VANISH (Virtual Autonomic Neuromodulation Induced Systemic Healing) for Chronic Low Back Pain (CLBP)
Phase: NA
Conditions: Chronic Low-back Pain
Sponsor: Ajay Wasan, MD, Msc

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Study Protocol  
 
 
 
 
 
 
Official Title: 
The Effects of Virtual Reality with Debriefing on Patients with 
Chronic Pain 
 
 
ClinicalTrials.gov ID (NCT number): 
NCT04236804 
 
 
Protocol Date: 
2024-12-20 
 
 
 

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Scientific Background 
Chronic musculoskeletal pain, defined as persistent or recurrent pain lasting more than three 
months, is a disabling condition with significant physiological and psychosocial implications. 
Unlike acute pain, chronic pain serves no adaptive purpose, as it often persists after the original 
precipitating event (e.g., fracture, sprain, trauma) has resolved. 
Immersive Virtual Reality (IVR) has shown potential as a treatment for acute pain, but its use for 
chronic pain remains underexplored. IVR enables individuals to immerse themselves in a three-
dimensional environment, promoting normal movement patterns by distracting them from their 
pain. This study examines the effects of IVR combined with occupational therapy (OT) to 
determine whether it reduces chronic pain and associated symptoms more effectively than OT 
alone. 
 
Study Objectives 
• Primary Objective: To evaluate changes in Morphine Milligram Equivalent (MME) use 
from baseline to three months in patients receiving OT with or without IVR. 
• Secondary Objectives: 
• 
To assess changes in chronic pain intensity using the Numeric Pain Rating Scale. 
• 
To evaluate self-efficacy, fear of movement, and functional participation using 
validated scales, including the Pain Self-Efficacy Questionnaire, the Tampa Scale of 
Kinesiophobia, and the Goal Attainment Scale. 
• 
To assess changes in patient-reported outcomes such as sleep disturbance, physical 
function, and emotional well-being using PROMIS measures. 
 
Study Design & Methods 
• Study Type: Interventional 
• Allocation: Randomized 
• Interventional Model: Parallel Assignment 
• Masking: None (Open Label) 
• Primary Purpose: Treatment 
 
Arms and Interventions: 
1. Active Comparator: Occupational Therapy (OT) 
o Participants receive six 1-hour outpatient OT sessions tailored to chronic pain 
management, including education, exercises, stress management, and daily 
activity planning. 
2. Experimental: Occupational Therapy + Virtual Reality (OT+VR) 
o Participants receive a combination of OT and 10–30 minutes of IVR during each 
session. IVR sessions include interactive exercises and games, followed by 
therapist-led debriefing. 
Measurements: 
• 
Participants complete surveys before and after each therapy session. 
• 
Additional bi-weekly online surveys are administered for the study duration. 
 
Eligibility Criteria  

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Inclusion Criteria: 
• 
Adults aged 18 years or older. 
• 
Referred for chronic pain OT at UPMC Centers for Rehab Services. 
Exclusion Criteria: 
• 
History of seizure disorders or recent VR intervention. 
• 
Sensory insensitivity or contagious facial disorders incompatible with VR headset use. 
• 
Insufficient cognitive ability or physical coordination for IVR use. 
 
Statistical Considerations 
This study was designed to evaluate the effects of occupational therapy with or without 
immersive virtual reality on MME and patient-reported outcomes over an 8-week period. 
Following consultation with study clinicians, the primary outcome was revised to focus on 
patient-reported changes in MME from baseline to 8 weeks, ensuring alignment with the study's 
therapeutic goals. 
Primary Analysis: 
• 
Within-group changes in MME and PROMIS measures from baseline to 8 weeks will be 
analyzed using paired t-tests or Wilcoxon signed-rank tests (for non-normally distributed 
data). 
• 
Between-group differences will be assessed using independent t-tests or Mann-Whitney 
U tests. 
Secondary Analysis: 
• 
Changes in PROMIS measures (e.g., pain intensity, fatigue, and depression) will be 
analyzed using similar methods. Adjustments will be made for baseline values in 
secondary outcomes using linear regression. 
Handling Missing Data: 
• 
Missing data will be addressed using multiple imputation under the assumption that data 
are missing at random. Sensitivity analyses will compare results from imputed datasets 
with complete-case analyses. 
Adjustment for Covariates: 
• 
Analyses will adjust for baseline MME, PROMIS scores, and demographic factors (age, 
gender) where appropriate. 
Challenges Due to Small Sample Size: 
• 
The study's small sample size (n=20) limits statistical power, increasing the risk of Type 
II error and reducing the ability to detect small-to-moderate effect sizes. This limitation 
may affect the robustness of statistical inferences. Findings should be interpreted with 
caution and viewed as exploratory in nature. 
Software: 
• 
All statistical analyses will be performed using R (version 4.3.1). Detailed analysis 
scripts will be maintained to ensure reproducibility. 
Subgroup and Sensitivity Analyses: 
• 
Subgroup analyses will examine treatment adherence and baseline PROMIS scores. 
Sensitivity analyses will explore the impact of different imputation methods for missing 
data.