Safety and Effectiveness Study of the Precision SCS Systems Adapted for High-Rate Spinal Cord Stimulation

Completed · Not applicable

Conditions studied: Chronic Pain, Back Pain

In brief

To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain

Key facts

Study ID

NCT02093793

Run by

Boston Scientific Corporation

People needed

383

Starts

2014-03-27

Expected to finish

2019-08-29

Last updated by the study team

2020-11-13

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have been diagnosed with chronic, intractable pain of the trunk (NRS ≥ 5) which has been refractory to conservative therapy for a minimum of 90 days.
• Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
• Be 22 years of age or older at the time of enrollment
• Be willing and capable of giving informed consent
• Be willing and able to comply with study-related requirements, procedures, and visits

You may not qualify if…

• Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
• Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
• Have previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
• Have a current systemic infection, or local infection in close proximity to anticipated surgical field
• Pregnant or plan to get pregnant during the course of the study or not using adequate contraception.
• Be participating in another clinical study that may influence the data collected for the study

Where it is running

• Hope Research Institute — Phoenix, Arizona, United States
• Coastal Pain & Spinal Diagnostics — Carlsbad, California, United States
• UCSD Medical Center - Jacobs Medical Center — La Jolla, California, United States
• San Diego Pain Institute — San Diego, California, United States
• Compass Research, LLC — Orlando, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Willis-Knighton River Cities Clinical Research Center — Shreveport, Louisiana, United States
• MAPS Applied Research Center — Edina, Minnesota, United States
• Mayo Clinic Foundation — Rochester, Minnesota, United States
• Mercy Medical Research Institute — Springfield, Missouri, United States
• Hope Research Institute — Las Vegas, Nevada, United States
• Premier Pain Centers, LLC — Shrewsbury, New Jersey, United States
• The Center for Clinical Research, LLC — Winston-Salem, North Carolina, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Pacific Sports and Spine, LLC — Eugene, Oregon, United States
• Pain Consultants of Oregon — Eugene, Oregon, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Oregon Neurosurgery — Springfield, Oregon, United States
• Precision Spine Care — Tyler, Texas, United States
• Pacific Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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