Retrospective-Prospective PNS Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PNS device, observational study, no intervention during study.
- Who it may be relevant to
- Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Retrospective-Prospective Clinical Trial Investigating the Treatment of Chronic Pain With the Freedom Peripheral Nerve Stimulation System
Overview
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
- Device PNS device, observational study, no intervention during study
PNS device, observational study, no intervention during study
Primary outcome measures
- Pain scores [Time frame: 12 months]
Secondary outcome measures (7)
- Opioids [Time frame: 12 months]
- Work status [Time frame: 12 months]
- GPES [Time frame: 12 months]
- Amount of sleep [Time frame: 12 months]
- Sleep disturbances [Time frame: 12 months]
- EQ-5D-5L [Time frame: 12 months]
- Claims data [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- The Metrohealth System — Cleveland
Identifiers
NCT: NCT06845631 · P011