The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain

May 22, 2026 updated by: SPR Therapeutics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Study-Related Adverse Events (AEs)
Time Frame: During the Lead Placement procedure (SOT)
Occurrence and type of study-related AEs
During the Lead Placement procedure (SOT)
Study-Related Adverse Events (AEs)
Time Frame: 1-week post-SOT
Occurrence and type of study-related AEs
1-week post-SOT
Study-Related Adverse Events (AEs)
Time Frame: 2-weeks post-SOT
Occurrence and type of study-related AEs
2-weeks post-SOT
Study-Related Adverse Events (AEs)
Time Frame: 3-weeks post-SOT
Occurrence and type of study-related AEs
3-weeks post-SOT
Study-Related Adverse Events (AEs)
Time Frame: 4-weeks post-SOT
Occurrence and type of study-related AEs
4-weeks post-SOT
Study-Related Adverse Events (AEs)
Time Frame: 5-weeks post-SOT
Occurrence and type of study-related AEs
5-weeks post-SOT
Study-Related Adverse Events (AEs)
Time Frame: 6-weeks post-SOT
Occurrence and type of study-related AEs
6-weeks post-SOT
Study-Related Adverse Events (AEs)
Time Frame: 7-weeks post-SOT
Occurrence and type of study-related AEs
7-weeks post-SOT
Study-Related Adverse Events (AEs)
Time Frame: 8-weeks post-SOT
Occurrence and type of study-related AEs
8-weeks post-SOT
Study-Related Adverse Events (AEs)
Time Frame: 3-months post-SOT
Occurrence and type of study-related AEs
3-months post-SOT
Study-Related Adverse Events (AEs)
Time Frame: 6-months post-SOT
Occurrence and type of study-related AEs
6-months post-SOT
Study-Related Adverse Events (AEs)
Time Frame: 9-months post-SOT
Occurrence and type of study-related AEs
9-months post-SOT
Study-Related Adverse Events (AEs)
Time Frame: 12-months post-SOT
Occurrence and type of study-related AEs
12-months post-SOT
Study-Related Adverse Events (AEs)
Time Frame: 18-months post-SOT
Occurrence and type of study-related AEs
18-months post-SOT
Study-Related Adverse Events (AEs)
Time Frame: 24-months post-SOT
Occurrence and type of study-related AEs
24-months post-SOT
Reduction in average pain intensity
Time Frame: Up to 3-months after Start of Therapy (SOT)
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)
Time Frame: During the Medial Branch Block procedure
Occurrence and type of study-related AEs
During the Medial Branch Block procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reduction in pain interference
Time Frame: Baseline, 3-months after SOT
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
Time Frame: Baseline, 3-months after SOT
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
Time Frame: Baseline, 6-months after SOT, 9-months after SOT, 12-months after SOT, 18-months after SOT, 24 months after SOT
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
Time Frame: Baseline, 3-months after SOT
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
Time Frame: 3-months after SOT
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
Time Frame: Baseline, 3-months after SOT
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
Time Frame: Baseline, 3-months after SOT
Analgesic medication consumption will be collected.
Baseline, 3-months after SOT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SPR Therapeutics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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