Shoulder Pain Clinical Trial
Official title:
A Post-Market Observational Case Series Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Chronic Shoulder Pain
NCT number | NCT05649917 |
Other study ID # | 20223406 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 6, 2022 |
Est. completion date | July 2024 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | July 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | International Spine Pain & Performance Center | Arlington | Virginia |
United States | International Spine Pain & Performance Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
International Spine, Pain and Performance Center | SPR Therapeutics, Inc. |
United States,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in average pain and/or reduction in pain interference | Average pain intensity is measured using the PROMIS-29 v2.0 profile. The measure assesses pain intensity using a single 0-10 numeric rating scale. Average pain interference is measured using Brief Pain Inventory--Short Form Question #9 (BPI-9). BPI-9 uses a 0-10 numeric rating scale across seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance.) | 3 months | |
Secondary | Changes in pain intensity | Changes in pain intensity will be assessed using the PROMIS-29 v2.0 profile. The measure assesses pain intensity using a single 0-10 numeric rating scale. | 1 year | |
Secondary | Changes in pain interference | Changes in average pain interference are measured using Brief Pain Inventory--Short Form Question #9. The measure assesses pain interference using a 0-10 numeric rating scale across seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance.) | 1 year | |
Secondary | Changes in Shoulder Function | Shoulder function is measured using the Western Ontario Arthritis of the Shoulder (WOOS) index. The WOOS index is a patient-reported, disease-specific questionnaire for the measurement of the quality-of-life in patients with osteoarthritis. | 1 year | |
Secondary | Changes in shoulder range of motion | Shoulder range of motion is measured as degrees of active range of motion (flexion, abduction, internal rotation, and external rotation) based on physical examination. | 1 year |
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