Treatment of Shoulder Osteoarthritis

Recruiting

• Conditions: Chronic Shoulder Pain
• Interventions: Device: SPRINT PNS

• Registration Number: NCT05657587
• Lead Sponsor: Gramercy Pain Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PNS Group	SPRINT PNS	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).

Primary Outcome Measures

Name	Time	Method
Reduction in average pain and/or reduction in pain interference	15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment	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.)

Secondary Outcome Measures

Name	Time	Method
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	Shoulder range of motion is measured as degrees of active range of motion based on physical examination.
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 intensity will be assessed using the PROMIS-29 v2.0 profile. The measure assesses pain intensity using a single 0-10 numeric rating scale.
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	Changes in average pain interference are measured using Brief Pain Inventory--Short Form Question #9. The measure assesses pain interference using 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.)
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	Shoulder function is measured using the Western Ontario Arthritis of the Shoulder (WOOS) index. The WOOS index is a patient-reported, disease-specific questionnaire for the measurement of the quality-of-life in patients with osteoarthritis.

Trial Locations

Locations (1)

Gramercy Pain Center; 🇺🇸 Holmdel, New Jersey, United States