Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude (WHISPER)

Boston Scientific

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Precision or Precision Spectra Spinal Cord Stimulator System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02314000

90987574 (Other Identifier)

A4046

Details and patient eligibility

About

To demonstrate sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude

Full description

To demonstrate sustained clinically significant pain relief in patients when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude

Enrollment: 229 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Complaint of chronic pain of the trunk and/or limbs
2. Willing and able to comply with all protocol-required procedures and assessments/evaluations; able to independently read and complete all questionnaires and assessments provided in English
3. Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

1. Meets any contraindication in the Precision SCS system per locally applicable Directions for Use (DFU)
2. Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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229 participants in 2 patient groups

SCS starting with supra-perception

Active Comparator group

Description:

Precision or Precision Spectra Spinal Cord Stimulator System programmed at supra-perception followed by sub-perception SCS

Treatment:

Device: Precision or Precision Spectra Spinal Cord Stimulator System

SCS starting with sub-perception amplitude

Experimental group

Description:

Precision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception followed by supra-perception SCS

Treatment:

Device: Precision or Precision Spectra Spinal Cord Stimulator System