Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee

Wake Forest University (WFU)

Status: Enrolling

Conditions: Osteoarthritis; Osteoarthritis, Knee

Treatments: Device: Temporary PNS system

Study type: Observational

Funder types: Other

Identifiers

NCT06152029

23.135E (Other Identifier)

IRB00104845

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion 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

Exclusion criteria

• 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

Trial design

40 participants in 1 patient group

Patients treated with a temporary PNS system

Description:

These patients will receive a temporary PNS system for their knee pain secondary to osteoarthritis

Treatment:

Device: Temporary PNS system