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

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336447
• Other study ID #: STU00220295
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Paul Fitzgerald, RN,BSN,MS
• Phone: 312-695-1064
• Email: p-fitzgerald2[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: February 28, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

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.
• Group 2 No Virtual Reality Headset
Group 2 will receive standard care without the use of the Virtuality Reality Heaset.

Locations

Country	Name	City	State
United States	Northwestern Medicine Pain Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/ — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural related pain	Reported procedural related pain on a 0-10 verbal rating scale (VRS)	10 minutes after procedure
Secondary	Procedure related satisfaction	Procedure related satisfaction on a 1-5 Likert scale (5=most satisfied, 1=least satisfied)	10 minutes after prodedure
Secondary	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
Secondary	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
Secondary	Midazolam administered	Milligrams of midazolam administered during procedure for sedation	10 minutes before procedure to end of prodedure
Secondary	Fentanyl administered	Micrograms of fentanyl administered during procedure	10 minutes before procedure to end of prodedure