The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain
NCT ID: NCT04246281
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
230 participants
INTERVENTIONAL
2020-06-17
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Shoulder Osteoarthritis
NCT05657587
Peripheral Nerve Stimulation With the SPRINT® System in Chronic PSIJC Pain
NCT07166952
The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain
NCT03783689
Retrospective PNS Study
NCT06832449
BurstDR Stimulation for Painful Diabetic Neuropathy
NCT05985291
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1: Peripheral Nerve Stimulation (PNS)
Subjects in Group 1 will have leads placed in their lower back. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.
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).
Group 2: Standard Interventional Management (Standard of Care)
Subjects in Group 2 will receive the standard of care. Group 2 subjects may be able to crossover to receive PNS after 12 months from start of treatment (Visit 16).
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Prior lumbar surgery
* Implanted electronic device
* Pregnant
21 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
United States Department of Defense
FED
SPR Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Related Links
Access external resources that provide additional context or updates about the study.
Sponsor's Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDMRP-PR170708
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
0151-CSP-000
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.