Acute Musculoskeletal PainNCT06685107
Virtual Reality and Standard Care vs. Standard Care Alone for Acute MSK Pain in Geriatric ED Patients
A study of Acute Musculoskeletal Pain, run by Antonios Likourezos at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 120 years
- Conditions the study is for
- Acute Musculoskeletal Pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age of 65+
- Emergency Medicine patients
- non traumatic musculoskeletal painful condition
- pain score of 4+ on the numeric rating scale
- patient will warrant parenteral analgesia per treating physician
- patient will have to be awake, alert, and oriented to person, place, and time.
- comprehension of informed consent process and study related content
- ability to complete assessments
Who cannot join
- painful syndrome requiring emergent and/or urgent pain control
- altered mental status
- unstable vital signs
- history of recent epilepsy
- seizure disorder
- vertigo
Show all 10Show fewer
- active headache
- nausea
- motion sickness
- dizziness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Antonios Likourezos, MA, MPH contact
United States1 site, 1 recruiting
- Recruiting
Maimonides Medical Center
Brooklyn, New York, 11219
Sergey Motov, MD, smotov@maimo.org
Antonios Likourezos, MPH, alikourezos@maimo.org
About this study
Official title: Combination of Virtual Reality and Standard of Care Versus Standard of Care Alone for Acute Musculoskeletal Pain Management in Geriatric Emergency Department Patients: A Randomized Clinical 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.
Read the detailed description
The investigators will conduct a prospective, randomized, non-blinded clinical trial, over a 2-year period, to investigate the efficacy of virtual reality (VR) on pain reduction as a primary outcome (quantitative outcome) and its effect on anxiety and stress (qualitative outcomes) as secondary outcomes in geriatric patients presenting to the ED of Maimonides Medical Center. This clinical trial will focus on patients with complaints of acute traumatic and non-traumatic musculoskeletal pain. These patients will be screened for eligibility and approached by study investigators. Upon meeting the eligibility criteria and completing an informed consent form, patients will be randomized into one of two study groups: 1) Standard of Care or 2) Standard of Care (SOC) plus Virtual Reality. Subjects will include geriatric patients, ages 65 and older, presenting to the ED with acute traumatic and non-traumatic musculoskeletal (MSK) painful syndromes with an initial numeric pain score of 4 and above on a standard 11 point (0 to 10) numeric rating scale (NRS) and requiring analgesia as determined by the treating ED physician. The total sample size for this trial will be 180 subjects (90 per group).
Eligible subjects in the trial will be randomized to either the control group or the intervention group. The control group will receive the standard of care (SOC) analgesia as determined by their treating physician and departmental guidelines. The intervention group will receive VR therapy via a headset as an adjunct to the SOC therapies prescribed. Study investigators will record pain scores, vital signs, and adverse effects at 0, 15, 30, 60, 90, and 120 minutes. In addition, anxiety and stress will be assessed before and after utilization of VR in the intervention group at 0, 30, 60 and 120 minutes. Subjects enrolled in the control group will have an evaluation of anxiety and stress recorded at 0, 30, 60, and 120 minutes as a part of secondary outcome measures as well.
- Conditions
- Acute Musculoskeletal Pain
- Being tested
- Standard of Care Analgesia, Standard of Care Analgesia + Virtual Reality
- Keywords
- Geriatric, Emergency Medicine, Virtual Reality, Acute Pain
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care AnalgesiaOther
Analgesia as determined by the treating physician
Standard of Care Analgesia + Virtual RealityOther
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
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Analgesia as determined by the treating physician Receives: Other: Standard of Care Analgesia |
| Virtual Reality (VR) + Standard of Care (SOC) | Active comparator | 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 Receives: Other: Standard of Care Analgesia + Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction
A reduction of pain scores on the Numeric Rating Scale (0: no pain; 5 moderate pain; 10 extreme pain)
Measured: 60 minutes
Secondary outcomes (3)
Anxiety
Anxiety will be measured by the Spielberger State-Trait Anxiety Inventory (STAI-S) scale which range is between 20 and 80, with scores >40 indicative of appreciable anxiety.
Measured: 60 minutes
Acute Stress
Acute Stress will be measured by 11-point stress Numerical Rating Scale (SNRS-11) (0 no stress; 5 moderate stress, 10: extreme stress) and at a self-reported nominal level
Measured: 60 minutes
Adverse Effects
Adverse Effects occurring such as headache, dizziness, nausea, motion sickness
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start18 Nov 2024
- Primary completion30 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antonios Likourezos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonios Likourezos, Maimonides Medical Center
- Investigators
- Sergey Motov, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685107
- Sponsor's protocol ID
- 2023-09-05
- Status last verified
- Oct 2026
- First submitted
- 11 Nov 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided