Clinical trial NCT06152029: Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee
Official title: Efficacy of a Temporary Peripheral Nerve Stimulation System in Patients with Osteoarthritis of the Knee
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis, Knee
Osteoarthritis
Keywords: Peripheral nerve stimulation
PNS
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Average change from baseline to end of treatment in average pain intensity measured through BPI-SF item 5.
timeFrame: up to 60 days post lead placement
Secondary outcomes:
measure: Average change from baseline to end of treatment in health-related quality of life measured through PROMIS-29.
timeFrame: up to 60 days post lead placement
measure: Average change from baseline to end of treatment in pain interference measured through BPI-SF.
timeFrame: up to 60 days post lead placement
measure: Average change in chronic pain related medication intake at end of treatment compared to baseline in Morphine Miligram Equivalents (MME)
timeFrame: up to 60 days post lead placement
measure: Overall patient global impression of change (PGIC) at end of treatment.
timeFrame: up to 60 days post lead placement
measure: Overall incidence of lead migration/fracture at the end of treatment.
timeFrame: up to 60 days post lead placement
measure: 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.
timeFrame: 7 and 30 days post lead placement; and 6 and 12 month post lead pull
measure: Average change from baseline to 6- and 12-months post-explant in health-related quality of life measured through PROMIS-29.
timeFrame: 7 and 30 days post lead placement; and 6 and 12 month post lead pull
measure: Average change from baseline to 6- and 12-months post-explant in pain interference measured through BPI-SF.
timeFrame: 7 and 30 days post lead placement; and 6 and 12 month post lead pull
measure: Overall patient global impression of change (PGIC) at 6 months and end of study.
timeFrame: 6 and 12 months post lead pull
measure: Overall incidence of lead migration/fracture during the study.
timeFrame: 12 months
Other outcomes:
Locations:
city: Fond Du Lac
country: United States
facility: Aurora Health Center
state: Wisconsin
city: Oshkosh
country: United States
facility: Aurora Health Oshkosh
state: Wisconsin
Study officials:
affiliation: Director, Interventional Pain Medicine- Oshkosh & Fond du Lac Department of Anesthesiology
name: Mansoor M Aman, MD
role: PRINCIPAL_INVESTIGATOR
References: