Phase 4 N=20 Double-blind Supportive Care

Optimized Programming in Spinal Cord Stimulation (SCS) System

Neuropathic Pain · Pain

Bottom Line

View on ClinicalTrials.gov: NCT00871819 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2012

Primary outcome: Primary: Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm) — 0.6202 Correlation coefficient

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Precision Spinal Cord Stimulation (SCS) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boston Scientific Corporation
Primary completion: Aug 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm)	0.6202	—

Summary

The objective of this study is to evaluate extent, location, and perception of paresthesia as a function of anode/cathode configuration.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00871819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.