Treatment of Shoulder Osteoarthritis

NCT05657587 | Unknown FDA Device

• 1 other identifier: 0001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Reduction in average pain and/or reduction in pain interference

  Average pain intensity is measured using the PROMIS-29 v2.0 profile. The measure assesses pain intensity using a single 0-10 numeric rating scale. Average pain interference is measured using Brief Pain Inventory--Short Form Question #9 (BPI-9). BPI-9 uses a 0-10 numeric rating scale across seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance.)

  15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment

Secondary Outcomes (4)

• Changes in pain intensity

  baseline, start of treatment (lead placement); 15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment

• Changes in pain interference

  baseline, start of treatment (lead placement); 15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment

• Range of motion of the shoulder

  baseline, start of treatment (lead placement); 2 months, 3 months, 6 months, and 12 months post Start of Treatment

• Changes in Shoulder Function

  baseline, start of treatment (lead placement); 15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment

Study Arms (1)

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).

Device: SPRINT PNS

Interventions

SPRINT PNS 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).

PNS Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with pain due to degenerative changes in the shoulder scheduled for commercial placement of the Sprint PNS system

You may qualify if:

• Diagnosed with degenerative changes within the shoulder complex

You may not qualify if:

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

Sponsors & Collaborators

• Gramercy Pain Center: lead

Study Sites (1)

Gramercy Pain Center

Holmdel, New Jersey, 07733, United States

RECRUITING

Central Study Contacts

Angela Sollitto

CONTACT

7323201457; angelas@gramercypaincenter.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: December 20, 2022
• Study Start: April 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

US (1)