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

NCT ID: NCT02384096

Last Updated: 2020-11-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Chronic Pain

Keywords

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stimulation implantable pulse generator back pain chronic pain leg pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional Programming, then 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.

Group Type ACTIVE_COMPARATOR

Conventional single source programming

Intervention Type DEVICE

Precision Spectra SCS System using conventional single source programming.

Precision Spectra SCS System advanced programming

Intervention Type DEVICE

Precision Spectra SCS System using advanced programming

Advanced Programming, then Conventional 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.

Group Type ACTIVE_COMPARATOR

Conventional single source programming

Intervention Type DEVICE

Precision Spectra SCS System using conventional single source programming.

Precision Spectra SCS System advanced programming

Intervention Type DEVICE

Precision Spectra SCS System using advanced programming

Interventions

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Conventional single source programming

Precision Spectra SCS System using conventional single source programming.

Intervention Type DEVICE

Precision Spectra SCS System advanced programming

Precision Spectra SCS System using advanced programming

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristen Lechleiter, M.S.

Role: STUDY_DIRECTOR

Boston Scientific Neuromodulation Corporation

Locations

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Physicians Research Group, LLC

Phoenix, Arizona, United States

Site Status

Albany Medical Center

Albany, New York, United States

Site Status

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, United States

Site Status

Spine Team Texas

Rockwall, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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90968587

Identifier Type: -

Identifier Source: org_study_id