Chronic Shoulder Pain
Conditions
Brief summary
The purpose of this study is to learn if pain can be relieved by delivering small amounts of electricity (electrical stimulation) to the nerves relaying sensory information to the shoulder. This study will use a device called Sprint PNS system. PNS stands for Peripheral Nerve Stimulation. This device is cleared by the FDA for up to 60 days of use for relief of chronic or acute pain.
Interventions
DEVICESPRINT 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).
Sponsors
Gramercy Pain Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosed with degenerative changes within the shoulder complex Key
Exclusion criteria
* Pain exclusively in the anterior aspect of the shoulder * Opioids for any condition other than shoulder pain * Other implanted electronic device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in average pain and/or reduction in pain interference | 15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment | 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.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in pain intensity | baseline, start of treatment (lead placement); 15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment | 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. |
| Changes in pain interference | baseline, start of treatment (lead placement); 15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment | 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.) |
| Range of motion of the shoulder | baseline, start of treatment (lead placement); 2 months, 3 months, 6 months, and 12 months post Start of Treatment | Shoulder range of motion is measured as degrees of active range of motion based on physical examination. |
| Changes in Shoulder Function | baseline, start of treatment (lead placement); 15 days, 1 month, 2 months, 3 months, 6 months, and 12 months post Start of Treatment | 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. |
Countries
United States
Contacts
Primary ContactAngela Sollitto
Outcome results
None listed