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

Chronic Pain Clinical Trial

— COVERAGE  

Official title:

COVERAGE - A Study to Evaluate the Effect of Precision Spectra™ SCS System's Programming Features and Lead Options on Patient Outcomes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02384096
• Other study ID #: 90968587
• Status: Terminated
• Phase: N/A
• Start date: February 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Conventional single source programming
Precision Spectra SCS System using conventional single source programming.
• Precision Spectra SCS System advanced programming
Precision Spectra SCS System using advanced programming

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	PCPMG Clinical Research Unit, LLC	Greenville	South Carolina
United States	Physicians Research Group, LLC	Phoenix	Arizona
United States	Spine Team Texas	Rockwall	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7, 14 days post activation