Virtual Reality for Musculoskeletal Pain

Overseen By Antonios Likourezos, MA, MPH

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Antonios Likourezos

Disqualifiers: Epilepsy, Seizure disorder, Vertigo, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 hours

180 Participants Needed

Trial Summary

How does this treatment differ from other treatments for musculoskeletal pain?

Virtual Reality (VR) treatment for musculoskeletal pain is unique because it offers a non-invasive, immersive experience that can distract patients from pain, promote cognitive behavioral changes, and enhance joint mobility. Unlike traditional treatments, VR can be used both in clinical and home settings, providing an engaging and interactive platform that may improve adherence to therapy. ^{1 2 3 4}

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.

Research Team

Sergey Motov, MD

Principal Investigator

Maimonides Medical Center

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

Emergency Medicine patients

Comprehension of informed consent process and study related content

I have a painful condition in my muscles or bones not caused by injury.

Exclusion Criteria

I have a seizure disorder.

Motion sickness

I am experiencing changes in my thinking or awareness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Standard of Care (SOC) or SOC plus Virtual Reality (VR) therapy for pain management

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for pain reduction, anxiety, stress, and adverse effects

2 hours

1 visit (in-person)

Treatment Details

Interventions

• Virtual Reality

Trial Overview 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.

Participant Groups

Group I: Standard of Care (SOC) Active Control 1 Intervention

Analgesia as determined by the treating physician

Group II: Virtual Reality (VR) + Standard of Care (SOC) Active Control 1 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

Who Is Running the Clinical Trial?

Antonios Likourezos

Lead Sponsor

Trials

41

Recruited

8,600+

Findings from Research

A scoping review of 14 randomized controlled trials found that virtual reality (VR) significantly alleviates pain and improves functional capacity in patients with chronic musculoskeletal disorders compared to standard care.

VR treatment also showed notable effectiveness in providing pain relief for burn patients with acute pain, but it was less effective for non-chronic pain conditions like total knee replacements or ankle sprains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of The Efficacy of Virtual Reality and Exergaming on Patients of Musculoskeletal System Disorder. Lin, HT., Li, YI., Hu, WP., et al.[2020]

Virtual Reality (VR) shows promise as a noninvasive therapy for both acute and chronic pain, potentially offering an alternative to traditional analgesics that often have side effects or are insufficient for chronic pain management.

Mechanisms of pain relief through VR include distraction and cognitive behavioral changes, with immersive experiences enhancing effectiveness, making it a viable option for conditions like complex regional pain syndrome and phantom limb pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of Virtual Reality as a Component of Acute and Chronic Pain Treatment]. Lindner, S., Latoschik, ME., Rittner, H.[2020]

Shoulder pain is a common issue that significantly impacts daily life, and while exercise is crucial for rehabilitation, the specific types and amounts of exercise needed are not well defined.

This study aims to explore physiotherapists' views on using virtual reality (VR) as a new tool for assessing and rehabilitating shoulder pain, potentially improving patient adherence to exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiotherapist beliefs and perspectives on virtual reality-supported rehabilitation for the assessment and management of musculoskeletal shoulder pain: a focus group study protocol. Brady, N., Lewis, J., McCreesh, K., et al.[2022]

A systematic review of 46 studies involving 1456 participants found that virtual, augmented, or mixed reality (VR/AR/MR) technology improved pain-related outcomes in 78% of randomized controlled trials (RCTs) for individuals with chronic pain.

Most positive effects were observed immediately or up to one month after treatment, highlighting the need for further RCTs to evaluate long-term benefits and accessibility for those facing pain management disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and efficacy of virtual, augmented, or mixed reality technology for chronic pain: a systematic review. Matthie, NS., Giordano, NA., Jenerette, CM., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Scoping Review of The Efficacy of Virtual Reality and Exergaming on Patients of Musculoskeletal System Disorder. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

[Use of Virtual Reality as a Component of Acute and Chronic Pain Treatment]. [2020]

3. Ireland pubmed.ncbi.nlm.nih.gov

Physiotherapist beliefs and perspectives on virtual reality-supported rehabilitation for the assessment and management of musculoskeletal shoulder pain: a focus group study protocol. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Use and efficacy of virtual, augmented, or mixed reality technology for chronic pain: a systematic review. [2023]