Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06152029
• Other study ID #: 23-832
• Secondary ID: 23.135E
• Status: Recruiting
• Start date: November 15, 2023
• Est. completion date: June 15, 2025

Study information

• Verified date: November 2023
• Source: Aurora Health Care
• Contact: Mansoor M Aman, MD
• Phone: 9204567715
• Email: mansoor.aman[@]aah.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 15, 2025
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Temporary PNS system
This system remains in place up to 60 days, then removed.

Locations

Country	Name	City	State
United States	Aurora Health Center	Fond Du Lac	Wisconsin
United States	Aurora Health Oshkosh	Oshkosh	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Mansoor Aman, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Average change from baseline to end of treatment in pain interference measured through BPI-SF.		up to 60 days post lead placement
Secondary	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
Secondary	Overall patient global impression of change (PGIC) at end of treatment.		up to 60 days post lead placement
Secondary	Overall incidence of lead migration/fracture at the end of treatment.		up to 60 days post lead placement
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall patient global impression of change (PGIC) at 6 months and end of study.		6 and 12 months post lead pull
Secondary	Overall incidence of lead migration/fracture during the study.		12 months