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

Not Applicable

Completed

• Conditions: Musculoskeletal Pain; Fibromyalgia; Chronic Pain; Virtual Reality

• Registration Number: NCT04636177
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-19
• Study Start: 2022-03-10
• Primary Completion: 2024-12-07
• Study Completion: 2024-12-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility, Acceptability, and Utility of VR	Baseline to end of treatment at 6-8 weeks, on average	Acceptability will be assessed via collected use metrics (e.g. how long the app was played each day) and will also qualitatively at the end of treatment through interview questions related to acceptability, ease of use, comprehensibility, and suggestions for improvement. Qualitative responses will be described and summarized.

Secondary Outcome Measures

Name	Time	Method
Pain-related Fear and Avoidance	Baseline to end of treatment at 6-8 weeks, on average	Fear of Pain Questionnaire Short Form (FOPQ- SF): a 10-item validated patient-reported measure of pain-related fear and avoidance. (score Min=0, Max=40; lower score indicates less fear and avoidance/better outcomes).
Physical Function: Lower Extremity	Baseline to end of treatment at 6-8 weeks, on average	Lower Extremity Functional Scale (LEFS): a 20-item validated patient-reported measure of lower extremity function. (score Min=0, Max=80; lower score indicates greater disability/worse outcomes).
Physical Function: Upper Extremity	Baseline to end of treatment at 6-8 weeks, on average	Upper Extremity Functional Index (UEFI): a 20- item validated patient-reported measures of

Trial Locations

Locations (2)

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

California Rehabilitation and Sports Therapy; 🇺🇸 Palo Alto, California, United States