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

Boston Scientific

Status: Terminated

Conditions: Chronic Pain

Treatments: Device: Precision Spectra SCS System advanced programming; Device: Conventional single source programming

Study type: Interventional

Funder types: Industry

Identifiers

NCT02384096

90968587

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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17 participants in 2 patient groups

Conventional Programming, then Advanced Programming

Active Comparator group

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.

Treatment:

Device: Precision Spectra SCS System advanced programming

Device: Conventional single source programming

Advanced Programming, then Conventional Programming

Active Comparator group

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.

Treatment:

Device: Precision Spectra SCS System advanced programming

Device: Conventional single source programming