Effect of VR on Pain and Patient Satisfaction in Adults Receiving GNRFA

Pain Clinical Trial

Official title:

The Effect of Virtual Reality on Pain and Patient Satisfaction in Adults Receiving Genicular Nerve Radiofrequency Ablation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05468398
• Other study ID #: 20206207
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: January 30, 2025

Study information

• Verified date: March 2024
• Source: University of California, Irvine
• Contact: Navid Alem, MD
• Phone: (949) 413-4950
• Email: alemn[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 67
• Est. completion date: January 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain
• Patient Satisfaction

Intervention

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.

Locations

Country	Name	City	State
United States	UC Irvine Gottschalk Medical Plaza	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Applied VR

Country where clinical trial is conducted

United States, 

References & Publications (14)

Alaterre C, Duceau B, Sung Tsai E, Zriouel S, Bonnet F, Lescot T, Verdonk F. Virtual Reality for PEripheral Regional Anesthesia (VR-PERLA Study). J Clin Med. 2020 Jan 13;9(1):215. doi: 10.3390/jcm9010215. — View Citation

Carrougher GJ, Hoffman HG, Nakamura D, Lezotte D, Soltani M, Leahy L, Engrav LH, Patterson DR. The effect of virtual reality on pain and range of motion in adults with burn injuries. J Burn Care Res. 2009 Sep-Oct;30(5):785-91. doi: 10.1097/BCR.0b013e3181b485d3. — View Citation

Chan PY, Scharf S. Virtual Reality as an Adjunctive Nonpharmacological Sedative During Orthopedic Surgery Under Regional Anesthesia: A Pilot and Feasibility Study. Anesth Analg. 2017 Oct;125(4):1200-1202. doi: 10.1213/ANE.0000000000002169. — View Citation

Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129. — View Citation

Hoffman HG, Seibel EJ, Richards TL, Furness TA, Patterson DR, Sharar SR. Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. J Pain. 2006 Nov;7(11):843-50. doi: 10.1016/j.jpain.2006.04.006. — View Citation

Hong T, Wang H, Li G, Yao P, Ding Y. Systematic Review and Meta-Analysis of 12 Randomized Controlled Trials Evaluating the Efficacy of Invasive Radiofrequency Treatment for Knee Pain and Function. Biomed Res Int. 2019 Jun 26;2019:9037510. doi: 10.1155/2019/9037510. eCollection 2019. — View Citation

Jamison DE, Cohen SP. Radiofrequency techniques to treat chronic knee pain: a comprehensive review of anatomy, effectiveness, treatment parameters, and patient selection. J Pain Res. 2018 Sep 18;11:1879-1888. doi: 10.2147/JPR.S144633. eCollection 2018. — View Citation

Kidd VD, Strum SR, Strum DS, Shah J. Genicular Nerve Radiofrequency Ablation for Painful Knee Arthritis: The Why and the How. JBJS Essent Surg Tech. 2019 Mar 13;9(1):e10. doi: 10.2106/JBJS.ST.18.00016. eCollection 2019 Mar 26. — View Citation

Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8. — View Citation

McCaul KD, Malott JM. Distraction and coping with pain. Psychol Bull. 1984 May;95(3):516-33. No abstract available. — View Citation

Mosso JL, Gorini A, De La Cerda G, Obrador T, Almazan A, Mosso D, Nieto JJ, Riva G. Virtual reality on mobile phones to reduce anxiety in outpatient surgery. Stud Health Technol Inform. 2009;142:195-200. — View Citation

Sharar SR, Carrougher GJ, Nakamura D, Hoffman HG, Blough DK, Patterson DR. Factors influencing the efficacy of virtual reality distraction analgesia during postburn physical therapy: preliminary results from 3 ongoing studies. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S43-9. doi: 10.1016/j.apmr.2007.09.004. — View Citation

Sikka N, Shu L, Ritchie B, Amdur RL, Pourmand A. Virtual Reality-Assisted Pain, Anxiety, and Anger Management in the Emergency Department. Telemed J E Health. 2019 Dec;25(12):1207-1215. doi: 10.1089/tmj.2018.0273. Epub 2019 Feb 20. — View Citation

Spiegel B, Fuller G, Lopez M, Dupuy T, Noah B, Howard A, Albert M, Tashjian V, Lam R, Ahn J, Dailey F, Rosen BT, Vrahas M, Little M, Garlich J, Dzubur E, IsHak W, Danovitch I. Virtual reality for management of pain in hospitalized patients: A randomized comparative effectiveness trial. PLoS One. 2019 Aug 14;14(8):e0219115. doi: 10.1371/journal.pone.0219115. eCollection 2019. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Pain During Procedure	The pain score identified intensity on a 0-100 point Graphic Rating Scale questioning worst pain during the genicular RFA procedure with 0=not satisfied and 100= very satisfied	20 minutes
Primary	Patient Satisfaction with VR Device	Identified intensity on a 0-100 Graphic Rating Scale questioning overall satisfaction during genicular RFA procedure with 0=not satisfied and 100= very satisfied	20 minutes
Secondary	Pain Thoughts: Duration of Time Patient Spent Thinking of Pain	identified intensity on a 0-100 point Graphic Rating Scale questioning worst pain during the genicular RFA procedure with 0=not satisfied and 100= very satisfied	20 minutes
Secondary	Patient Procedural Anxiety	Patient asked pre and periprocedurally, their anxiety level; measured by a 0-10 Graphic Rating scale questioning anxiety before and during procedur with 0=not anxious and 10=very anxious	20 minutes
Secondary	Provider Satisfaction During Procedure	Practitioners' satisfaction with the VR will be assessed via a 0-100 point Graphic Rating Scale with 0=not satisfied and 100=very satisfied	20 minutes
Secondary	Additional Local Anesthetic	Needs to Utilize Additional Local Anesthetic	20 minutes
Secondary	Provider Pain Perception of Patient's Pain	Need for provider to utilized additional local anesthetic as measured by yes/n o and amount of additional local anesthetic utilized	20 minutes
Secondary	Prior Knee Radiofrequency Ablation	Yes/No question if patient has had a previous RFA procedure prior to study visit	2 years
Secondary	Prior Virtual Reality Use	Yes/No question if patient has used VR of any kind in the past (such as for gaming, etc.)	2 years
Secondary	Side Effects of Virtual Reality	Patient will be asked if they had any side effects such as headache, palpitations, etc. when using the VR	20 minutes
Secondary	Subgroup Analysis	Analysis of Patients by Age, Gender, Provider, and Technology Acceptance; reviewing demographic information across patients to determine commonalities	1 year

External Links

•   Applied VR Research Studies