RecruitingNot ApplicableNCT06336447

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


Sponsor

Northwestern University

Enrollment

62 participants

Start Date

Jan 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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

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Interventions

OTHERExperimental: 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.

OTHERGroup 2 No Virtual Reality Headset

Group 2 will receive standard care without the use of the Virtuality Reality Heaset.


Locations(1)

Northwestern Medicine Pain Center

Chicago, Illinois, United States

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NCT06336447


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