NCT06336447 · Northwestern University
VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain
What this study is about
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.
View original scientific description
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.
Interventions
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.
OTHER
Group 2 No Virtual Reality Headset
Group 2 will receive standard care without the use of the Virtuality Reality Heaset.
Primary outcome measures
Procedural related pain
Time frame: 10 minutes after procedure
Reported procedural related pain on a 0-10 verbal rating scale (VRS)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 28, 2024 · Source of record for eligibility and locations