Clinical trial NCT04912817: PR-VR At-home Program During and After COVID-19
Official title: Pain Rehabilitation Virtual Reality (PR-VR) At-home Program: A Pilot Randomized Controlled Trial to Determine Feasibility and Impact on Pain and Function in Adolescents During and After COVID-19
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Chronic
Keywords: paediatric chronic pain
virtual reality
COVID-19
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2021-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot RCT (1:1:1 group allocation) will be used to examine the feasibility of the trial protocol for a definitive trial into the effectiveness of Off-the-shelf VR, Custom VR (Fruity Feet) and Standard Virtual PT (SVPT) in adolescents with chronic pain undergoing functional rehabilitation at home.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Poorly controlled chronic pain in teens can impact quality of life, increase opioid use and is a risk factor for developing chronic pain in adulthood. Currently, there is a shortage of support to help teens manage chronic pain in the community and the support that did exist has been significantly scaled back due to the COVID-19 pandemic. This research study will investigate, based on questionnaires with teens and healthcare providers and interviews with teens, whether pain rehabilitation virtual reality is easy to use and understand, satisfactory to use, and whether it may improve pain, mobility, and function for the teens using the program compared to those doing standard physiotherapy treatment over videoconference.

Detailed description: Chronic pain affects the lives of 1 in 5 - or 2 million - Canadian children and adolescents and has negative impacts on all aspects of health-related quality of life as well as significant economic costs to families and society. The standard of care for pediatric chronic pain management is an interprofessional biopsychosocial treatment approach, a cornerstone of which is physiotherapy (PT) led functional rehabilitation. Furthermore, lack of access to pain clinics and physiotherapy is an ongoing issue which has been exacerbated by the current COVID-19 pandemic; many ambulatory pediatric chronic pain clinics and community-based physiotherapists have halted appointments, with only a few pivoting to virtual service delivery. Providing care virtually is particularly challenging in this field given the physical and hands-on nature pain physical therapy assessment and treatment. These challenges delay treatment and leave vulnerable youth at risk for severe sequelae without the services they require for recovery.

Virtual reality (VR) can help bridge these gaps in care during and beyond COVID-19 by reducing fear associated with movement. A growing body of research has shown the power of immersive VR for reducing anxiety and managing acute pain via distraction in children and adolescents. While there is emerging evidence for the benefit of VR for treating chronic pain in adults, there is minimal research evaluating VR's effectiveness for reducing pain and improving physical function in children and adolescents with chronic pain. Changes to health service delivery due to the COVID- 19 pandemic confirms the crucial need to develop a comprehensive, engaging, and effective approach to home-based chronic pain rehabilitation. The ability of VR to offer patients with chronic pain access to multi-sensory, 3D, immersive therapeutic experiences, has the potential to break the cycle of pain, fear and activity avoidance from a patient's own home.

This pilot randomized controlled trial (RCT) will: (1) Primary Aim: determine the feasibility of implementing an off-the-shelf VR program and custom VR program (i.e., accrual rates, engagement in therapy sessions, retention rates, technical and practical issues, time to set up and conduct PR-VR, treatment acceptability, outcome evaluation, adverse events and participant satisfaction) and; (2) Secondary Aim: evaluate preliminary effectiveness (estimates of magnitude of effect) of VR interventions compared to the usual care condition (standard virtual PT \[SVPT\]).

Eligibility criteria: Inclusion Criteria:

1. able to speak and read English,
2. 12-18 years old,
3. diagnosed with chronic pain,
4. under active care at the interprofessional out-patient Chronic Pain Clinic at SickKids,
5. on stabilized medication/therapy (no new pain medications/therapies for 1 week prior to the initial PT assessment and treatment) according to medical chart,
6. independently mobile and able to safely engage in physical activity,
7. requiring a minimum of 4 treatments (1-hour sessions of virtual PT) typically once per week,
8. able to have access to an Internet-enabled smartphone, computer or tablet at home (typically once per week for 4 weeks) according to self-report for Zoom for Healthcare visits with PT, and
9. willing to have Zoom for Healthcare visits with PT recorded during the study period and, if selected, individual telephone interview with research assistant (RA) audio recorded following the study period.

Exclusion Criteria:

1. visual, auditory or cognitive impairments precluding interaction with the PR-VR intervention and/or control equipment (Internet) as assessed by reviewing the patient's medical chart and consultation with the patient's PT.
2. diagnosis of seizure disorder, history of seizure, or increased risk of seizure.
3. new onset of headaches/migraines, motion sickness, nausea or vomiting or history/symptoms of possible concussion.
4. diagnosis of major, untreated, concurrent psychiatric illness (e.g., depression, anxiety, conversion disorder, PTSD) or personality disorder as assessed by reviewing the patient's medical chart and in consultation by their health care team.
5. currently receiving sedating medications
6. claustrophobia or previous intolerance of virtual reality (e.g. nausea, vomiting, motion sickness, eye strain, false memory formation) as assessed by health care team.

Primary outcomes:
measure: Participant Accrual
timeFrame: 1 year
measure: Participant Engagement
timeFrame: 1 year
measure: Participant Retention
timeFrame: 1 year
measure: Technical Issues
timeFrame: 1 year
measure: Safety of PR-VR Program
timeFrame: 1 year
measure: Time
timeFrame: 1 year
measure: Acceptability/Satisfaction
timeFrame: 1 year
measure: Outcome measure feasibility
timeFrame: 1 year
Secondary outcomes:
measure: Fear of movement
timeFrame: Collected at baseline (T1) and 4 weeks from baseline (T2)
measure: Pain self-efficacy
timeFrame: Collected at baseline (T1) and 4 weeks from baseline (T2)
measure: Pain catastrophizing
timeFrame: Collected at baseline (T1) and 4 weeks from baseline (T2)
measure: Pain intensity
timeFrame: Collected at baseline (T1), and immediately post- each PT session verbally to the PT, and 4 weeks from baseline (T2)
measure: Presence/immersiveness
timeFrame: Post- each PT session, through study completion, an average of 1 year
measure: Exercise intensity
timeFrame: reported verbally to PT Pre-, during (10 minutes from the start of their session), and post- each PT session - through study completion, an average of 1 year
measure: Physical activity levels
timeFrame: 6 months
measure: Physical functioning - Mobility
timeFrame: Collected at baseline (T1) and 4 weeks from baseline (T2)
measure: Physical functioning - lower extremity
timeFrame: Collected at baseline (T1) and 4 weeks from baseline (T2)
measure: Physical functioning - upper extremity
timeFrame: Collected at baseline (T1) and 4 weeks from baseline (T2)
measure: Physical functioning - functional disability
timeFrame: Collected at baseline (T1) and 4 weeks from baseline (T2)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Jennifer Stinson, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: