Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)

NACompletedINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

March 1, 2019

Primary Completion Date

June 21, 2024

Study Completion Date

June 21, 2024

Conditions
Shoulder PainShoulder Impingement SyndromeShoulder TendinitisShoulder BursitisPain, Shoulder
Interventions
DEVICE

Contracting Producing 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 Peripheral Nerve Stimulation (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 The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip.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 (6 hrs/day). The duty cycle and daily dose remain constant, but 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.

DEVICE

Non Contracting Producing 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 Peripheral Nerve Stimulation (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 The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip.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 (6 hrs/day). The duty cycle and daily dose remain constant, but 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.

OTHER

Physical Therapy

All participants receive eight 1.0 hr. sessions of physical therapy (PT) over a 4-wk period from a therapist blinded to Peripheral Nerve Stimulation (PNS) treatment assignment. Each participant also performs home exercises. The primary objective of physical therapy (PT) and the home exercise program is to prevent re-injury by educating and training participants in the biomechanics and proper use of the shoulder and upper limb. During each in-lab session, participants are trained in the implementation of these exercises, which are individually adjusted and progressed with increasing external loads by using weights and elastic rubber bands.

Trial Locations (2)

44109

MetroHealth Medical Center, Cleveland

75390

Univerity of Texas Southwestern, Dallas

All Listed Sponsors
collaborator

University of Texas

OTHER

lead

MetroHealth Medical Center

OTHER

NCT03752619 - Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS) | Biotech Hunter | Biotech Hunter