Recruiting

Shoulder Osteoarthritis

Sponsor:

Gramercy Pain Center

Code:

NCT05657587

Conditions

Chronic Shoulder Pain

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

SPRINT PNS

Study Details

Brief 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

Study ID

NCT05657587

Start date

Apr 1, 2022

Status verified date

Feb, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Interventions

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).

Primary outcome measure

  • Reduction in average pain and/or reduction in pain interference [ Time Frame: 15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment ]

Central Contacts and Locations

Central contacts

Angela Sollitto

7323201457angelas@gramercypaincenter.com

Locations

Gramercy Pain Center

Recruiting

Holmdel, New Jersey, United States, 07733

Contacts

Angela Sollitto, BS

732-320-1457angelas@gramercypaincenter.com

Principal Investigator:

Ali Valimahomed, MD

More Information

Sponsor

Gramercy Pain Center

Last update posted

Feb 27, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gramercy Pain Center on 2023-02-27.