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Recruiting
NCT05649917
SPR PNS for Chronic Shoulder Pain
Conditions: Shoulder Pain, Shoulder Injuries, Shoulder Arthritis
Sex: All
Ages: 21 Years – 100 Years
Healthy volunteers: 1
Enrollment: 20
Sponsor: International Spine, Pain and Performance Center
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:At least 21 years oldDiagnosed with degenerative changes within the shoulder complexScheduled for a commercial SPRINT PNS procedureShoulder pain score at baseline >5 as demonstrated by PROMIS 29Able to understand and willing to take part in study and comply with all study requirementsExclusion Criteria:No shoulder pain at restPain exclusively in the anterior aspect of the shoulderConfounding conditions such as cervical radiculopathy, inflammatory arthritis, complete rotator cuff tear, or ipsilateral shoulder surgery in the past one yearDaily opioid use >90 m morphine equivalent at any point in the past monthOpioids for any condition other than shoulder painDeep 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 InvestigatorVulnerable populations (e.g., prisoners, minors, students, employees)Workers CompensationPregnant
Source: ClinicalTrials.gov (NCT05649917). StuddyBuddy aggregates publicly available trial information.