Treatment of Shoulder Osteoarthritis

Gramercy Pain Center

Status: Enrolling

Conditions: Chronic Shoulder Pain

Treatments: Device: SPRINT PNS

Study type: Observational

Funder types: Other

Identifiers

NCT05657587

0001

Details and patient eligibility

About

The purpose of this study is to learn if pain can be relieved by delivering small amounts of electricity ("electrical stimulation") to the nerves relaying sensory information to the shoulder. This study will use a device called Sprint PNS system. PNS stands for Peripheral Nerve Stimulation. This device is cleared by the FDA for up to 60 days of use for relief of chronic or acute pain.

Enrollment: 20 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosed with degenerative changes within the shoulder complex

Key Exclusion Criteria:

• Pain exclusively in the anterior aspect of the shoulder
• Opioids for any condition other than shoulder pain
• Other implanted electronic device

Trial design

20 participants in 1 patient group

PNS Group

Description:

All subjects will receive the PNS device. The Sprint system delivers mild electrical stimulation to the shoulder. The Sprint system includes up to two leads (small wires) that are placed through your skin in your shoulder. The leads attach to devices worn on your body that delivers stimulation (stimulators).

Treatment:

Device: SPRINT PNS