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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Back Pain; Low Back Pain
• Intervention / Treatment: Device: SPRINT Peripheral Nerve Stimulation (PNS) System; Procedure: Standard interventional management of low back pain

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Walnut Creek, California, United States, 94598
      • IPM Medical Group
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Denver Back Pain Specialists
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20006
      • International Spine, Pain & Performance Center
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University
  • Idaho
    • Post Falls, Idaho, United States, 83854
      • Northwest Speciality Hospital
  • Illinois
    • Bloomington, Illinois, United States, 61704
      • Millennium Pain Center
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
  • New Jersey
    • Shrewsbury, New Jersey, United States, 07702
      • Premier Pain Centers
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Winston-Salem, North Carolina, United States, 27103
      • Center for Clinical Research
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Pennsylvania
    • King of Prussia, Pennsylvania, United States, 19406
      • Main Line Spine
  • Texas
    • Corpus Christi, Texas, United States, 78414
      • Institute of Precision Pain Medicine
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes McGuire Veterans Affairs Medical Center
    • Richmond, Virginia, United States, 23235
      • Virginia iSpine Physicians
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • Spine and Nerve Center of St. Francis Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Chronic low back pain

Key Exclusion Criteria:

• Body Mass Index (BMI) > 40
• Prior lumbar surgery
• Implanted electronic device
• Pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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).
Active Comparator: 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).	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in pain interference	Measured using question 9 from the Brief Pain Inventory- Short Form. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is "does not interfere" and 10 is "completely interferes" within the last week.	Baseline, 3-months after SOT
Reduction in disability	Measured using the Oswestry Disability Index (ODI). The ODI asks subjects to rate how their back pain impacts ten components of everyday life. For each section, the answers correlate to a scale which ranges from 0 to 5, where 0 is no disability and 5 is maximum disability.	Baseline, 3-months after SOT
Durability of reductions in pain intensity	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.	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	Measured using question 3 from the Brief Pain Inventory- Short Form (BPI-3). BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain.	Baseline, 3-months after SOT
Patient Global Impression of Change	Measured using the Patient Global Impression of Change (PGIC) survey. The PGIC scale asks subjects to rate their improvement with treatment on a 7-point scale (centered at 4) that ranges from "very much worse" to "very much improved" relative to baseline.	3-months after SOT
Change in health-related quality of life	Measured using the EQ-5D survey. The EQ-5D is a five-level scale. Each level is coded from 1 to 5, where 1 indicates no problems and 5 indicates extreme problems. The EQ-5D also includes a 0 to 100 scale for health status, where 0 indicates "the worst health you can imagine" and 100 indicates "the best health you can imagine".	Baseline, 3-months after SOT
Change in analgesic medication usage	Analgesic medication consumption will be collected.	Baseline, 3-months after SOT

Collaborators and Investigators

• Sponsor: SPR Therapeutics, Inc.
• Collaborators: United States Department of Defense

Publications and helpful links

Helpful Links

• Sponsor's Website

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2020
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Neuromodulation; Electrical Stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Low Back Pain; Therapeutics; Drug Therapy; Drug Delivery Systems
• Other Study ID Numbers: 0151-CSP-000; CDMRP-PR170708 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No