Optimized Programming in Spinal Cord Stimulation (SCS) System (OP)
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ClinicalTrials.gov Identifier: NCT00871819 |
Recruitment Status :
Completed
First Posted : March 30, 2009
Results First Posted : April 4, 2012
Last Update Posted : November 27, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuropathic Pain Pain | Device: Precision Spinal Cord Stimulation (SCS) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Supportive Care |
Official Title: | Optimized Programming in a Multiple-Independent Current Sources Spinal Cord Stimulation (SCS) System |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | September 2009 |
Arm | Intervention/treatment |
---|---|
Spinal Cord Stimulation Group
Spinal Cord Stimulation (SCS) Treatment Group
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Device: Precision Spinal Cord Stimulation (SCS)
Various SCS device programming parameters
Other Name: Precision Spinal Cord Stimulation System |
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871819
United States, California | |
University of California, San Diego Medical Center | |
San Diego, California, United States, 92037 |
Principal Investigator: | Nicholas Kormylo, MD | University of California, San Diego |
Responsible Party: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00871819 |
Other Study ID Numbers: |
A2008 |
First Posted: | March 30, 2009 Key Record Dates |
Results First Posted: | April 4, 2012 |
Last Update Posted: | November 27, 2013 |
Last Verified: | November 2013 |
Spinal Cord Stimulation |
Neuralgia Peripheral Nervous System Diseases Neuromuscular Diseases |
Nervous System Diseases Pain Neurologic Manifestations |