Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial
Not Applicable
Completed
- Conditions
- Chronic Pain
- Interventions
- Device: Programming
- Registration Number
- NCT02988713
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
This is a prospective, multi-center, non-randomized, exploratory, single-arm study characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- Study candidate is undergoing a spinal cord stimulation (SCS) trial of BSC neurostimulation system, per local directions for use (DFU).
- Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
- Subject is 18 years of age or older when written informed consent is obtained.
Key
Exclusion Criteria
- Subject meets any contraindication in BSC neurostimulation system local directions for use (DFU).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Spinal cord stimulation Programming Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
- Primary Outcome Measures
Name Time Method Patient Comfort An estimated average of 7 days post temporary trial procedure Number of participants reporting comfort level of stimulation sensation as "Very Comfortable" or "Slightly Comfortable"
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Pacific Pain Management, Inc.
🇺🇸Ventura, California, United States
PCPMG Clinical Research Unit, LLC
🇺🇸Greenville, South Carolina, United States
Pacific Pain Management, Inc.🇺🇸Ventura, California, United States