Retrospective-Prospective PNS Study

Not Applicable

Recruiting

• Conditions: Chronic Pain

• Registration Number: NCT06845631
• Lead Sponsor: Curonix LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Opioids	12 months	Each subject's opioid medication type, dose, frequency, and method of administration will be recorded at baseline and follow-up visit.
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
Sleep disturbances	12 months	The amount of sleep disturbances (awakenings) per night to track quality of sleep
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.

Trial Locations

Locations (1)

The Metrohealth System; 🇺🇸 Cleveland, Ohio, United States