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Completed

NCT Number: NCT04636177

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

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.

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Key information

Conditions

Chronic Pain Fibromyalgia Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Virtual Reality

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Pain Management Clinic - Stanford Children's Health, Menlo Park, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

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).

Primary outcomes

  1. VR Duration of Use Per Week

    Time frame: Baseline to end of treatment across 6-8 weeks, on average

    This outcome is to assess Feasibility, Acceptability, and Utility of VR.

  2. Participant Rated Ease of Use

    Time frame: End of treatment at 6-8 weeks, on average

    This outcome is to assess Feasibility, Acceptability, and Utility of VR.

  3. Participant Rated Enjoyment

    Time frame: End of treatment at 6-8 weeks, on average

    This outcome is to assess Feasibility, Acceptability, and Utility of VR.

Secondary outcomes

  1. Pain-related Fear and Avoidance

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

    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.

  2. Physical Function: Lower Extremity

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

    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.

  3. Physical Function: Upper Extremity

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

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Acronym: PRVR

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 19, 2020
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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