NCT04246281

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: SPR Therapeutics, Inc. · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Low Back Pain
• Back Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-17
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2020-01-29
• Last updated: 2026-04-13

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated device study