Northwestern Medicine Pain Center
Chicago, Illinois, 60611, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06336447
VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Experimental: Group #1: Virtual Reality Headset
OtherGroup 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
OtherGroup 2 will receive standard care without the use of the Virtuality Reality Heaset.
Primary outcomes
-
Procedural related pain
Time frame: 10 minutes after procedure
Reported procedural related pain on a 0-10 verbal rating scale (VRS)
Secondary outcomes
-
Procedure related satisfaction
Time frame: 10 minutes after prodedure
Procedure related satisfaction on a 1-5 Likert scale (5=most satisfied, 1=least satisfied)
-
Post procedure anxiety
Time frame: 10 minutes after procedure
Post-procedural numerical rating scale (NRS) for anxiety on an 11-point scale (0=no anxiety 10=worst possible level of anxiety)
-
Mean reduction in pain 1 month after procedure
Time frame: 30 days after procedure
Mean reduction on a 0-10 numerical rating scale (NRS) pain scores for average and worst knee pain at 1 month
-
Midazolam administered
Time frame: 10 minutes before procedure to end of prodedure
Milligrams of midazolam administered during procedure for sedation
-
Fentanyl administered
Time frame: 10 minutes before procedure to end of prodedure
Micrograms of fentanyl administered during procedure
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Northwestern University
Other
Registry information
Official study 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
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Mar 28, 2024
- Registry last updated
- Mar 28, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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