search
Back to results

A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes (COVERAGE)

Primary Purpose

Chronic Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conventional single source programming
Precision Spectra SCS System advanced programming
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pain focused on measuring stimulation, implantable, pulse generator, back pain, chronic pain, leg pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meets RELIEF Registry criteria for inclusion
  • Primary complaint of persistent or recurrent low back pain, with or without leg pain
  • Signed a valid, IRB/EC-approved informed consent form

Exclusion Criteria:

  • Meets any RELIEF Registry criteria for exclusion

Sites / Locations

  • Physicians Research Group, LLC
  • Albany Medical Center
  • PCPMG Clinical Research Unit, LLC
  • Spine Team Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional Programming, then Advanced Programming

Advanced Programming, then Conventional Programming

Arm Description

Precision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received conventional single source programming followed by Precision Spectra SCS System advanced programming.

Precision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received Precision Spectra SCS System advanced programming followed by conventional single source programming.

Outcomes

Primary Outcome Measures

Number of Participants With Paresthesia Coverage ≥50%
Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2015
Last Updated
November 18, 2020
Sponsor
Boston Scientific Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT02384096
Brief Title
A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes
Acronym
COVERAGE
Official Title
COVERAGE - A Study to Evaluate the Effect of Precision Spectra™ SCS System's Programming Features and Lead Options on Patient Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (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 study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming features and lead options.
Detailed Description
The study is a sub-study of RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (NCT01719055). The treatment will consist of permanent implant of a Precision Spectra™ SCS IPG with either a 32 contact CoverEdge™ Surgical Lead or with more than 2 percutaneous leads after a successful trial. Programming features and lead options of the Precision Spectra™ SCS System will be evaluated up to 3 months post-IPG activation. Following completion of the 3 month visit, subjects will continue to be followed for up to 36 months per the study requirements of the RELIEF Registry.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
stimulation, implantable, pulse generator, back pain, chronic pain, leg pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Programming, then Advanced Programming
Arm Type
Active Comparator
Arm Description
Precision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received conventional single source programming followed by Precision Spectra SCS System advanced programming.
Arm Title
Advanced Programming, then Conventional Programming
Arm Type
Active Comparator
Arm Description
Precision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received Precision Spectra SCS System advanced programming followed by conventional single source programming.
Intervention Type
Device
Intervention Name(s)
Conventional single source programming
Intervention Description
Precision Spectra SCS System using conventional single source programming.
Intervention Type
Device
Intervention Name(s)
Precision Spectra SCS System advanced programming
Intervention Description
Precision Spectra SCS System using advanced programming
Primary Outcome Measure Information:
Title
Number of Participants With Paresthesia Coverage ≥50%
Description
Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported.
Time Frame
7, 14 days post activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets RELIEF Registry criteria for inclusion Primary complaint of persistent or recurrent low back pain, with or without leg pain Signed a valid, IRB/EC-approved informed consent form Exclusion Criteria: Meets any RELIEF Registry criteria for exclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Lechleiter, M.S.
Organizational Affiliation
Boston Scientific Neuromodulation Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Physicians Research Group, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
PCPMG Clinical Research Unit, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Spine Team Texas
City
Rockwall
State/Province
Texas
ZIP/Postal Code
75032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes

We'll reach out to this number within 24 hrs