SPR PNS for Chronic Shoulder Pain
Unknown statusNCT05649917
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- A Post-Market Observational Case Series Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Chronic Shoulder Pain
- Conditions
- Shoulder Pain
- Shoulder Injuries
- Shoulder Arthritis
- Sponsor
- International Spine, Pain and Performance Center
- Collaborators
- SPR Therapeutics, Inc.
- Start date
- 2022-07-06
- Primary completion
- 2024-06
- Sex
- All
- Age range
- from 21 Years to 100 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05649917