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| Name | Class |
|---|---|
| MetroHealth System, Ohio | OTHER |
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This is a retrospective-prospective study in which 40 patients have received a permanent Freedom PNS System. Subjects presented with chronic, intractable pain of peripheral nerve origin refractory to standard medical and/or surgical treatment.
A retrospective chart review will be conducted to assess baseline and follow-up parameters in patients who have received a permanent implant with the Freedom PNS system for at least 12 months. Missing data might be collected after informed consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Experimental | observational |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PNS device, observational study, no intervention during study | Device | PNS device, observational study, no intervention during study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | A text description of the subject's pain location(s) and severity will be recorded to correlate with subject feedback. The VRS will be used to measure severity. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Opioids | Each subject's opioid medication type, dose, frequency, and method of administration will be recorded at baseline and follow-up visit. | 12 months |
| Work status | Work history and status will be evaluated based on a subject's self-reported questionnaire(s) completed at screening/baseline and all follow up visits. |
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Inclusion Criteria:
A. Subject is ≥ 18 years of age at time permanent implant; B. Subject has been implanted with the Freedom PNS system; C. Subject is willing to attend visit as scheduled, and comply with the study requirements (if prospective); D. Patient is capable of giving informed consent.
Exclusion Criteria:
A. Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study (if prospective); B. Any additional active implanted devices for the treatment of chronic pain in addition to the Freedom PNS system.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Metrohealth System | Recruiting | Cleveland | Ohio | 44109 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Retrospective/Prospective
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| 12 months |
| GPES | Subject satisfaction with the implant will be measured by assessing global perceived effects (GPES) on a 7-point scale (1 = worst and 7 = best) | 12 months |
| Amount of sleep | Average hours of sleep per night will be evaluated at baseline and all follow-up visits | 12 months |
| Sleep disturbances | The amount of sleep disturbances (awakenings) per night to track quality of sleep | 12 months |
| EQ-5D-5L | The European Quality of Life - 5 Dimension - 5L (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome. | 12 months |
| Claims data | The value of claims data at the site will be measured from 1 year before and up to the date of implant and compared to the claims value up to 1 year after implant. The number of appointments will be collected together with the CPT codes used for pain interventions. | 12 months |