Retrospective PNS Study

Active, not recruiting

• Conditions: Chronic Pain

• Registration Number: NCT06832449
• Lead Sponsor: Curonix LLC

Brief Summary

Retrospective PNS Study

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-12
• Last Update Submitted: 2025-02-12
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

A. Subjects are at least 18 years of age, B. Subjects have been diagnosed with refractory chronic pain, C. Subject has been implanted with a permanent Freedom Peripheral Nerve Stimulation System.

Exclusion Criteria

A. Any additional active implanted devices for the treatment of chronic pain in addition to the Freedom Peripheral Nerve Stimulation System.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VRS	36 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
Health economic 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)

Colorado Pain Care; 🇺🇸 Denver, Colorado, United States