Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee

Stopped early

Conditions studied: Osteoarthritis, Knee, Osteoarthritis

In brief

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.

Key facts

Study ID

NCT06152029

Run by

Wake Forest University Health Sciences

People needed

12

Starts

2023-11-15

Expected to finish

2025-10-20

Last updated by the study team

2025-11-06

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Aurora Health Center — Fond du Lac, Wisconsin, United States
• Aurora Health Oshkosh — Oshkosh, Wisconsin, United States

Full record on ClinicalTrials.gov

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