be able to lie in the supine position for 45 minutes at a minimum
Be able to verbally report qualitative and quantitative aspects of paresthesia sensations.
Have a paresthesia threshold on a standard program below 4mA while in the supine position
Have at minimum the upper contact of one lead below T8 and the lower contact above T11 vertebral levels
Be willing and able to comply with study-related procedure
Agree to study requirements and provides written Informed Consent
Exclusion Criteria:
Unable to read, write, speak, and understand English
Currently pregnant or planning to become pregnant during the course of the study
Have negative finding in any of the pre-screening and screening requirements
Upon fluoroscopy, location of both leads is identified to be outside T8-T10 vertebral levels
Unable to perceive the sensation of paresthesia associated with stimulation in the trunk and/or lower extremities
Have a drug pump and/or a non-Precision neurostimulation device (regardless of whether active or inactive)
Have had any interventional pain procedure or surgeries (including Interlaminar epidural steroid injection, Transforaminal epidural steroid injection, Caudal epidural steroid injection, Selective nerve root block, Intraarticular lumbar facet injection, Sacroiliac joint injection, Piriformis muscle injection, Trochanteric bursa injection, Hip/knee joint injections, Medial branch block (innervates facet joint), Pulsed radiofrequency neurotomy medial branches, Pulsed radiofrequency dorsal root ganglion, Thermal (high temperature) radiofrequency neurotomy medial branches, Trigger point injections, and Botulinum toxin injections) involving the spine within the past 30 days
Have any condition that is likely to confound evaluation of study endpoints. Conditions that may make paresthesia coverage variable over the course of the study include multiple sclerosis, partial spinal cord injury, diabetic peripheral neuropathy, peripheral vascular disease, scoliosis, deafferentation, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Kormylo, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
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Optimized Programming in Spinal Cord Stimulation (SCS) System
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