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NCT Number: NCT06845631

Retrospective-Prospective PNS Study

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Metrohealth System

Cleveland, Ohio, 44109, United States

Location status: Recruiting

Location contact

Brendan Astley, MD

PRINCIPAL_INVESTIGATOR

Samantha Pope

CONTACT

[email protected]

216-778-1270

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PNS device, observational study, no intervention during study

Device

PNS device, observational study, no intervention during study

Primary outcomes

  1. Pain scores

    Time frame: 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 outcomes

  1. Opioids

    Time frame: 12 months

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

  2. Work status

    Time frame: 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.

  3. GPES

    Time frame: 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)

  4. Amount of sleep

    Time frame: 12 months

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

  5. Sleep disturbances

    Time frame: 12 months

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

  6. EQ-5D-5L

    Time frame: 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.

  7. Claims data

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Curonix LLC

Industry

Collaborators

  • MetroHealth System, Ohio

Registry information

Official study title

Retrospective-Prospective Clinical Trial Investigating the Treatment of Chronic Pain With the Freedom Peripheral Nerve Stimulation System

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 25, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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