Retrospective-Prospective PNS Study

Curonix LLC40 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Chronic Pain

Interventions

PNS device, observational study, no intervention during studyDEVICE

PNS device, observational study, no intervention during study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Metrohealth System

Cleveland, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

Opioids

Each subject's opioid medication type, dose, frequency, and method of administration will be recorded at baseline and follow-up visit.

Time frame: 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.

Time frame: 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)

Time frame: 12 months

Amount of sleep

Average hours of sleep per night will be evaluated at baseline and all follow-up visits

Time frame: 12 months

Sleep disturbances

The amount of sleep disturbances (awakenings) per night to track quality of sleep

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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