VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain
NCT ID: NCT06336447
Last Updated: 2024-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
62 participants
INTERVENTIONAL
2024-01-12
2027-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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 Headset.
Group 2 No Virtual Reality Headset
Group 2 will receive standard care without the use of the Virtuality Reality Heaset.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Jason Ross
Principal Investigator
Principal Investigators
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Jason Ross, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern Univesity
Locations
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Northwestern Medicine Pain Center
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Hsu H, Siwiec RM. Knee Osteoarthritis. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507884/
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.
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.
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.
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.
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.
Other Identifiers
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STU00220295
Identifier Type: -
Identifier Source: org_study_id
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