Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Pragmatic Clinical Trial

NACompletedINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

January 26, 2021

Primary Completion Date

February 1, 2025

Study Completion Date

September 22, 2025

Conditions
Rotator Cuff RepairAnkle Arthroplasty or ArthrodesisHallux Valgus (Bunion) Resection
Interventions
DEVICE

Peripheral Nerve Stimulation

ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electric current for 14 days

DEVICE

Sham

SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that does not generate electric current for 14 days

Trial Locations (6)

20889

Walter Reed National Military Medical Center, Bethesda

28310

Womack Army Medical Center, Fort Bragg

44195

Cleveland Clinic, Cleveland

90048

Cedars- Sinai Medical Center, Los Angeles

92103

University of California, San Diego, San Diego

92134

Naval Medical Center San Diego, San Diego

All Listed Sponsors
collaborator

Congressionally Directed Medical Research Programs

FED

lead

University of California, San Diego

OTHER

NCT04713098 - Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Pragmatic Clinical Trial | Biotech Hunter | Biotech Hunter