The Feasibility of Immersive Virtual Reality as a Treatment for Chronic Back Pain
Phase: NA
Conditions: Chronic Back Pain
Sponsor: Tufts University

 
 
 
 
 
 
PI: Nancy Baker 
 
Funding: 2020 Tufts CTSI Pilot Studies Program  
Through Tufts CTSI NIH Clinical and Translational Science Award 
(UL1TR002544) 
 
 
 
Tufts Health Sciences IRB # 00000192 
 
 
 
 
 
 
 
August 1, 2023 
 
 
The Feasibility of Immersive Virtual Reality as a 
treatment for Chronic Back Pain 

Manual of Operating Procedure: Implementing Virtual Reality into the treatment of chronic pain: An efficacy study 
PI: Nancy Baker 
 
 
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Manual of Operating Procedure: Implementing Virtual Reality into the treatment of chronic pain: An efficacy study 
PI: Nancy Baker 
 
 
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Overview of Study 
In the proposed project we will evaluate the feasibility of IVR and assess the initial 
effects of IVR on symptoms, affect, and tolerance to cutaneous stimuli. In this single-
arm trial, we will recruit 20 adults with CBP. Prior to their IVR experience, subjects will 
complete multiday baseline assessments using ecological momentary assessment 
(EMA) methodology to establish typical levels of symptoms and affect.  They will return 
for two counterbalanced IVR sessions: one 10-minute and one 20-minute. Immediately 
after each session we will measure current symptoms and affect using valid and reliable 
self-report questionnaires, and we will measure changes in tolerance to cutaneous 
stimuli using quantitative sensory testing. We will measure symptoms and affect for 72 
hours after each experimental session using EMA to determine if there is a carryover. At 
the completion of this study, we will continue to work with stakeholders to develop 
clinically relevant IVR interventions for people with CBP. Our study will have two aims:  
Aim 1: Determine the feasibility and clinical usability of using IVR as an intervention for 
people with CBP. 
Aim 2a: Examine the magnitude of the effects of IVR on symptoms, affect, and 
tolerance to cutaneous stimuli. 
2b: Examine the effect of dosage (10 min, 20 min) on symptoms, affect, and 
tolerance to cutaneous stimuli. 
 

Manual of Operating Procedure: Implementing Virtual Reality into the treatment of chronic pain: An efficacy study 
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Grant Flow Chart 
 
 
 

Manual of Operating Procedure: Implementing Virtual Reality into the treatment of chronic pain: An efficacy study 
PI: Nancy Baker 
 
 
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Study Design: This is a cross-over feasibility trial. 
Subjects: We will recruit 20 people with chronic back pain.   
Inclusion/Exclusion criteria: Inclusion criteria: 30 to 65 years old; Low Back Pain that has lasted 
greater than 3 months due to non-cancer related injury or illness. Exclusion criteria: People with 
back pain due to rheumatic (e.g. rheumatoid arthritis or fibromyalgia) or central neurological 
disorders (e.g. stroke, multiple sclerosis, spinal cord injury); vision to see IVR programs; 
insufficient upper extremity coordination to operate IVR controls; insufficient cognitive ability to 
answer questionnaires or learn to use the IVR; unable to understand and respond to English.  
Subjects must have access to a cell phone or tablet for baseline and follow-up EMA testing. 
There are no exclusion criteria based on sex, race, ethnicity, or sexual orientation. 
Recruitment: Throughout the grant we will work with Tufts CTSI Recruitment and Retention 
Support Unit (RSSU) to devise customized, multi-modality strategies to minimize accrual time 
and maximize participant retention in research studies. Strategies include: 1) We will access the 
Brigham & Women’s Chronic Pain Registry and mail letters to appropriate candidates. 2) We 
will query the Tufts Medical Center's Clinical Academic Research Enterprise Trust (CLARET) 
data warehouse to identify eligible patient population.  The CLARET is a centralized clinical data 
warehouse that aggregates clinical information from various Tufts Medical Center's systems. 3) 
The Tufts Medical Center website publicly posts general information about all research studies 
so that people can identify and contact studies. 4) We will deploy targeted advertising using 
Facebook Ads; 5) We will place fliers/advertisement placed in the following CBP program 
waiting areas: Brigham & Women’s, Tufts Chronic pain, Medford Chronic pain.   
Outcome measures 
Our study will include feasibility measures and magnitude of effect measures: Feasibility 
measures will examine the practicalities of investigating implementation of IVR for people with 
CBP and subjects’ preferences and tolerance to the protocol. 
Item 
Measurements 
Recruitment 
Responses to different recruitment methods; # contacting study; # 
coming to study; # consented; Recruitment generating appropriate 
subjects; # willing to be randomized 
Adherence/Fidelity Immersion into VR (Igroup Presence Questionnaire [IPQ]); 
Engagement in IVR (User Engagement Scale [UES]); # of breaks; # 
of subjects completing study; Completeness of data collection 
Burden 
Length of time to complete measures, length of time for ecological 
momentary assessment (EMA) responses, subjects’ perception of 
burden (open-ended questions) 
Tolerance 
Tolerance to IVR (Simulator Sickness Questionnaire [SSQ]); minutes 
in IVR experience; tolerance to Quantitative Sensory Testing (QST); 
open-ended question responses 
Stakeholder input 
Open ended questions about perceptions and preferences. 
Measures for the magnitude of effect will address symptoms, affect and tolerance to cutaneous 
stimuli.  All the proposed measures are valid and reliable measures of the proposed construct.   
Item 
Measurements 
Symptoms 
Pain Pain Visual Analogue Scales (VAS) (EMA and Session), PROMIS pain 
interference scale (Session)  
Fatigue PROMIS Daily Fatigue Scale (EMA and Session), PROMIS Fatigue Scale 

Manual of Operating Procedure: Implementing Virtual Reality into the treatment of chronic pain: An efficacy study 
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(Session) 
Affect 
Positive and Negative Affect Scale (PANAS) (EMA and Session)  
Quantitative Sensory Testing (QST) (Session) 
Hyperalgesia Mechanical Pressure Pain Thresholds (MPPTh) will be assessed using a digital 
pressure algometer on the right upper trapezius and right thumb MP joint. 
 Mechanical Temporal Summation of Pain (MTSP) will be assessed using 
weighted pinprick stimulators. We will apply a train of 10 stimuli at the rate of 1 
per second on the middle finger of the right hand, and subjects will rate the 
painfulness of the first, fifth, and tenth stimulus.  
Intervention Immersive Virtual Reality (IVR) 
Our IVR experiences will be delivered with the Oculus RiftS system (headset and hand 
controllers) using commercially available VR software.  IVR sessions will last either 10 or 20 
minutes. Subjects will select an IVR experience that appeals to them.  
Protocol 
Visit 1 (remote): We will obtain informed consent.  Subjects will complete surveys on 
demographics and symptoms (pain, fatigue) and affect.  Subjects will be randomly assigned to 
receive the 10 min or 20 min IVR session first. 
We will also upload the EMA technology onto the subject’s phone or tablet. Visit 1 will take up to 
~1 hour. 
Multiple Baseline EMA: Visit 2 will be scheduled 1-2 weeks later. During the time between visits 
we will use ecological momentary assessment (EMA) technology to collect multiple measures of 
pain, fatigue and affect. In EMA subjects respond to prompts delivered through their cell phone 
or tablet (“pings”) with documentation of current symptoms.  It is a well-recognized method to 
capture immediate, synchronized experiences in subjects’ natural environments.  During this 
data collection period subjects will be “pinged” 3x daily and asked to rate their current levels of 
pain, fatigue, and affect.  Time to complete these responses will be less than 5 minutes. 
Visit 2: We will collect current pain, pain interference, fatigue and affect, and QST.  Subjects will 
receive an IVR session lasting either 10 or 20-min depending upon randomization. They will rate 
their current pain, fatigue, and affect, and we will complete QST.  At the end of both sessions 
the subjects will rate their experiences of immersion using the Igroup Presence Questionnaire, 
engagement using the Use Engagement Scale (UES), and simulation tolerance using the 
Simulator Sickness Questionnaire (SSQ). Visit 2 will take about ~1 hour. 
Post Visit 2 EMA:  Subjects will complete three more days of 3x a day prompts for pain, fatigue 
and affect. 
After Visit 2 we will follow-up with subjects using EMA for at least 72 hours to determine if there 
is any carryover of effect of IVR.  This period will also act as a washout period before returning 
for the third visit. 
Visit 3 will be the same as Visit 2. Participants will complete 10- or 20- minutes of VR depending 
upon randomization.  We will complete a short semi-structured interview. 
 
Analysis  
Aim 1 - Feasibility: We will identify the number of people from each referral source who 
contacted study personnel, volunteered to participate, and signed the consent. We will assess 
adherence to study protocols, including percentages completing outcome measures (including 
EMA) and completing both visits. We will assess IVR tolerance using the Simulator Sickness 
Questionnaire, pain threshold testing tolerance through direct questions, and the degree to 
which subjects felt engaged in the experience using the Igroup Presence Questionnaire.  We 

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will determine how long it takes to complete the various parts of the study and how many breaks 
or incompletes occur during the intervention protocol. We will also examine expectations and 
perceptions of the IVR experience using open-ended questions.   
 
Aim 2 - Effect:  We will calculate effect sizes to compare baseline data to scores obtained 
immediately after completing IVR sessions. Symptoms and affect: We will examine the 
immediate effect of the IVR sessions by comparing the baseline symptom data with scores 
taken after completing the session.  Tolerance to cutaneous sensory input: We will assess 
baseline and pre-session pain threshold levels with immediate post session measurements.  
To examine differences related to dosage, we will calculate an effect size between those who 
received the 10-minute IVR and those who received the 20-minute IVR session.