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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized controlled trail.
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Outcome assessor will be blinded to study randomization

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • 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.
Active Comparator
Group 2 No Virtual Reality Headset 		Group 2 will receive standard care without the use of the Virtuality Reality Headset.
  • Other: Group 2 No Virtual Reality Headset
    Group 2 will receive standard care without the use of the Virtuality Reality Heaset.

Recruiting Locations

Northwestern Medicine Pain Center
Chicago, Illinois 60611
Contact:
Paul Fitzgerald
312-695-1064
p-fitzgerald2@northwestern.edu

More Details

Status
Recruiting
Sponsor
Northwestern University

Study Contact

Paul Fitzgerald, RN,BSN,MS
312-695-1064
p-fitzgerald2@northwestern.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.