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

NCT04636177 | Completed Results DMC

• 2 other identifiers: 68669R21AR079140
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Pain; Musculoskeletal Pain; Fibromyalgia; Virtual Reality

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Pain-related Fear and Avoidance

  Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment

• Physical Function: Lower Extremity

  Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment

• Physical Function: Upper Extremity

  Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment

Study Arms (2)

Pain Rehabilitation Virtual Reality (PRVR)

EXPERIMENTAL

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)

Standard Physiotherapy Rehabilitation (SPR)

ACTIVE COMPARATOR

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)

Interventions

Pain Rehabilitation Virtual Reality (PRVR) BEHAVIORAL

Participants will receive approximately 8, 1-hour physiotherapy sessions delivered over the course of 6-12 weeks. Adequate dose: 75% (6 of 8 sessions).

Pain Rehabilitation Virtual Reality (PRVR)

Standard Physiotherapy Rehabilitation (SPR) BEHAVIORAL

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).

Standard Physiotherapy Rehabilitation (SPR)

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

Pediatric Pain Management Clinic - Stanford Children's Health

Menlo Park, California, 94025, United States

Location

California Rehabilitation and Sports Therapy

Palo Alto, California, 94306, United States

Location

Related Publications (1)

• 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.

  PMID: 36508251 DERIVED

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain; Fibromyalgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Laura E Simons
• Organization: Stanford University School of Medicine

lesimons@stanford.edu

(650) 736-0838

Study Officials

• Laura Simons, PhD

  Stanford School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: March 10, 2022
• Primary Completion: December 7, 2024
• Study Completion: December 7, 2024
• Last Updated: November 14, 2025
• Results First Posted: November 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• 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.

Locations

US (2)