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NCT06152029 | RECRUITING | Osteoarthritis, Knee

Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee
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.

Condition or disease

Osteoarthritis, Knee

Osteoarthritis

Intervention/treatment

Temporary PNS system

Study Type : OBSERVATIONAL
Estimated Enrollment : 40 participants
Official Title : Efficacy of a Temporary Peripheral Nerve Stimulation System in Patients With Osteoarthritis of the Knee
Actual Study Start Date : 2023-11-15
Estimated Primary Completion Date : 2024-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee

Location Details

NCT06152029

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Wisconsin

Aurora Health Center

Fond Du Lac, Wisconsin, United States, 54937

RECRUITING

United States, Wisconsin

Aurora Health Oshkosh

Oshkosh, Wisconsin, United States, 54914