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

Not Applicable

Active, not recruiting

• Conditions: Musculoskeletal Pain; Fibromyalgia; Chronic Pain; Virtual Reality
• Interventions: Behavioral: Pain Rehabilitation Virtual Reality (PRVR)

• 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
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-03-31
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• 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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pain Rehabilitation Virtual Reality (PRVR)	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.

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
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
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).

Trial Locations

Locations (2)

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

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