Treatment of Shoulder Osteoarthritis

Chronic Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05657587
• Other study ID #: 0001
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Gramercy Pain Center
• Contact: Angela Sollitto
• Phone: 7323201457
• Email: angelas[@]gramercypaincenter.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Shoulder Pain
• Shoulder Pain

Intervention

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).

Locations

Country	Name	City	State
United States	Gramercy Pain Center	Holmdel	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Gramercy Pain Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in pain intensity	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.	baseline, start of treatment (lead placement); 15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment
Secondary	Changes in pain interference	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.)	baseline, start of treatment (lead placement); 15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment
Secondary	Range of motion of the shoulder	Shoulder range of motion is measured as degrees of active range of motion based on physical examination.	baseline, start of treatment (lead placement); 2 months, 3 months, 6 months, and 12 months post Start of Treatment
Secondary	Changes in Shoulder Function	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.	baseline, start of treatment (lead placement); 15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment