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

Not Applicable

Recruiting

• Conditions: Pain, Chronic
• Interventions: Other: Group 2 No Virtual Reality Headset

• Registration Number: NCT06336447
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-12
• Status Verified: 2024-03
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-28
• Last Update Posted: 2024-03-28
• Primary Completion: 2026-12-31
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 No Virtual Reality Headset	Group 2 No Virtual Reality Headset	Group 2 will receive standard care without the use of the Virtuality Reality Headset.

Primary Outcome Measures

Name	Time	Method
Procedural related pain	10 minutes after procedure	Reported procedural related pain on a 0-10 verbal rating scale (VRS)

Secondary Outcome Measures

Name	Time	Method
Procedure related satisfaction	10 minutes after prodedure	Procedure related satisfaction on a 1-5 Likert scale (5=most satisfied, 1=least satisfied)
Post procedure anxiety	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	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	10 minutes before procedure to end of prodedure	Milligrams of midazolam administered during procedure for sedation
Fentanyl administered	10 minutes before procedure to end of prodedure	Micrograms of fentanyl administered during procedure

Trial Locations

Locations (1)

Northwestern Medicine Pain Center; 🇺🇸 Chicago, Illinois, United States