Pain, Patient Satisfaction
Conditions
Keywords
Genicular Nerve Block, Virtual Reality, Genicular Nerve Radiofrequency Ablation, GNRFA
Brief summary
The study team aims to investigate whether implementing virtual reality therapy (VRT) during Genicular nerve radiofrequency ablation (GNRFA) procedure will provide better alleviation of procedural pain and augmented satisfaction for patients.
Detailed description
Patients' experience through a medical procedure in a hospital environment is inherently stressful and painful. Although virtual reality (VR) was originally recognized for its entertainment value, it has recently been used as an innovative tool in clinical settings to reduce pain and anxiety, while improving patient satisfaction. VR is a computer generated simulation of a life-like experience that usually serves people for entertainment and social interactive purposes in a simulated three-dimensional environment. Virtual reality therapy (VRT) offers patients an opportunity to "get away" from noxious stimuli as they draw their attention towards another virtual world (Alem). Virtual reality provides a cognitive distraction through creating a "real world illusion." VR may deter an individual's attention from pain as it offers a multimodal sensory distractor. This positive experience may result in reduction of pain score by decreasing the time patients think about their pain during a procedure. Genicular nerve radiofrequency ablation (GNRFA) is an option to treat knee pain without surgery. The genicular nerves are the nerves that feed into the knee. Radiofrequency ablation is a process by applying radiofrequency waves to the nerves that are carrying the painful impulses from the knee joint. GNRFA uses fluoroscopy guidance to introduce 3 needles at each of the three genicular nerves which transmit sensation from the knee joint. This is followed by testing for sensory response, followed by administration of local anesthetic (2% lidocaine) per standard-of-care, and then radiofrequency ablation. This method of treatment is known to be very safe, convenient and reliable because fluoroscopy guidance provides high accuracy of localization at the procedure targets outside of the knee joint. Patients with symptomatic knee osteoarthritis have shown short and long term positive results following this method with significant reduction of pain levels (Kidd) and augmented functionality. This non-invasive procedure is able to successfully replace surgery or intra-articular therapy where the procedure is conducted directly on the knee joint.
Interventions
DEVICESoothe VR
The Soothe VR system is manufactured by Applied VR. It is a HIPAA-compliant platform and has been validated by randomized control trials. It has not yet been reviewed by the FDA.
Sponsors
University of California, Irvine
Applied VR
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This was a single-center, non-blinded, randomized controlled trial with a parallel assignment design. Participants were randomly allocated in a 1:1 ratio to receive either standard care alone or standard care with immersive virtual reality (VR) therapy during genicular nerve radiofrequency ablation (GNRFA). The intervention was administered during the procedure only. The study aimed to assess the impact of VR on patient-reported pain, anxiety, satisfaction, and physician-rated procedural outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 18 or older * Patients Undergoing a genicular nerve radiofrequency ablation * Patients who have previously received nerve blocks or radiofrequency ablation procedures may be included
Exclusion criteria
* Requiring sedation during procedure * Cognitive impairment or dementia * History of recent stroke, epilepsy, psychosis, or claustrophobia * Blindness or deafness * Refusal to use the headset * Isolation status for infection control * Motion sickness or active nausea/vomit * Pregnancy (Pregnancy testing point of care available for females of child bearing age)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Pain Intensity During Genicular RFA Procedure | 20 minutes | Peak pain intensity experienced by participants during the genicular RFA procedure was assessed using a Visual Analog Scale (VAS) from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate greater pain intensity (worse outcome). |
| Patient Satisfaction With VR Device | Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation) | Patient satisfaction with the Virtual Reality (VR) device during the genicular radiofrequency ablation (RFA) procedure was assessed using a Visual Analog Scale (VAS). Participants rated their overall satisfaction immediately following the procedure on a continuous scale ranging from 0 (not satisfied at all) to 100 (extremely satisfied). Higher scores indicate greater satisfaction, representing a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Anxiety During Genicular RFA Procedure | During the genicular RFA procedure (approximately 20 minutes) | Patient anxiety during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 VAS. Patients rated their anxiety level during the procedure only, from 0 ("not anxious at all") to 100 ("extremely anxious"). Higher scores indicate a worse outcome (greater anxiety). |
| Provider Satisfaction During Procedure | Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation) | Practitioners' satisfaction with the Virtual Reality (VR) device during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 satisfaction VAS. Providers rated their overall satisfaction immediately following completion of the procedure, from 0 ("not satisfied at all") to 100 ("extremely satisfied"). Higher scores indicate greater satisfaction, representing a better outcome. |
| Use of Additional Local Anesthetic During Genicular RFA Procedure | During the genicular RFA procedure (approximately 20 minutes) | The need for additional local anesthetic administration during the genicular radiofrequency ablation (RFA) procedure was assessed as a binary outcome (Yes/No). Providers recorded whether additional local anesthetic was administered beyond the standard initial dose during the procedure. |
| Provider Perception of Patient's Pain During Genicular RFA Procedure | During the genicular RFA procedure (approximately 20 minutes) | Provider's perception of the patient's pain during the genicular RFA procedure was assessed using a 0-100 VAS. Providers rated their perception of patient pain from 0 ("no perceived pain") to 100 ("extremely severe pain"). Higher scores indicate a worse outcome (higher perceived patient pain). |
| Prior Knee Radiofrequency Ablation | Assessed at baseline (participant history of knee RFA within the past 2 years) | Participants were asked if they had undergone a previous knee radiofrequency ablation (RFA) procedure prior to the study intervention. Responses were recorded as binary outcomes (Yes/No). |
| Prior Experience With Virtual Reality (VR) | Assessed at baseline (participant history of VR use within the past 2 years) | Participants reported if they had previously used Virtual Reality (VR) technology for any reason (e.g., gaming, therapy) before participation in the study. Responses were recorded as binary outcomes (Yes/No). |
| Side Effects Associated With Virtual Reality During Genicular RFA Procedure | Immediately post-procedure (approximately 20 minutes after procedure initiation) | Participants were asked immediately after the procedure if they experienced any side effects related to the use of Virtual Reality (VR), such as headache, dizziness, nausea, or palpitations. Responses were recorded as binary outcomes (Yes/No). |
| Duration of Time Spent Thinking About Pain During Genicular RFA Procedure | During genicular RFA procedure (intra-procedural) | This outcome was pre-specified in the study protocol but was not collected during the study due to an omission in data collection implementation. As a result, no data are available for this outcome, and it was not analyzed. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNavid Alem, MD
Faculty
Participant flow
Recruitment details
Participants were recruited at University of California, Irvine Health's Gottschalk Medical Plaza between December 2020 and September 2024. Due to study scope and completion of planned enrollment, the study closed with 40 enrolled participants.
Pre-assignment details
Of the 40 participants who consented, all were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Control The control group will receive a genicular RFA with local anesthetic as per the standard-of-care | 18 |
| VR Intervention The VR Intervention group will receive a genicular RFA with local anesthetic as per the standard-of-care and the use of the Soothe VR device.
Soothe VR: The Soothe VR system is manufactured by Applied VR. It is a HIPAA-compliant platform and has been validated by randomized control trials. It has not yet been reviewed by the FDA. | 22 |
| Total | 40 |
Baseline characteristics
| Characteristic | Control | VR Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 19 Participants | 36 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Continuous | 73.2 years STANDARD_DEVIATION 5.2 | 70.6 years STANDARD_DEVIATION 8.5 | 71.9 years STANDARD_DEVIATION 7.1 |
| Baseline pain intensity was measured using the Visual Analog Scale (VAS) | 71.8 units on a scale STANDARD_DEVIATION 23.04 | 64.4 units on a scale STANDARD_DEVIATION 23.5 | 67.7 units on a scale STANDARD_DEVIATION 22.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Female | 14 Participants | 11 Participants | 25 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Patient Satisfaction With VR Device
Patient satisfaction with the Virtual Reality (VR) device during the genicular radiofrequency ablation (RFA) procedure was assessed using a Graphic Rating Scale (GRS). Participants rated their overall satisfaction immediately following the procedure on a continuous scale ranging from 0 (not satisfied at all) to 100 (extremely satisfied). Higher scores indicate greater satisfaction, representing a better outcome.
Time frame: Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation)
Population: Only participants in the VR group completed the satisfaction survey. All 22 participants in this group were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Patient Satisfaction With VR Device | 87.7 units on a 0 -100 scale | Standard Deviation 15.6 |
Primary
Peak Pain Intensity During Genicular RFA Procedure
Peak pain intensity experienced by participants during the genicular RFA procedure was assessed using a Graphic Rating Scale (GRS) from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate greater pain intensity (worse outcome).
Time frame: 20 minutes
Population: All participants who completed both the pre- and post-procedure pain assessments were included in this analysis (n=40). Pain score reduction was calculated as the difference between pre- and post-procedure VAS scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Peak Pain Intensity During Genicular RFA Procedure | 78.17 units on a scale | Standard Deviation 18.25 |
| VR Intervention | Peak Pain Intensity During Genicular RFA Procedure | 68.17 units on a scale | Standard Deviation 24 |
Secondary
Duration of Time Patient Spent Thinking About Pain During Genicular RFA Procedure
The duration or proportion of time patients spent thinking about their pain during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 Graphic Rating Scale (GRS). Participants rated how much time they spent thinking about pain during the procedure, with scores ranging from 0 (no time thinking about pain) to 100 (entire procedure spent thinking about pain). Higher scores indicate a worse outcome (greater proportion of procedure time spent thinking about pain).
Time frame: During the genicular RFA procedure (approximately 20 minutes)
Secondary
Patient Anxiety During Genicular RFA Procedure Patient Anxiety During Genicular RFA Procedure Patient Anxiety During Genicular RFA Procedure
Patient anxiety during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 Graphic Rating Scale (GRS). Patients rated their anxiety level during the procedure only, from 0 (not anxious at all) to 100 (extremely anxious). Higher scores indicate a worse outcome (greater anxiety).
Time frame: During the genicular RFA procedure (approximately 20 minutes)
Population: All 40 participants (22 in the VR group, 18 in the control group) completed the anxiety question during the procedure and were included in this analysis. Anxiety was measured using a 0-100 Graphic Rating Scale, with higher scores indicating greater anxiety.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Patient Anxiety During Genicular RFA Procedure Patient Anxiety During Genicular RFA Procedure Patient Anxiety During Genicular RFA Procedure | 71.17 Units on a 0-100 scale | Standard Deviation 23.15 |
| VR Intervention | Patient Anxiety During Genicular RFA Procedure Patient Anxiety During Genicular RFA Procedure Patient Anxiety During Genicular RFA Procedure | 51.4 Units on a 0-100 scale | Standard Deviation 26.13 |
Secondary
Prior Experience With Virtual Reality (VR)
Participants reported if they had previously used Virtual Reality (VR) technology for any reason (e.g., gaming, therapy) before participation in the study. Responses were recorded as binary outcomes (Yes/No).
Time frame: Assessed at baseline (participant history of VR use within the past 2 years)
Secondary
Prior Knee Radiofrequency Ablation
Participants were asked if they had undergone a previous knee radiofrequency ablation (RFA) procedure prior to the study intervention. Responses were recorded as binary outcomes (Yes/No).
Time frame: Assessed at baseline (participant history of knee RFA within the past 2 years)
Secondary
Provider Perception of Patient's Pain During Genicular RFA Procedure
Provider's perception of the patient's pain during the genicular RFA procedure was assessed using a 0-100 Graphic Rating Scale (GRS). Providers rated their perception of patient pain from 0 (no perceived pain) to 100 (extremely severe pain). Higher scores indicate a worse outcome (higher perceived patient pain).
Time frame: During the genicular RFA procedure (approximately 20 minutes)
Population: Ratings were based on provider observation and recorded using a 0-100 Graphic rating Scale, where higher scores indicate greater perceived patient pain.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Provider Perception of Patient's Pain During Genicular RFA Procedure | 71.11 Units on a 0-100 Scale | Standard Deviation 18.5 |
| VR Intervention | Provider Perception of Patient's Pain During Genicular RFA Procedure | 36.74 Units on a 0-100 Scale | Standard Deviation 21.67 |
Secondary
Provider Satisfaction During Procedure
Practitioners' satisfaction with the Virtual Reality (VR) device during the genicular radiofrequency ablation (RFA) procedure was assessed using a 0-100 Graphic Rating Scale (GRS). Providers rated their overall satisfaction immediately following completion of the procedure, from 0 (not satisfied at all) to 100 (extremely satisfied). Higher scores indicate greater satisfaction, representing a better outcome.
Time frame: Immediately post-genicular RFA procedure (approximately 20 minutes after procedure initiation)
Population: Practitioners rated their satisfaction with the procedure using a 0-100 Graphic Rating Scale. Higher scores indicate greater satisfaction. Surveys were completed after each procedure based on the provider's experience with patient behavior and ease of the procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Provider Satisfaction During Procedure | 61.25 Units on a 0-100 scale | Standard Deviation 24 |
| VR Intervention | Provider Satisfaction During Procedure | 87.9 Units on a 0-100 scale | Standard Deviation 15.25 |
Secondary
Side Effects Associated With Virtual Reality During Genicular RFA Procedure
Participants were asked immediately after the procedure if they experienced any side effects related to the use of Virtual Reality (VR), such as headache, dizziness, nausea, or palpitations. Responses were recorded as binary outcomes (Yes/No).
Time frame: Immediately post-procedure (approximately 20 minutes after procedure initiation)
Secondary
Subgroup Analysis by Age, Gender, Provider, and Technology Acceptance
A descriptive subgroup analysis of participants was conducted to identify commonalities in response and acceptance of technology across demographic characteristics including age, gender, provider type, and general acceptance of technology.
Time frame: Assessed at baseline (demographic information collected at enrollment)
Secondary
Use of Additional Local Anesthetic During Genicular RFA Procedure
The need for additional local anesthetic administration during the genicular radiofrequency ablation (RFA) procedure was assessed as a binary outcome (Yes/No). Providers recorded whether additional local anesthetic was administered beyond the standard initial dose during the procedure.
Time frame: During the genicular RFA procedure (approximately 20 minutes)