Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee

• Sponsor: Mansoor Aman, MD (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06152029
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Anticipated Duration (Months): 19
• Patients Per Site: 20
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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	Intervention/Treatment	Phase
Osteoarthritis, Knee; Osteoarthritis	Device: Temporary PNS system

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Efficacy of a Temporary Peripheral Nerve Stimulation System in Patients With Osteoarthritis of the Knee
• Actual Study Start Date: Nov 15, 2023
• Anticipated Primary Completion Date: Jun 15, 2024
• Anticipated Study Completion Date: Jun 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
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; This system remains in place up to 60 days, then removed.; Other Names: SPRINT PNS System

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. 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]

2. Average change from baseline to end of treatment in pain interference measured through BPI-SF. [up to 60 days post lead placement]

3. 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]

4. Overall patient global impression of change (PGIC) at end of treatment. [up to 60 days post lead placement]

5. Overall incidence of lead migration/fracture at the end of treatment. [up to 60 days post lead placement]

6. 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]

7. 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]

8. 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]

9. Overall patient global impression of change (PGIC) at 6 months and end of study. [6 and 12 months post lead pull]

10. Overall incidence of lead migration/fracture during the study. [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aurora Health Center	Fond Du Lac	Wisconsin	United States	54937
2	Aurora Health Oshkosh	Oshkosh	Wisconsin	United States	54914

Sponsors and Collaborators

• Mansoor Aman, MD

Investigators

• Principal Investigator: Mansoor M Aman, MD, Director, Interventional Pain Medicine- Oshkosh & Fond du Lac Department of Anesthesiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mansoor Aman, MD, Director, Interventional Pain Medicine- Oshkosh & Fond du Lac Department of Anesthesiology, Aurora Health Care
• ClinicalTrials.gov Identifier: NCT06152029
• Other Study ID Numbers: 23-832; 23.135E
• First Posted: Nov 30, 2023
• Last Update Posted: Nov 30, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mansoor Aman, MD, Director, Interventional Pain Medicine- Oshkosh & Fond du Lac Department of Anesthesiology, Aurora Health Care: Peripheral nerve stimulation; PNS
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Nov 30, 2023