NCT05657587

Treatment of Shoulder Osteoarthritis

A Post Market Observational Case Series Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Chronic Shoulder Pain

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Gramercy Pain Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Shoulder Pain

Interventions

Type	Name	Description
DEVICE	SPRINT PNS	Each subject will have 2 leads placed for 60 days. 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).

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-12-20
• Last updated: 2023-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study