Clinical trial NCT06336447: VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Chronic
Keywords: Pain
Knee Pain
Virtual Reality
Radio Frequency Ablation
Genicular Nerve Block
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trail.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Procedural related pain
timeFrame: 10 minutes after procedure
Secondary outcomes:
measure: Procedure related satisfaction
timeFrame: 10 minutes after prodedure
measure: Post procedure anxiety
timeFrame: 10 minutes after procedure
measure: Mean reduction in pain 1 month after procedure
timeFrame: 30 days after procedure
measure: Midazolam administered
timeFrame: 10 minutes before procedure to end of prodedure
measure: Fentanyl administered
timeFrame: 10 minutes before procedure to end of prodedure
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine Pain Center
state: Illinois
Study officials:
affiliation: Northwestern Univesity
name: Jason Ross, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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/
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.
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.
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.
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.
citation: 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.