Chronic Pain
Conditions
Keywords
chronic pain, PNS, Retrospective, prospective
Brief summary
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.
Interventions
DEVICEPNS device, observational study, no intervention during study
PNS device, observational study, no intervention during study
Sponsors
MetroHealth System, Ohio
Curonix LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Retrospective/Prospective
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Work status | 12 months | 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. |
| GPES | 12 months | Subject satisfaction with the implant will be measured by assessing global perceived effects (GPES) on a 7-point scale (1 = worst and 7 = best) |
| Amount of sleep | 12 months | Average hours of sleep per night will be evaluated at baseline and all follow-up visits |
| Opioids | 12 months | Each subject's opioid medication type, dose, frequency, and method of administration will be recorded at baseline and follow-up visit. |
| EQ-5D-5L | 12 months | The European Quality of Life - 5 Dimension - 5L (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome. |
| Claims data | 12 months | 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. |
| Sleep disturbances | 12 months | The amount of sleep disturbances (awakenings) per night to track quality of sleep |
Countries
United States
Outcome results
None listed