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

NCT04246281 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-04-13

No results posted yet for this study

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)

Conditions

Interventions

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).

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • SPR Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-17
Primary Completion
2026-04-30
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04246281 on ClinicalTrials.gov