Using Peripheral Nerve Stimulation for Chronic Shoulder Pain
A Post-Market Observational Case Series Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Chronic Shoulder Pain
This study is testing if a new device that sends mild electrical signals to the shoulder can help people with chronic shoulder pain feel better over a longer period of time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 21 Years to 100 Years |
| Sex | All |
| Sponsor | International Spine, Pain and Performance Center Academic / other |
| Locations | 2 sites (Washington, District of Columbia and 1 other locations) |
| Trial ID | NCT05649917 on ClinicalTrials.gov |
What this trial studies
This research gathers post-market data on the effectiveness of the SPRINT Peripheral Nerve Stimulation (PNS) System for treating chronic shoulder pain caused by degenerative changes. The system delivers mild electrical stimulation to shoulder muscles through small wires placed under the skin, connected to a wearable device. The FDA has cleared this device for up to 60 days of use to relieve chronic or acute pain. The study aims to evaluate the long-term effectiveness of this neuromodulatory technique in managing shoulder pain.
Who should consider this trial
Good fit: Ideal candidates include adults over 21 with diagnosed degenerative changes in the shoulder and a baseline pain score greater than 5.
Not a fit: Patients with no shoulder pain at rest or those with specific confounding conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide significant pain relief for patients suffering from chronic shoulder pain.
How similar studies have performed: Previous studies have shown that similar peripheral nerve stimulation techniques can be effective for chronic shoulder pain, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Washington, District of Columbia and 1 other locations
- International Spine Pain & Performance Center — Washington, District of Columbia, United States (Recruiting)
- International Spine Pain & Performance Center — Arlington, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Mehul Desai, MD, MPH — International Spine Pain & Performance Center
- Study coordinator: Mehul J Desai, MD, MPH
- Email: research@isppcenter.com
- Phone: 202-808-8295
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.