RECRUITING

Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee

Conditions

Osteoarthritis, Knee Osteoarthritis Peripheral nerve stimulation PNS

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to demonstrate the treatment outcomes of patients with chronic knee pain secondary to osteoarthritis that have received a temporary peripheral nerve stimulation system.

Official Title

Efficacy of a Temporary Peripheral Nerve Stimulation System in Patients with Osteoarthritis of the Knee

Quick Facts

Study Start:2023-11-15

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06152029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age of 21 and older * Will receive a temporary PNS system for the management of chronic knee pain secondary to osteoarthritis * Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English * Be willing and capable of giving informed consent * Be willing and able to comply with study-related requirements, procedures, and scheduled visits	* No knee pain at rest * Same nerve targeted for both Radiofrequency Ablation (RFA) and Peripheral Nerve Stimulation (PNS) in less than 6 months post RFA, if applicable * Pregnancy * History of repetitive skin infections * Vulnerable populations (e.g., prisoners, minors, students, employees) * Any other condition that may interfere with the ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement, nerve damage, compromised immune system, uncontrolled diabetes) * Confounding conditions such as lumbar radiculopathy * Deep brain stimulation system, implanted active cardiac implant (e.g. pacemaker of defibrillator), or any other implantable neuro-stimulator whose stimulus current pathway may overlap the SPRINT system. * Be involved in an injury claim under current litigation * Be a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to chronic pain * Have a pending or approved worker's compensation claim

Inclusion Criteria

Exclusion Criteria

* Age of 21 and older
* Will receive a temporary PNS system for the management of chronic knee pain secondary to osteoarthritis
* Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English
* Be willing and capable of giving informed consent
* Be willing and able to comply with study-related requirements, procedures, and scheduled visits

* No knee pain at rest
* Same nerve targeted for both Radiofrequency Ablation (RFA) and Peripheral Nerve Stimulation (PNS) in less than 6 months post RFA, if applicable
* Pregnancy
* History of repetitive skin infections
* Vulnerable populations (e.g., prisoners, minors, students, employees)
* Any other condition that may interfere with the ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement, nerve damage, compromised immune system, uncontrolled diabetes)
* Confounding conditions such as lumbar radiculopathy
* Deep brain stimulation system, implanted active cardiac implant (e.g. pacemaker of defibrillator), or any other implantable neuro-stimulator whose stimulus current pathway may overlap the SPRINT system.
* Be involved in an injury claim under current litigation
* Be a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to chronic pain
* Have a pending or approved worker's compensation claim

Contacts and Locations

Study Contact

Mansoor M Aman, MD

CONTACT

9204567715

mansoor.aman@aah.org

Merve Buluk Figueira, MS

CONTACT

9204561551

merve.figueira@aah.org

Principal Investigator

Mansoor M Aman, MD

PRINCIPAL_INVESTIGATOR

Director, Interventional Pain Medicine- Oshkosh & Fond du Lac Department of Anesthesiology

Study Locations (Sites)

Aurora Health Center

Fond Du Lac, Wisconsin, 54937

United States

Aurora Health Oshkosh

Oshkosh, Wisconsin, 54914

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Mansoor M Aman, MD, PRINCIPAL_INVESTIGATOR, Director, Interventional Pain Medicine- Oshkosh & Fond du Lac Department of Anesthesiology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-15

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-11-15

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Peripheral nerve stimulation
PNS

Additional Relevant MeSH Terms

Osteoarthritis, Knee
Osteoarthritis