Recruiting

VR & Cooled Genicular Nerve RFA

Sponsor:

Northwestern University

Code:

NCT06336447

Conditions

Pain, Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Experimental: Group #1: Virtual Reality Headset

Group 2 No Virtual Reality Headset

Study Details

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.

Conditions

Pain, Chronic

Study ID

NCT06336447

Start date

Jan 12, 2024

Status verified date

Mar, 2024

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Group 2 No Virtual Reality Headset

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Paul Fitzgerald, RN,BSN,MS

312-695-1064p-fitzgerald2@northwestern.edu

Locations

Northwestern Medicine Pain Center

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Paul Fitzgerald

312-695-1064p-fitzgerald2@northwestern.edu

Principal Investigator:

Jason Ross, MD

More Information

Sponsor

Northwestern University

Last update posted

Mar 28, 2024

Last verified

Mar, 2024

Keywords

  • Pain
  • Knee Pain
  • Virtual Reality
  • Radio Frequency Ablation
  • Genicular Nerve Block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2024-03-28.