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The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain
Sponsor: SPR Therapeutics, Inc.
Summary
The purpose of this study is to compare standard of care treatments for back pain to electrical stimulation. Stimulation is delivering small amounts of electricity to the nerves in your low back. This study will use a device called the SPRINT Peripheral Nerve Stimulation (PNS) System. The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain (including back pain)
Official title: A Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain
Key Details
Gender
All
Age Range
21 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
230
Start Date
2020-06-17
Completion Date
2027-04
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
SPRINT Peripheral Nerve Stimulation (PNS) System
The SPRINT System delivers mild electrical stimulation to the nerves in your low back. The SPRINT System includes up to two leads (small wires) that are placed through your skin into your low back. The leads attach to devices worn on your body that deliver stimulation (called Stimulators).
Standard interventional management of low back pain
Your doctor will determine which procedure or intervention is appropriate for your back pain. You may receive radiofrequency ablation, spinal cord stimulation, surgery, or another procedure or treatment, as appropriate.
Locations (18)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
IPM Medical Group
Walnut Creek, California, United States
Denver Back Pain Specialists
Greenwood Village, Colorado, United States
International Spine, Pain & Performance Center
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Northwest Speciality Hospital
Post Falls, Idaho, United States
Millennium Pain Center
Bloomington, Illinois, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Premier Pain Centers
Shrewsbury, New Jersey, United States
Duke University
Durham, North Carolina, United States
Center for Clinical Research
Winston-Salem, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Main Line Spine
King of Prussia, Pennsylvania, United States
Institute of Precision Pain Medicine
Corpus Christi, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Virginia iSpine Physicians
Richmond, Virginia, United States
Hunter Holmes McGuire Veterans Affairs Medical Center
Richmond, Virginia, United States
Spine and Nerve Center of St. Francis Hospital
Charleston, West Virginia, United States