Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee

Recruiting

• Conditions: Osteoarthritis; Osteoarthritis, Knee
• Interventions: Device: Temporary PNS system

• Registration Number: NCT06152029
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with a temporary PNS system	Temporary PNS system	These patients will receive a temporary PNS system for their knee pain secondary to osteoarthritis

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Overall incidence of lead migration/fracture during the study.	12 months
Overall patient global impression of change (PGIC) at end of treatment.	up to 60 days post lead placement
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
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
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
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
Overall patient global impression of change (PGIC) at 6 months and end of study.	6 and 12 months post lead pull

Trial Locations

Locations (2)

Aurora Health Center; 🇺🇸 Fond Du Lac, Wisconsin, United States

Aurora Health Oshkosh; 🇺🇸 Oshkosh, Wisconsin, United States