Peripheral Nerve Stimulation for Shoulder Pain: Dose Response

NACompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

August 31, 2019

Study Completion Date

October 30, 2019

Conditions
StrokeShoulder Pain
Interventions
DEVICE

Peripheral Nerve Stimulation

The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for PNS. The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (daily dose is Group-dependent). Stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed. Total time of electrode implantation is no more than 29 days.

Trial Locations (1)

44109

MetroHealth Medical Center, Cleveland

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

Case Western Reserve University

OTHER

lead

MetroHealth Medical Center

OTHER

NCT02928055 - Peripheral Nerve Stimulation for Shoulder Pain: Dose Response | Biotech Hunter | Biotech Hunter