Pain Rehabilitation Virtual Reality (PRVR): Innovations to Enhance Mobility in the Presence of Pain (PRVR)

The proposed research is a single arm feasibility trial of pain rehabilitation virtual reality (PRVR) aimed at measuring feasibility, acceptability and utility of VR as well as changes in physical function and fear for adolescents with chronic musculoskeletal pain. The intervention includes standard physiotherapy treatment including functional goal setting and progressive exercise.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Chronic Pain; Fibromyalgia; Virtual Reality
• Intervention / Treatment: Behavioral: Standard Physiotherapy Rehabilitation (SPR); Behavioral: Pain Rehabilitation Virtual Reality (PRVR)

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Menlo Park, California, United States, 94025
      • Pediatric Pain Management Clinic - Stanford Children's Health
    • Palo Alto, California, United States, 94306
      • California Rehabilitation and Sports Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 10 to 17 years old
• Musculoskeletal pain (e.g. localized [back, limb], diffuse) not due to acute trauma (e.g. active sprain or fracture)
• English Language Proficiency

Exclusion Criteria:

• Significant cognitive impairment (e.g., brain injury)
• Significant medical or psychiatric problem that would interfere (e.g. psychosis, suicidality)
• Presents with a condition that interferes with virtual reality usage (e.g., history of seizure, facial injury precluding safe placement of headset, visual impairment, significant hearing impairment impact ability to follow audio instructions).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Physiotherapy Rehabilitation (SPR); Sessions are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 consisting of 1) therapeutic exercise, 2) balance and proprioception, 3) strength training, and 4) use of modalities (e.g., heat/cold pack). Patients will be given a structured Home Exercise Program (HEP) with prescribed exercises for home. SPR participants will be allocated a VR headset for recreational use.	Behavioral: Standard Physiotherapy Rehabilitation (SPR); Participants allocated to either intervention arm will receive 8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks. Adequate dose: 75% (6 of 8 sessions).
Experimental: Pain Rehabilitation Virtual Reality (PRVR); Participants will complete VR in PT to engage participants in a series of immersive games customized to align with individual PT needs delivered over ~6-12 weeks or until clinician believes the patient is done with treatment. Patients in the PRVR arm will be given a structured HEP to practice prescribed exercises at home with integrated VR activities. PRVR participants will be allocated a VR headset for use in PT sessions and with HEP. VR will supplement treatment and be used in session (either in-person or telehealth) and at home as part of their prescribed treatment homework.	Behavioral: Pain Rehabilitation Virtual Reality (PRVR); Participants will receive approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks. Adequate dose: 75% (6 of 8 sessions).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VR Duration of Use Per Week	This outcome is to assess Feasibility, Acceptability, and Utility of VR.	Baseline to end of treatment across 6-8 weeks, on average
Participant Rated Ease of Use	This outcome is to assess Feasibility, Acceptability, and Utility of VR.	End of treatment at 6-8 weeks, on average
Participant Rated Enjoyment	This outcome is to assess Feasibility, Acceptability, and Utility of VR.	End of treatment at 6-8 weeks, on average

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain-related Fear and Avoidance	Fear of Pain Questionnaire Short Form (FOPQ- SF): a 10-item validated patient-reported measure of pain-related fear and avoidance. Total score range: Min=0, Max=40; lower score indicates less fear and avoidance/better outcomes.	Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment
Physical Function: Lower Extremity	Lower Extremity Functional Scale (LEFS): a 20-item validated patient-reported measure of lower extremity function. Overall score range: Min=0, Max=80; lower score indicates greater disability/worse outcomes.	Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment
Physical Function: Upper Extremity	Upper Extremity Functional Index (UEFI): a 20- item validated patient-reported measures of upper extremity functioning. Overall score range: 0 to 80, with greater scores indicating increased upper extremity functioning.	Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Laura Simons, PhD, Stanford School of Medicine

Publications and helpful links

General Publications

• Simons LE, Hess CW, Choate ES, Van Orden AR, Tremblay-McGaw AG, Menendez M, Boothroyd DB, Parvathinathan G, Griffin A, Caruso TJ, Stinson J, Weisman A, Liu T, Koeppen K. Virtual Reality-Augmented Physiotherapy for Chronic Pain in Youth: Protocol for a Randomized Controlled Trial Enhanced With a Single-Case Experimental Design. JMIR Res Protoc. 2022 Dec 12;11(12):e40705. doi: 10.2196/40705.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): December 7, 2024
• Study Completion (Actual): December 7, 2024

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Musculoskeletal Pain; Fibromyalgia; Chronic Pain
• Other Study ID Numbers: 68669; R21AR079140 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (text, tables, figures, appendices) that underlie the results reported in an article related to this trial will, after de-identification, be shared with researchers who provide a methodologically sound proposal.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Proposals should be directed to Dr. Laura Simons at lesimons@stanford.edu. To gain access, data requestors will need to sign a data access agreement with Stanford University.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No