Treatment of Shoulder Osteoarthritis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Shoulder Pain
• Intervention / Treatment: Device: SPRINT PNS

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Angela Sollitto; Phone Number: 7323201457; Email: angelas@gramercypaincenter.com

Study Locations

• United States
  • New Jersey
    • Holmdel, New Jersey, United States, 07733
      • Recruiting
      • Gramercy Pain Center
      • Principal Investigator: Ali Valimahomed, MD
      • Contact: Angela Sollitto, BS; Phone Number: 732-320-1457; Email: angelas@gramercypaincenter.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Gramercy Pain Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 0001 (Researcher)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No