Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2022-04-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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PNS Group
All subjects will receive the PNS device. The Sprint system delivers mild electrical stimulation to the shoulder. The Sprint system includes up to two leads (small wires) that are placed through your skin in your shoulder. The leads attach to devices worn on your body that delivers stimulation (stimulators).
SPRINT PNS
Each subject will have 2 leads placed for 60 days. The Sprint system delivers mild electrical stimulation to the shoulder. The Sprint system includes up to two leads (small wires) that are placed through your skin in your shoulder. The leads attach to devices worn on your body that delivers stimulation (stimulators).
Interventions
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SPRINT PNS
Each subject will have 2 leads placed for 60 days. The Sprint system delivers mild electrical stimulation to the shoulder. The Sprint system includes up to two leads (small wires) that are placed through your skin in your shoulder. The leads attach to devices worn on your body that delivers stimulation (stimulators).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Opioids for any condition other than shoulder pain
* Other implanted electronic device
21 Years
ALL
No
Sponsors
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Gramercy Pain Center
OTHER
Responsible Party
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Locations
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Gramercy Pain Center
Holmdel, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0001
Identifier Type: -
Identifier Source: org_study_id
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