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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Procedural related pain [Срок оценки: 10 minutes after procedure]

Вторичные конечные точки (5)

• Procedure related satisfaction [Срок оценки: 10 minutes after prodedure]
• Post procedure anxiety [Срок оценки: 10 minutes after procedure]
• Mean reduction in pain 1 month after procedure [Срок оценки: 30 days after procedure]
• Midazolam administered [Срок оценки: 10 minutes before procedure to end of prodedure]
• Fentanyl administered [Срок оценки: 10 minutes before procedure to end of prodedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Northwestern Medicine Pain Center — Chicago

Публикации

• 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. PMID 24553908
• Hsu H, Siwiec RM. Knee Osteoarthritis. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507884/ PMID 29939661
• 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. PMID 34308957
• 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. PMID 28339444
• 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. PMID 18042882
• 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. PMID 31342823
• 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. PMID 18799425

Идентификаторы

NCT: NCT06336447 · STU00220295

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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