SPR PNS for Chronic Shoulder Pain

Launched by INTERNATIONAL SPINE, PAIN AND PERFORMANCE CENTER · Dec 5, 2022

Keywords

ClinConnect Summary

This clinical trial, called SPR PNS for Chronic Shoulder Pain, is looking into how well a device called the SPRINT Peripheral Nerve Stimulation (PNS) System works for treating long-lasting shoulder pain. This pain can come from issues like arthritis or injuries to the shoulder. The SPRINT PNS system uses mild electrical stimulation to help relieve pain and involves placing small wires under the skin of your shoulder, which connect to a wearable device that provides the stimulation. The goal of the study is to gather information about how effective this treatment is for patients experiencing chronic shoulder pain.

To participate in this trial, you need to be at least 21 years old and have been diagnosed with degenerative changes in your shoulder. You should also be scheduled for the SPRINT PNS procedure and have a pain score higher than 5 on a specific questionnaire. Participants in the study can expect to follow certain guidelines and share their experiences with the treatment. It's important to note that individuals with certain conditions, such as recent shoulder surgery or specific nerve issues, may not be eligible. Overall, this trial aims to provide valuable insights into a new option for managing chronic shoulder pain.

Gender

ALL

Eligibility criteria

• 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

Trial Officials