Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Multicenter Pilot Study

NACompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

July 14, 2018

Primary Completion Date

September 11, 2020

Study Completion Date

January 7, 2021

Conditions
Rotator Cuff RepairAnterior Cruciate Ligament ReconstructionAnkle Arthrodesis or ArthroplastyHallux Valgus Correction
Interventions
DEVICE

ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio)

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 peripheral nerve stimulation with a percutaneously inserted lead and wearable SHAM stimulator (SPR Therapeutics, Cleveland, Ohio)

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

78234

Brooke Army Medical Center, Fort Sam Houston

92103

University California San Diego, San Diego

92134

Naval Medical Center San Diego, San Diego

All Listed Sponsors
collaborator

Uniformed Services University of the Health Sciences

FED

collaborator

Walter Reed National Military Medical Center

FED

collaborator

Wake Forest University Health Sciences

OTHER

collaborator

Augusta University

OTHER

collaborator

The Cleveland Clinic

OTHER

collaborator

Brooke Army Medical Center

FED

collaborator

United States Naval Medical Center, San Diego

FED

collaborator

VA Palo Alto Health Care System

FED

collaborator

Womack Army Medical Center

FED

collaborator

SPR Therapeutics, Inc.

INDUSTRY

lead

University of California, San Diego

OTHER

NCT03481725 - Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Multicenter Pilot Study | Biotech Hunter | Biotech Hunter