SPR PNS for Chronic Shoulder Pain
Status unconfirmed
Conditions studied: Shoulder Pain, Shoulder Injuries, Shoulder Arthritis
In brief
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.
Key facts
- Study ID
- NCT05649917
- Run by
- International Spine, Pain and Performance Center
- People needed
- 20
- Starts
- 2022-07-06
- Expected to finish
- 2024-07-01
- Last updated by the study team
- 2023-09-28
Who can join
Age: 21 and older, up to 100. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- International Spine Pain & Performance Center — Washington D.C., District of Columbia, United States (enrolling)
- International Spine Pain & Performance Center — Arlington, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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