VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain

Northwestern University

Status: Enrolling

Conditions: Pain, Chronic

Treatments: Other: Experimental: Group #1: Virtual Reality Headset; Other: Group 2 No Virtual Reality Headset

Study type: Interventional

Funder types: Other

Identifiers

NCT06336447

STU00220295

Details and patient eligibility

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.

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Group #1: Virtual Reality Headset

Experimental group

Description:

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.

Treatment:

Other: Experimental: Group #1: Virtual Reality Headset

Group 2 No Virtual Reality Headset

Active Comparator group

Description:

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

Treatment:

Other: Group 2 No Virtual Reality Headset