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

Wake Forest University Health Sciences2 sites in 1 country12 target enrollmentNovember 15, 2023

ConditionsOsteoarthritis, Knee Osteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis, Knee
Sponsor: Wake Forest University Health Sciences
Enrollment: 12
Locations: 2
Primary Endpoint: Average change from baseline to end of treatment in average pain intensity measured through BPI-SF item 5.
Status: Terminated
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 15, 2023

End Date

October 20, 2025

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Wake Forest University Health Sciences

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Average change from baseline to end of treatment in average pain intensity measured through BPI-SF item 5.

Time Frame: up to 60 days post lead placement

Secondary Outcomes

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