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

Not Applicable

Terminated

• Conditions: Chronic Pain
• Interventions: Device: Conventional single source programming; Device: Precision Spectra SCS System advanced programming

• Registration Number: NCT02384096
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study First Submitted: 2015-01-28
• Study Start: 2015-02
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2017-10-13
• Results First Submitted QC: 2018-07-17
• Results First Posted: 2018-07-19
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Advanced Programming, then Conventional Programming	Conventional single source 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.
Advanced Programming, then Conventional Programming	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.
Conventional Programming, then Advanced Programming	Precision Spectra SCS System advanced programming	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.
Conventional Programming, then Advanced Programming	Conventional single source programming	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Paresthesia Coverage ≥50%	7, 14 days post activation	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.

Trial Locations

Locations (4)

Physicians Research Group, LLC; 🇺🇸 Phoenix, Arizona, United States

Albany Medical Center; 🇺🇸 Albany, New York, United States

PCPMG Clinical Research Unit, LLC; 🇺🇸 Greenville, South Carolina, United States

Spine Team Texas; 🇺🇸 Rockwall, Texas, United States