VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain

Can Virtual Reality Improve Patient Tolerance in Patients Undergoing Water Cooled Genicular Nerve Radio Frequency Ablation in Patients With Chronic Knee Pain? A Randomized Controlled Trial

This study will examine the impact of virtual reality used in conjunction with sedation compared to sedation alone in patients undergoing watervcooled genicular nerve ablations for chronic knee pain.

The goals of the study is to determine the relative efficacy of virtual reality as a distraction modality when used as an adjuvant to procedural sedation compared to sedation alone for procedure related pain. To assess procedural satisfaction, and 1-month pain and functional outcomes.To explore whether virtual reality and lower procedure-related pain scores affect 1-month outcomes. And finally to determine whether demographic and clinical characteristics are associated with outcome measures.

Study Overview

• Status: Recruiting
• Conditions: Pain, Chronic
• Intervention / Treatment: Other: Experimental: Group #1: Virtual Reality Headset; Other: Group 2 No Virtual Reality Headset

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul Fitzgerald, RN,BSN,MS; Phone Number: 312-695-1064; Email: p-fitzgerald2@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Medicine Pain Center
      • Contact: Paul Fitzgerald; Phone Number: 312-695-1064; Email: p-fitzgerald2@northwestern.edu
      • Principal Investigator: Jason Ross, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing genicular RFA will be eligible for inclusion in the study
• Patients with knee pain, baseline average of > 4/10
• X-ray evidence of osteoarthritis of the knee
• Pain duration of >6 weeks and no previous knee surgeries
• Patients will also only be included who have never undergone a RFA on the affected knee

Exclusion Criteria:

• Individuals who do not have evidence of osteoarthritis on X-ray,
• Secondary gain expected to influence treatment outcomes
• Poorly controlled psychiatric condition that could affect outcome (e.g. active substance abuse) or impose a barrier to participation
• Chronic opioid use and anticoagulation therapy that cannot be stopped and could warrant a different treatment approach (e.g. phenol ablation)
• Severe motion sickness
• Seizure disorder
• Vision loss
• Pregnant
• Nursing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group #1: Virtual Reality Headset; Group 1 will be assigned to the Virtual Realtity Headset. Participants will wear the headset for at least 10 minutes prior to the planned procedure. Subjects will receive standard procedure. The VR Headset will be removed 10 minutes after the planned procedure.	Other: Experimental: Group #1: Virtual Reality Headset; Group 1 will be assigned to the Virtual Realtity Headset. Participants will wear the device for at least 10 minutes prior to the planned procedure. Subjects will receive standard procedure. The VR Headset will be removed 10 minutes after the planned procedure.
Active Comparator: Group 2 No Virtual Reality Headset; Group 2 will receive standard care without the use of the Virtuality Reality Headset.	Other: Group 2 No Virtual Reality Headset; Group 2 will receive standard care without the use of the Virtuality Reality Heaset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural related pain	Reported procedural related pain on a 0-10 verbal rating scale (VRS)	10 minutes after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure related satisfaction	Procedure related satisfaction on a 1-5 Likert scale (5=most satisfied, 1=least satisfied)	10 minutes after prodedure
Post procedure anxiety	Post-procedural numerical rating scale (NRS) for anxiety on an 11-point scale (0=no anxiety 10=worst possible level of anxiety)	10 minutes after procedure
Mean reduction in pain 1 month after procedure	Mean reduction on a 0-10 numerical rating scale (NRS) pain scores for average and worst knee pain at 1 month	30 days after procedure
Midazolam administered	Milligrams of midazolam administered during procedure for sedation	10 minutes before procedure to end of prodedure
Fentanyl administered	Micrograms of fentanyl administered during procedure	10 minutes before procedure to end of prodedure

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Jason Ross, MD, Northwestern Univesity

Publications and helpful links

General Publications

• Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
• Iannaccone F, Dixon S, Kaufman A. A Review of Long-Term Pain Relief after Genicular Nerve Radiofrequency Ablation in Chronic Knee Osteoarthritis. Pain Physician. 2017 Mar;20(3):E437-E444.
• Ding J, He Y, Chen L, Zhu B, Cai Q, Chen K, Liu G. Virtual reality distraction decreases pain during daily dressing changes following haemorrhoid surgery. J Int Med Res. 2019 Sep;47(9):4380-4388. doi: 10.1177/0300060519857862. Epub 2019 Jul 25.
• Hoffman HG, Richards TL, Van Oostrom T, Coda BA, Jensen MP, Blough DK, Sharar SR. The analgesic effects of opioids and immersive virtual reality distraction: evidence from subjective and functional brain imaging assessments. Anesth Analg. 2007 Dec;105(6):1776-83, table of contents. doi: 10.1213/01.ane.0000270205.45146.db.
• Conger A, Gililland J, Anderson L, Pelt CE, Peters C, McCormick ZL. Genicular Nerve Radiofrequency Ablation for the Treatment of Painful Knee Osteoarthritis: Current Evidence and Future Directions. Pain Med. 2021 Jul 25;22(Suppl 1):S20-S23. doi: 10.1093/pm/pnab129.
• Bair MJ, Wu J, Damush TM, Sutherland JM, Kroenke K. Association of depression and anxiety alone and in combination with chronic musculoskeletal pain in primary care patients. Psychosom Med. 2008 Oct;70(8):890-7. doi: 10.1097/PSY.0b013e318185c510. Epub 2008 Sep 16.
• Hsu H, Siwiec RM. Knee Osteoarthritis. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507884/

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Knee Pain; Pain; Virtual Reality; Radio Frequency Ablation; Genicular Nerve Block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: STU00220295

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No