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

Boston Scientific Corporation229 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

229

Conditions

Chronic Pain

Interventions

Precision or Precision Spectra Spinal Cord Stimulator SystemDEVICE

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (26)

Outcomes

Primary Outcomes

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

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

Time frame: 90 days post activation

Data from ClinicalTrials.gov

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