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

Chronic Pain Clinical Trial

— PRVR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04636177
• Other study ID #: 59300
• Secondary ID: R21AR079140
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: November 30, 2025

Study information

• Verified date: September 2023
• Source: Stanford University
• Contact: Nicole Jehl, BS
• Phone: (650) 725-8111
• Email: njehl[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Musculoskeletal Pain
• Virtual Reality

Intervention

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).

Locations

Country	Name	City	State
United States	Pediatric Pain Management Clinic - Stanford Children's Health	Menlo Park	California
United States	California Rehabilitation and Sports Therapy	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility, Acceptability, and Utility of VR	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.	Baseline to end of treatment at 6-8 weeks, on average
Secondary	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. (score Min=0, Max=40; lower score indicates less fear and avoidance/better outcomes).	Baseline to end of treatment at 6-8 weeks, on average
Secondary	Physical Function: Lower Extremity	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).	Baseline to end of treatment at 6-8 weeks, on average
Secondary	Physical Function: Upper Extremity	Upper Extremity Functional Index (UEFI): a 20- item validated patient-reported measures of	Baseline to end of treatment at 6-8 weeks, on average