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

Stanford University34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Pain Musculoskeletal Pain Fibromyalgia Virtual Reality

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).

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).

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

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).

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

Outcomes

Primary Outcomes

VR Duration of Use Per Week

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

Time frame: 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.

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

Participant Rated Enjoyment

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

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

Secondary Outcomes

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. Total score range: Min=0, Max=40; lower score indicates less fear and avoidance/better outcomes.

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

Physical Function: Lower Extremity

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.

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

Physical Function: Upper Extremity

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.

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

Data from ClinicalTrials.gov

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