NCT06152029

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
Last Updated

November 6, 2025

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

November 15, 2023

Last Update Submit

November 4, 2025

Conditions

Osteoarthritis, KneeOsteoarthritis

Keywords

Peripheral nerve stimulationPNS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (1)

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

Interventions

Temporary PNS systemDEVICE

This system remains in place up to 60 days, then removed.

Also known as: SPRINT PNS System
Patients treated with a temporary PNS system

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aurora Health Center

Fond du Lac, Wisconsin, 54937, United States

Location

Aurora Health Oshkosh

Oshkosh, Wisconsin, 54914, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Littlefield Lauren, MD

    Aurora Medical Center Oshkosh - 855 N Westhaven Dr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 30, 2023

Study Start

November 15, 2023

Primary Completion

October 20, 2025

Study Completion

October 20, 2025

Last Updated

November 6, 2025

Record last verified: 2025-11

Locations

US(2)