Pain, Chronic
Conditions
Keywords
Pain, Knee Pain, Virtual Reality, Radio Frequency Ablation, Genicular Nerve Block
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.
Interventions
OTHERExperimental: 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.
OTHERGroup 2 No Virtual Reality Headset
Group 2 will receive standard care without the use of the Virtuality Reality Heaset.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor will be blinded to study randomization
Intervention model description
Randomized controlled trail.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural related pain | 10 minutes after procedure | Reported procedural related pain on a 0-10 verbal rating scale (VRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactPaul Fitzgerald, RN,BSN,MS
Outcome results
None listed