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

SPR Therapeutics

Status: Active, not recruiting

Conditions: Back Pain; Low Back Pain

Treatments: Device: SPRINT Peripheral Nerve Stimulation (PNS) System; Procedure: Standard interventional management of low back pain

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT04246281

CDMRP-PR170708 (Other Grant/Funding Number)

0151-CSP-000

Details and patient eligibility

About

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)

Enrollment: 230 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Chronic low back pain

Key Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Group 1: Peripheral Nerve Stimulation (PNS)

Active Comparator group

Description:

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.

Treatment:

Device: SPRINT Peripheral Nerve Stimulation (PNS) System

Group 2: Standard Interventional Management (Standard of Care)

Active Comparator group

Description:

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).

Treatment:

Procedure: Standard interventional management of low back pain