SPR PNS for Chronic Shoulder Pain

Description

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.

Conditions

Shoulder Pain, Shoulder Injuries, Shoulder Arthritis

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Study Overview

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Study Details

Study overview

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.

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

SPR PNS for Chronic Shoulder Pain

Condition
Shoulder Pain
Intervention / Treatment

-

Contacts and Locations

Washington

International Spine Pain & Performance Center, Washington, District of Columbia, United States, 20006

Arlington

International Spine Pain & Performance Center, Arlington, Virginia, United States, 22205

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

21 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

International Spine, Pain and Performance Center,

Mehul Desai, MD, MPH, PRINCIPAL_INVESTIGATOR, International Spine Pain & Performance Center

Study Record Dates

2024-07