Trial Summary
What is the purpose of this trial?The proposed Virtual Reality as an Adjunct to Pain Management for Geriatric Patients in the ED (VRAP-ED) project will take place in the Emergency Medicine Department at Maimonides Medical Center. It seeks to enhance the analgesic practices for geriatric patients with acute painful conditions in the emergency setting. Although virtual reality (VR) has demonstrated effectiveness in reducing pain and anxiety in various clinical settings for juveniles and adults, the analgesic efficacy of VR for geriatric ED patients lacks established data. The project will use a geriatric-focused VR platform.
The project intends to improve pain management for almost 200 geriatric patients by evaluating the effectiveness of virtual reality (VR) in reducing pain and its impact on anxiety \& stress reduction. The research project will conduct a randomized clinical trial to investigate the analgesic efficacy and impact on anxiety \& stress by using VR as an adjunct to the standard of care (SOC) for pain management in elderly patients presenting to the ED with acute musculoskeletal pain. This will be investigated through a prospective, randomized, non-blinded clinical trial conducted over two years. Eligible patients will be randomly assigned to either the control (SOC) or intervention (SOC+VR) groups. The expected outcomes of this research study will provide insight into the feasibility of using VR in a busy emergency setting for one of the most commonly encountered painful syndromes and to assess the analgesic efficacy as well as the satisfaction of VR application by both patients and ED clinicians.
Is Virtual Reality a promising treatment for musculoskeletal pain?Yes, Virtual Reality is a promising treatment for musculoskeletal pain. It can significantly relieve pain, improve movement, and increase joint flexibility, especially for chronic conditions. It also helps in managing acute pain, like burns, by providing a non-drug therapy option that can be used at home or in clinical settings.1234
Eligibility Criteria
This trial is for geriatric patients aged 65 or older in the emergency department with acute non-traumatic musculoskeletal pain, scoring at least a 4 on the pain scale. Participants must understand the study and be alert. They should require parenteral analgesia as determined by their doctor and be able to complete assessments.Inclusion Criteria
I am 65 years old or older.
I have a painful condition in my muscles or bones not caused by injury.
My pain level is 4 or higher on a scale of 0-10.
Exclusion Criteria
I am experiencing changes in my thinking or awareness.
I am currently experiencing a headache.
I have a seizure disorder.
I need immediate treatment for severe pain.
My vital signs are stable.
I have had epilepsy recently.
I experience dizziness.
Treatment Details
The trial is testing if adding Virtual Reality (VR) to standard care can better manage pain for elderly emergency department patients compared to standard care alone. It's a randomized study where participants are put into either the control group receiving only standard care or an intervention group getting VR plus standard care.
2Treatment groups
Active Control
Group I: Standard of Care (SOC)Active Control1 Intervention
Analgesia as determined by the treating physician
Group II: Virtual Reality (VR) + Standard of Care (SOC)Active Control1 Intervention
Analgesia as determined by the treating physician and Virtual Reality experience that will use a geriatric-focused VR platform that has age appropriate VR content and will run for approximately 5-10 minutes
Find a clinic near you
Research locations nearbySelect from list below to view details:
Maimonides Medical CenterBrooklyn, NY
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Who is running the clinical trial?
Antonios LikourezosLead Sponsor
References
A Scoping Review of The Efficacy of Virtual Reality and Exergaming on Patients of Musculoskeletal System Disorder. [2020]To assess the effects of virtual reality on patients with musculoskeletal disorders by means of a scoping review of randomized controlled trials (RCTs). The databases included PubMed, IEEE, and the MEDLINE database. Articles involving RCTs with higher than five points on the Physiotherapy Evidence Database (PEDro) scale were reviewed for suitability and inclusion. The methodological quality of the included RCT was evaluated using the PEDro scale. The three reviewers extracted relevant information from the included studies. Fourteen RCT articles were included. When compared with simple usual care or other forms of treatment, there was significant pain relief, increased functional capacity, reduced symptoms of the disorder, and increased joint angles for the virtual reality treatment of chronic musculoskeletal disorders. Furthermore, burn patients with acute pain were able to experience a significant therapeutic effect on pain relief. However, virtual reality treatment of patients with non-chronic pain such as total knee replacement, ankle sprains, as well as those who went through very short virtual reality treatments, did not show a significant difference in parameters, as compared with simple usual care and other forms of treatment. Current evidence supports VR treatment as having a significant effect on pain relief, increased joint mobility, or motor function of patients with chronic musculoskeletal disorders. VR seems quite effective in relieving the pain of patients with acute burns as well.
[Use of Virtual Reality as a Component of Acute and Chronic Pain Treatment]. [2020]Future or reality? Treating acute and chronic pain is a part of the daily routine of clinical anesthesiologists. Commonly used analgesics have unwanted side effects or may even be insufficient as in chronic pain treatment. Virtual Reality (VR) could be a promising new approach which offers noninvasive therapy options for the treatment of pain. In case of the opioid misuse the adjunctive treatment is mandatory. Various phenomena occur in VR, such as immersion, presence, embodiment and Proteus effect, which can cause a change in body awareness and behavior. Experimental and clinical studies already yielded some promising results for analgesic effects for acute and chronic pain conditions using VR simulation. Potential analgesic mechanisms include distraction, cognitive behavioral change, and distance from reality, leading to neurophysiological changes at the cortical level. The quality of the virtual environment, personalized avatars, as well as the possibility of interaction and multisensory input can increase immersion, which leads to a state of presence, and thus effective VR. VR can be used as an immersive extension or alternative to mirror therapy, especially for pain disorders such as complex regional pain syndrome (CRPS) or phantom limb pain. VR can be supplemented by gamification, which increases intrinsic motivation, well-being and adherence to therapy. In summary, VR could be an effective and realistic therapy option for acute and chronic pain in clinical and home settings in the future.
Physiotherapist beliefs and perspectives on virtual reality-supported rehabilitation for the assessment and management of musculoskeletal shoulder pain: a focus group study protocol. [2022]Shoulder pain accounts for a large proportion of musculoskeletal disorders and years lived with disability. Musculoskeletal shoulder pain is challenging to manage and while research evidence suggests that exercise should be a cornerstone of shoulder pain rehabilitation, the exact type and dosage of exercise is unclear. Adherence is a barrier to successful outcomes with exercise-based management of musculoskeletal pain, especially for those with co-morbidities, high pain levels and reported boredom associated with competing prescribed exercise. Virtual reality (VR) may offer an effective platform for rehabilitation of musculoskeletal shoulder pain. Virtual Reality has been shown to be effective for management of acute and chronic pain conditions, for delivering education around various health conditions, and for supporting rehabilitation of neurological conditions. Therefore, it is possible that VR may have a role in the delivery of exercise and education for individuals with musculoskeletal shoulder pain. VR intervention design should involve several steps and begin with establishing early acceptability from users as to the suitability of the technology in clinical practice as well as potential barriers and facilitators to using the technology successfully. This study will therefore aim to explore physiotherapists beliefs and perspectives of immersive VR as a platform for assessment and rehabilitation in patients with musculoskeletal shoulder pain. Further, this study will inform the development of a VR intervention for use in the rehabilitation of musculoskeletal shoulder pain. A series of online focus groups will be conducted with physiotherapists in Ireland using a qualitative descriptive approach to data analysis. A six-phase process of data analysis will be carried out to identify important patterns and themes within the data. The current study will be the first to explore clinician's perspectives on the role of VR in musculoskeletal practice.
Use and efficacy of virtual, augmented, or mixed reality technology for chronic pain: a systematic review. [2023]Aim: Characterize use and efficacy/effectiveness of virtual, augmented, or mixed reality (VR/AR/MR) technology as non-pharmacological therapy for chronic pain. Methods: Systematic search of 12 databases to identify empirical studies, of individuals who experience chronic pain or illness involving chronic pain, published between 1990 and 2021. JBI Critical Appraisal Checklists assessed study bias and a narrative synthesis was provided. Results: 46 studies, investigating a total of 1456 participants and including 19 randomized controlled trials (RCT), were reviewed. VR/AR/MR was associated with improved pain-related outcomes in 78% of the RCTs. Conclusion: While most studies showed effects immediately or up to one month post treatment, RCTs are needed to further evaluate VR/AR/MR, establish long-term benefits, and assess accessibility, especially among individuals who experience pain management disparities.