SPR PNS for Chronic Shoulder Pain

September 26, 2023 updated by: Mehul J. Desai, International Spine, Pain and Performance Center

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

The purpose of this research is to gather post-market data regarding the effectiveness of the SPRINT Peripheral Nerve Stimulation (PNS) System for the treatment of chronic shoulder pain due to chronic degenerative changes of your shoulder. The System delivers mild electrical stimulation to the muscles in your shoulder. The System includes up to two leads (small wires) that are placed through your skin into your shoulder. The leads attach to a device worn on your body that deliver stimulation (called a Stimulator). The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Background

Chronic degenerative changes in the shoulder are a frequent source of debilitating chronic pain. In particular, osteoarthritis of the shoulder has been estimated to affect up to 32.8% of the adult population over the age of 60, and OA in general is one of the most frequent causes of disability in the United States.1 OA impacts the quality of life of tens of millions of Americans and carries a significant economic burden of over $60 billion in the U.S. each year.2

Degenerative joint disease in the shoulder is commonly managed with physical therapy and over-the-counter medications, but these modalities can be insufficient for pain management as degeneration progresses.3 Corticosteroid injections, radiofrequency ablations, and even partial or total shoulder arthroplasty are used to treat advanced cases3, and these interventions often either have limited long-term effectiveness or are associated with significant invasiveness or other side effects and complications.

Peripheral nerve stimulation (PNS) is a neuromodulatory technique that seeks to provide pain relief through stimulation of the nerves that innervate the shoulder (e.g., the suprascapular nerve and axillary nerve). A novel, 60-day percutaneous PNS system that is FDA-cleared has shown effectiveness for chronic shoulder pain following stroke and shoulder impingement syndrome4-15, and has demonstrated the potential to provide sustained relief following the short-term, 60-day treatment.8, 15-18 The mechanism of action of neuropathic pain in osteoarthritis is proposed to be via peripheral sensitization (e.g., axillary and suprascapular nerves) that leads to subsequent upstream hypersensitization of the central nervous system; the proposed mechanism of long-term pain relief with 60-day PNS via reconditioning of the CNS to reverse hypersensitization therefore suggests that the treatment may be effective for degenerative shoulder including OA.19, 20 However, no study has prospectively evaluated the use of 60-day, percutaneous PNS for the treatment of debilitating pain associated with degenerative changes in the shoulder. The goal of this study is therefore to collect data on the use of 60-day PNS for the treatment of chronic pain associated with degenerative shoulder.

Objectives

The study objective is to gather post-market data regarding the effectiveness of the SPRINT PNS System for the treatment of chronic shoulder pain due to degenerative changes of the shoulder.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20006
        • Recruiting
        • International Spine Pain & Performance Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mehul Desai, MD, MPH
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Recruiting
        • International Spine Pain & Performance Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mehul Desai, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will enroll up to 20 patients with pain due to degenerative changes in the shoulder scheduled for commercial placement of the SPRINT PNS System.

Description

Inclusion Criteria:

  • At least 21 years old
  • Diagnosed with degenerative changes within the shoulder complex
  • Scheduled for a commercial SPRINT PNS procedure
  • Shoulder pain score at baseline >5 as demonstrated by PROMIS 29
  • Able to understand and willing to take part in study and comply with all study requirements

Exclusion Criteria:

  • No shoulder pain at rest
  • Pain exclusively in the anterior aspect of the shoulder
  • Confounding conditions such as cervical radiculopathy, inflammatory arthritis, complete rotator cuff tear, or ipsilateral shoulder surgery in the past one year
  • Daily opioid use >90 m morphine equivalent at any point in the past month
  • Opioids for any condition other than shoulder pain
  • Deep brain stimulation (DBS) system, implanted active cardiac implant (e.g. pacemaker or defibrillator), or any other implantable neuro-stimulator whose stimulus current pathway may overlap with the SPRINT system.
  • Any other condition that may interfere with the ability to participate in a clinical trial (e.g. anatomy that may interfere with lead placement, nerve damage, compromised immune system, uncontrolled DM) as determined by the Investigator
  • Vulnerable populations (e.g., prisoners, minors, students, employees)
  • Workers Compensation
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in average pain and/or reduction in pain interference
Time Frame: 3 months
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.)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in pain intensity
Time Frame: 1 year
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.
1 year
Changes in pain interference
Time Frame: 1 year
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.)
1 year
Changes in Shoulder Function
Time Frame: 1 year
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.
1 year
Changes in shoulder range of motion
Time Frame: 1 year
Shoulder range of motion is measured as degrees of active range of motion (flexion, abduction, internal rotation, and external rotation) based on physical examination.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Spine, Pain and Performance Center

Collaborators

SPR Therapeutics, Inc.

Investigators

  • Principal Investigator: Mehul Desai, MD, MPH, International Spine Pain & Performance Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

December 5, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20223406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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