Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System

Not Applicable

Completed

• Conditions: Chronic Pain; Back Pain
• Interventions: Device: Spectra WaveWriter SCS System

• Registration Number: NCT03251937
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

To demonstrate the value of multiple modalities and sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Spectra WaveWriter Spinal Cord Stimulator (SCS) System.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-16
• Study Start: 2018-01-09
• Primary Completion: 2019-01-09
• Results First Submitted: 2020-01-21
• Results First Submitted QC: 2020-03-02
• Study Completion: 2020-03-10
• Results First Posted: 2020-03-16
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Chronic pain of the trunk and/or limbs
• 22 years of age or older at time of enrollment
• Willing and able to comply with all protocol-required procedures and assessments/evaluations provided in English
• Willing and capable of giving informed consent

Key

Exclusion Criteria

• Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
• Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
• Current systemic infection, or local infection in close proximity to the anticipated surgical field
• Breast-feeding, pregnant or planning to get pregnant during the course of the study or not using adequate contraception
• Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
• Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal Cord Stimulation	Spectra WaveWriter SCS System	Spectra WaveWriter SCS System

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline	3 months post activation

Trial Locations

Locations (15)

Mercy Medical Research Institute; 🇺🇸 Springfield, Missouri, United States

University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

Neurovations; 🇺🇸 Napa, California, United States

Louis J. Raso, MD, PA; 🇺🇸 Jupiter, Florida, United States

Florida Pain Clinic; 🇺🇸 Ocala, Florida, United States

Forest Health Medical Center; 🇺🇸 Ypsilanti, Michigan, United States

The Center for Clinical Research, LLC; 🇺🇸 Winston-Salem, North Carolina, United States

Western Reserve Spine and Pain Institute; 🇺🇸 Kent, Ohio, United States

Pacific Sports and Spine, LLC; 🇺🇸 Eugene, Oregon, United States

Toledo Clinic; 🇺🇸 Toledo, Ohio, United States

West Chester Hospital, LLC; 🇺🇸 West Chester, Ohio, United States

Spine Team Texas; 🇺🇸 Rockwall, Texas, United States

Swedish Neuroscience Institute; 🇺🇸 Seattle, Washington, United States

Advanced Pain Management Appleton; 🇺🇸 Appleton, Wisconsin, United States