Using temporary nerve stimulation to treat knee osteoarthritis pain

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

This study is testing whether a temporary nerve stimulation device can help adults with knee osteoarthritis pain feel better and improve their daily activities.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Wake Forest University Health Sciences (other)
• Locations: 2 sites (Fond Du Lac, Wisconsin and 1 other locations)
• Trial ID: NCT06152029 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the treatment outcomes of patients suffering from chronic knee pain due to osteoarthritis who receive a temporary peripheral nerve stimulation (PNS) system. Participants will be monitored for their pain levels and overall function following the intervention. The study focuses on understanding the effectiveness of PNS in managing knee pain and improving quality of life. Eligible participants must be 21 years or older and capable of providing informed consent.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older with chronic knee pain due to osteoarthritis who can comply with study requirements.

Not a fit: Patients with no knee pain at rest or those who have had recent nerve procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new, non-invasive option for managing chronic knee pain in osteoarthritis patients.

How similar studies have performed: While similar approaches using peripheral nerve stimulation have been explored, this specific application for knee osteoarthritis is still being evaluated.

Eligibility criteria

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

Where this trial is running

Fond Du Lac, Wisconsin and 1 other locations

• Aurora Health Center — Fond Du Lac, Wisconsin, United States (RECRUITING)
• Aurora Health Oshkosh — Oshkosh, Wisconsin, United States (RECRUITING)

Study contacts

• Principal investigator: Mansoor M Aman, MD — Director, Interventional Pain Medicine- Oshkosh & Fond du Lac Department of Anesthesiology
• Study coordinator: Mansoor M Aman, MD

Conditions: Osteoarthritis, Knee, Osteoarthritis, Peripheral nerve stimulation, PNS