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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06336447
Status
Recruiting
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Conditions

  • Pain, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Experimental: Group #1: Virtual Reality Headset — OTHER
    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.
  • Group 2 No Virtual Reality Headset — OTHER
    Group 2 will receive standard care without the use of the Virtuality Reality Heaset.

Study Details

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.

Key Dates

Start date
Jan 12, 2024
Status verified
Mar 2024
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Procedural related pain [ Time Frame: 10 minutes after procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern Medicine Pain CenterChicagoIllinois60611
Paul Fitzgerald
[email protected]
312-695-1064
Jason Ross, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern Medicine Pain Center· Chicago, IL

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