Virtual Reality for Chronic Pain Management

Overseen By Cynthia Nguyen, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Must not be taking: Sedating medications

Disqualifiers: Seizure disorder, Untreated psychiatric illness, others

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

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jennifer Stinson, RN, PhD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

This trial is for teens aged 12-18 with chronic pain, who can speak and read English, are under care at a specific clinic, have stable medication/therapy, can move safely on their own, need at least 4 virtual physiotherapy sessions, and have internet access. It's not for those with seizure risks, major untreated mental illnesses or personality disorders, VR intolerance (like nausea), recent headaches/migraines or concussions.

Inclusion Criteria

I have been diagnosed with chronic pain.

My medication for pain has not changed in the last week.

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

I have new or worsening headaches, motion sickness, nausea, vomiting, or possible concussion symptoms.

You have a serious untreated mental illness, like depression, anxiety, or PTSD.

You feel very uncomfortable in small spaces or have had a bad experience with virtual reality in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in either a custom VR program or an off-the-shelf VR program combined with standard virtual physiotherapy treatment, or just the standard virtual physiotherapy treatment, over 4 weeks.

4 weeks

1 session per week, total 4 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain intensity, physical functioning, and other outcomes.

1 year

Treatment Details

Interventions

• Custom VR
• Off the Shelf VR

Trial Overview The study tests if virtual reality programs designed for pain rehabilitation are user-friendly and effective in improving pain management and physical function in teens during COVID-19 compared to standard videoconference physiotherapy. Teens' experiences will be evaluated through questionnaires and interviews.

Participant Groups

Group I: Off the Shelf VR (PR-VR program + usual care) Experimental Treatment 1 Intervention

* One session per week x 4 weeks; total 4 sessions over 1 month * PR-VR program (30 min) + Usual care (30 min SVPT) * Total intervention time = 4 hours * 10 selected for post-study telephone interview

Group II: Custom VR (Modified PR-VR program + usual care) Experimental Treatment 1 Intervention

* One session per week x 4 weeks; total 4 sessions over 1 month * Mod PR-VR program (30 min) + Usual care (30 min SVPT) * Total intervention time = 4 hours * 10 selected for post-study telephone interview

Group III: Standard Virtual Physiotherapy Treatment (control; usual care), Active Control 1 Intervention

* One session per week x 4 weeks; total 4 sessions over 1 month * Usual care (60 min SVPT) * Total intervention time = 4 hours

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+