Treatment of Shoulder Osteoarthritis

NCT ID: NCT05657587

Last Updated: 2023-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Shoulder Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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PNS Group

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).

SPRINT PNS

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with degenerative changes within the shoulder complex

Exclusion Criteria

* Pain exclusively in the anterior aspect of the shoulder
* Opioids for any condition other than shoulder pain
* Other implanted electronic device
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gramercy Pain Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gramercy Pain Center

Holmdel, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Angela Sollitto

Role: CONTACT

7323201457

Facility Contacts

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Angela Sollitto, BS

Role: primary

732-320-1457

Other Identifiers

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0001

Identifier Type: -

Identifier Source: org_study_id

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