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

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

Completed

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MORE Foundation, Phoenix, Arizona, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

Complaint of chronic pain of the trunk and/or limbs
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
Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

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

Treatment and study plan

Precision or Precision Spectra Spinal Cord Stimulator System

Device

Primary outcomes

Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline

Time frame: 90 days post activation

Proportion of subjects with 50% or greater reduction in overall pain intensity from baseline with supra and sub perception amplitude with no increase in average daily medication intake to treat pain

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

WHISPER - A Randomized Controlled Study to Evaluate the Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude

Acronym: WHISPER

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2018
First posted: Dec 10, 2014
Registry last updated: Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed