Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial

Boston Scientific Corporation35 enrolled

Overview

This is a prospective, multi-center, non-randomized, exploratory, single-arm study characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Chronic Pain

Interventions

ProgrammingDEVICE

Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Study candidate is undergoing a spinal cord stimulation (SCS) trial of BSC neurostimulation system, per local directions for use (DFU). * Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form. * Subject is 18 years of age or older when written informed consent is obtained. Key Exclusion Criteria: * Subject meets any contraindication in BSC neurostimulation system local directions for use (DFU).

Locations (2)

Pacific Pain Management, Inc.

Ventura, California, United States

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, United States

Outcomes

Primary Outcomes

Patient Comfort

Number of participants reporting comfort level of stimulation sensation as "Very Comfortable" or "Slightly Comfortable"

Time frame: An estimated average of 7 days post temporary trial procedure

Data from ClinicalTrials.gov

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