The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain
A Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain
2 other identifiers
interventional
230
1 country
18
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Jun 2020
Longer than P75 for not_applicable low-back-pain
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2019
CompletedFirst Posted
Study publicly available on registry
January 29, 2020
CompletedStudy Start
First participant enrolled
June 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
ExpectedApril 13, 2026
December 1, 2025
5.8 years
December 19, 2019
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (17)
Reduction in average pain intensity
Average pain is measured using question 5 from the Brief Pain Inventory- Short Form (BPI-5). BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain.
Up to 3-months after Start of Therapy (SOT)
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
During the Medial Branch Block procedure
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
During the Lead Placement procedure (SOT)
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
1-week post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
2-weeks post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
3-weeks post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
4-weeks post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
5-weeks post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
6-weeks post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
7-weeks post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
8-weeks post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
3-months post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
6-months post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
9-months post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
12-months post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
18-months post-SOT
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
24-months post-SOT
Secondary Outcomes (7)
Reduction in pain interference
Baseline, 3-months after SOT
Reduction in disability
Baseline, 3-months after SOT
Durability of reductions in pain intensity
Baseline, 6-months after SOT, 9-months after SOT, 12-months after SOT, 18-months after SOT, 24 months after SOT
Reduction in worst pain intensity
Baseline, 3-months after SOT
Patient Global Impression of Change
3-months after SOT
- +2 more secondary outcomes
Study Arms (2)
Group 1: Peripheral Nerve Stimulation (PNS)
ACTIVE COMPARATORSubjects 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.
Group 2: Standard Interventional Management (Standard of Care)
ACTIVE COMPARATORSubjects 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).
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- Chronic low back pain
You may not qualify if:
- Body Mass Index (BMI) \> 40
- Prior lumbar surgery
- Implanted electronic device
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SPR Therapeutics, Inc.lead
- United States Department of Defensecollaborator
Study Sites (18)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
IPM Medical Group
Walnut Creek, California, 94598, United States
Denver Back Pain Specialists
Greenwood Village, Colorado, 80111, United States
International Spine, Pain & Performance Center
Washington D.C., District of Columbia, 20006, United States
Emory University
Atlanta, Georgia, 30329, United States
Northwest Speciality Hospital
Post Falls, Idaho, 83854, United States
Millennium Pain Center
Bloomington, Illinois, 61704, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Premier Pain Centers
Shrewsbury, New Jersey, 07702, United States
Duke University
Durham, North Carolina, 27710, United States
Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Main Line Spine
King of Prussia, Pennsylvania, 19406, United States
Institute of Precision Pain Medicine
Corpus Christi, Texas, 78414, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Virginia iSpine Physicians
Richmond, Virginia, 23235, United States
Hunter Holmes McGuire Veterans Affairs Medical Center
Richmond, Virginia, 23249, United States
Spine and Nerve Center of St. Francis Hospital
Charleston, West Virginia, 25301, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2019
First Posted
January 29, 2020
Study Start
June 17, 2020
Primary Completion
April 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
April 13, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share