Back to resultsStudy to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Programming
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Pain focused on measuring stimulation, chronic pain, back pain, leg pain
Eligibility Criteria
Key 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).
Sites / Locations
- Pacific Pain Management, Inc.
- PCPMG Clinical Research Unit, LLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spinal cord stimulation
Arm Description
Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
Outcomes
Primary Outcome Measures
Patient Comfort
Number of participants reporting comfort level of stimulation sensation as "Very Comfortable" or "Slightly Comfortable"
Secondary Outcome Measures
Full Information
NCT ID
NCT02988713
First Posted
November 29, 2016
Last Updated
April 14, 2022
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02988713
Brief Title
Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial
Official Title
Study to Characterize the Effects of Programming Spinal Cord Stimulation (SCS) in Patients Undergoing a Boston Scientific (BSC) SCS Temporary Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 13, 2016 (Actual)
Primary Completion Date
December 2, 2020 (Actual)
Study Completion Date
December 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
stimulation, chronic pain, back pain, leg pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal cord stimulation
Arm Type
Experimental
Arm Description
Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
Intervention Type
Device
Intervention Name(s)
Programming
Intervention Description
Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
Primary Outcome Measure Information:
Title
Patient Comfort
Description
Number of participants reporting comfort level of stimulation sensation as "Very Comfortable" or "Slightly Comfortable"
Time Frame
An estimated average of 7 days post temporary trial procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshini Jain, M.S.
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Pain Management, Inc.
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
PCPMG Clinical Research Unit, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial
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