Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis; Osteoarthritis, Knee
• Intervention / Treatment: Device: Temporary PNS system

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Merve Buluk Figueira, MS; Phone Number: 9204561551; Email: merve.figueira@aah.org
• Study Contact Backup: Name: Mansoor M Aman, MD; Phone Number: 9204567715; Email: mansoor.aman@aah.org

Study Locations

• United States
  • Wisconsin
    • Fond Du Lac, Wisconsin, United States, 54937
      • Recruiting
      • Aurora Health Center
      • Contact: Merve Buluk Figueira, MS; Phone Number: 920-456-1551; Email: merve.figueira@aah.org
      • Sub-Investigator: Lauren Littlefield, MD
    • Oshkosh, Wisconsin, United States, 54914
      • Recruiting
      • Aurora Health Oshkosh
      • Principal Investigator: Mansoor Aman, MD
      • Sub-Investigator: Vishal Patel, MD
      • Contact: Merve Buluk Figueira, MS; Phone Number: 920-456-1551; Email: merve.figueira@aah.org
      • Sub-Investigator: Lauren Littlefield, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Study population includes patients with chronic knee pain secondary to osteoarthritis of the knee and will receive a temporary peripheral nerve stimulation device.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated with a temporary PNS system; These patients will receive a temporary PNS system for their knee pain secondary to osteoarthritis	Device: Temporary PNS system; This system remains in place up to 60 days, then removed.; Other Names: SPRINT PNS System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average change from baseline to end of treatment in average pain intensity measured through BPI-SF item 5.	up to 60 days post lead placement

Secondary Outcome Measures

Outcome Measure	Time Frame
Average change from baseline to end of treatment in health-related quality of life measured through PROMIS-29.	up to 60 days post lead placement
Average change from baseline to end of treatment in pain interference measured through BPI-SF.	up to 60 days post lead placement
Average change in chronic pain related medication intake at end of treatment compared to baseline in Morphine Miligram Equivalents (MME)	up to 60 days post lead placement
Overall patient global impression of change (PGIC) at end of treatment.	up to 60 days post lead placement
Overall incidence of lead migration/fracture at the end of treatment.	up to 60 days post lead placement
Average change from baseline to 7- and 30-days post-implant; and 6- and 12-months post-explant in average pain intensity measured through BPI-SF item 5.	7 and 30 days post lead placement; and 6 and 12 month post lead pull
Average change from baseline to 6- and 12-months post-explant in health-related quality of life measured through PROMIS-29.	7 and 30 days post lead placement; and 6 and 12 month post lead pull
Average change from baseline to 6- and 12-months post-explant in pain interference measured through BPI-SF.	7 and 30 days post lead placement; and 6 and 12 month post lead pull
Overall patient global impression of change (PGIC) at 6 months and end of study.	6 and 12 months post lead pull
Overall incidence of lead migration/fracture during the study.	12 months

Collaborators and Investigators

• Sponsor: Mansoor Aman, MD
• Investigators: Principal Investigator: Mansoor M Aman, MD, Director, Interventional Pain Medicine- Oshkosh & Fond du Lac Department of Anesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: PNS; Peripheral nerve stimulation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 23-832; 23.135E (Other Identifier: Aurora IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No