Use of Virtual Reality for Musculoskeletal Pain
Phase: NA
Conditions: Fibromyalgia
Sponsor: Tufts University

 
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Protocol Summary 
 
PRINCIPAL/OVERALL INVESTIGATOR: Dr. Robert Edwards, Ph.D. 
Co-Investigators: Aliza Spielman OTD/s.  
PROTOCOL TITLE 
The Feasibility & Effectiveness of Virtual Reality in Reducing Pain for Older Adults with Knee 
Osteoarthritis  
FUNDING 
• None 
VERSION DATE 
06 April, 2022 
SPECIFIC AIMS 
1. The purpose of this project is to evaluate the feasibility and effectiveness of VR as a 
treatment option for older adults with chronic osteoarthritic knee pain. 
2. Aim 1: Implement a pilot study and collect data on the feasibility of VR and its effects on 
pain for older adults with chronic osteoarthritic knee pain. 
3. Aim 2: Analyze the feasibility of VR for this population, including looking at simulation 
sickness factors and drop out reasons/rates, and its impact on chronic pain immediately 
prior to and immediately post intervention, as well as a few days post intervention. 
4. Sub-study Aim 1: The aim of this sub-study is to compare the effectiveness of a virtual 
reality meditation session and a non-immersive meditation session for improving pain, 
affect, and physiological vital stats in adults with fibromyalgia. 
5. Sub-study Aim 2: We hypothesize that the VR meditation session will facilitate greater 
improvements in pain, affect, and physiological vital stats as compared to the non-
immersive meditation intervention. 
 
BACKGROUND AND SIGNIFICANCE 
Thirty percent of older adults in the United States report experiencing chronic pain, with 
41% of this subset of the population experiencing chronic joint pain (NIH Pain 
Consortium, n.d.). Knee osteoarthritis (OA) affects 37% of individuals aged 60 years or 
older who participated in the National Health and Nutrition Examination (Sharma, 2021). 
This condition typically involves pain, stiffness, reduced joint motion and muscle 
weakness, and chronic pain that can have profound effects on physical function, 
psychological parameters, and overall quality of life. Past studies at the PMC have looked 
at the physiological mechanisms involved with chronic knee OA and the older adult 
population, the site has had limited funding to research nonpharmacological treatments 
such as virtual reality. Virtual reality has been shown to be feasible for a variety of 
populations, including young people with autism experiencing specific phobia, pediatric 

 
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burn patients, and young adults (Maskey et al., 2019; Hoffman et al., 2014, Sakhare et al., 
2019). However, there is limited evidence on the feasibility of VR for treating pain for 
the older adult population. This study aims to study they effectiveness of VR for chronic 
pain for older adults and is necessary to determine best methods to feasibly integrate VR 
into clinical practice. 
Sub-study: 
Fibromyalgia (FM) is a debilitating rheumatological syndrome which affects millions of 
adults in the United States. The condition presents with widespread chronic muscular 
pain and reduced pain thresholds (CDC, 2020). Additional symptoms that often 
accompany FM include fatigue, insomnia, and negative affect. As with knee OA, the 
chronic pain that is caused by FM can have significant effects on physical function, 
psychological parameters, and overall quality of life. Just as VR distraction may be a 
useful tool for clients experiencing chronic knee OA, the same principles apply for pain 
management for those with FM. Previous research has demonstrated that affect was 
improved for clients with FM who participated in a 10-minute VR mindfulness session 
(Botella, et al, 2013). Such findings highlight the potential benefits of VR and 
mindfulness meditation for clients with FM. There is a great deal that remains unknown 
about the effectiveness of these pain management techniques. This pilot study will 
examine and compare the effectiveness of combining VR and meditation for improving 
symptoms of FM in adults. 
 
RESEARCH DESIGN AND METHODS 
We will recruit 25 older adults with knee osteoarthritis from Brigham and Women’s 
Hospital (BWH) to obtain 20 subjects with complete data collection. The sub-study will 
enroll 25 adults with fibromyalgia from BWH. 
Inclusion Criteria 
1. Describe the criteria that define who will be included in the study as a numbered list:  
1. Adults over the age of 60 years old (no upper limit) 
2. Diagnosis of chronic knee osteoarthritis with pain in at least one knee as primary 
condition 
3. English-speaking 
4. Willing and able to visit the Brigham and Women’s Pain Management Center site 
to participate in the study 
 
Exclusion Criteria 
1. Describe the criteria that define who will be excluded in the study as a numbered list:  
1. Received steroid injection within 2 weeks of VR session 
2. Unwilling to put on VR headset 
3. Diagnosed seizure disorder  
4. Cognitive impairment 
5. Hearing/visual deficit 
6. Active, contagious skin infection 

 
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7. Eye infections 
8. Has a pacemaker or defibrillator  
9. Has a hearing aid 
 
Sub-study: 
Inclusion Criteria: 
1. Adults ages 18 and older (no upper limit) 
2. Diagnosis of fibromyalgia with a minimum baseline pain level of 3 on an NPRS 
3. English-speaking 
4. Willing and able to visit the Brigham and Women’s Pain Management Center site 
on two separate occasions to participate in the sub-study 
Exclusion Criteria: 
1. Unwilling to put on VR headset 
2. Experience a seizure in the last 5 years 
3. Cognitive impairment 
4. Hearing/visual deficit 
5. Active, contagious skin infection 
6. Eye infections 
7. Has a pacemaker or defibrillator  
8. Has a hearing aid 
9. History of myocardial infarction or other serious cardiovascular condition 
10. Current peripheral neuropathy 
 
Study Design: 
Potential subjects that are interested in the study will be contacted, research staff will 
describe the study and go through a phone screen to make sure the subject is eligible to 
participate.  The day before the visit the subject will be contacted and will be read the 
Research Participant COVID-19 Screening Questionnaire. If they answer “Yes” to any 
questions between 2-5 they will need to contact research staff and reschedule their session 
time. 
Baseline Surveys 
At the in-person visit the participant will complete the following baseline questionniares 
collected via paper and pencil or REDCap, demographics, brief medical history, past 
experience with VR, the Pain Catastrophizing Scale (PCS),Survey of Pain Attitudes 
(SOPA), the Positive and Negative Affect Scale (PANAS), the PROMIS Emotional 
Distress Short Form, and the Brief Pain Inventory-Short Form. Answering the surveys 
will take 10-20 minutes. 
 
Virtual Tasks 
Participants will engage and follow along with a 10-20 minute guided meditation through 
the VR. The meditation program may include simulated movement, relaxing music, and 
the voice of a meditation guide. The research team member will supervise the session, 

 
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ensuring safety of the subject is maintained. 
 
Post-Intervention Surveys 
After the intervention, the subject will spend about 10-20-minutes filling out post-
intervention questionnaires via paper or electronically via REDCap. The questionnaires 
include, the subject’s VR experience, the User Engagement Scale, the Igroup Presence 
Questionnaire, the Simulator Sickness Symptoms, the Meditation Experience 
Questionnaire, 2 Numeric Rating Scale for pain, the PANAS, and the Patient Global 
Impression of Change (PGIC). Then, we will ask a short set of open-ended questions 
related to overall experience with the VR and meditation, feedback about the session, and 
willingness to utilize this intervention again.  We will audio tape the responses. 
Follow-Up Questionnaires 
Prior to ending the session we will determine if the subject prefers to complete the follow-
up questions by phone or by electronic questionnaire.  Within a few days after the 
intervention, we will contact the participant via their preferred method to complete the 
surveys at home.  These surveys include, the BPI-SF, the PGIC, the PANAS, the PROMIS 
Emotional Distress Short Forms for anxiety, depression and anger, the PCS. If we have not 
heard from subject within 24 hours after sending the follow-up surveys, we will contact 
participants to remind or assist them with completing follow-up questionnaires. These 
surveys will take about 10-20 minutes to complete. 
Sub-study Design: 
Potential subjects that are interested in the study will be contacted, research staff will 
describe the study and go through a phone screen to make sure the subject is eligible to 
participate.  The day before the visit the subject will be contacted and will be read the 
Research Participant COVID-19 Screening Questionnaire. If they answer “Yes” to any 
questions between 2-5 they will need to contact research staff and reschedule their session 
time 
Pre-intervention Tasks 
Upon completing the informed consent portion, vitals will be collected. Heart rate (HR) 
and blood pressure (BP) will be measured. Participant will complete the following surveys, 
A pain numerical rating scale (NRS) and the Pain Catastrophizing Scale (PCS) will all be 
used to evaluate the participants’ pain levels and their perceptions of pain. The Brief Pain 
Inventory-Short Form and the Fibromyalgia Impact Questionnaire both assess the 
influences pain has on their lives. Psychosocial factors will be measured using the Positive 
and Negative Affect Scale (PANAS) and the PROMIS Emotional Distress Short Form for 
anxiety, depression, and anger. 
Quantitative Sensory Testing (QST): 
QST measurements will include pressure pain sensitivity assessed using an analog 
algometer with a 1-cm2 rubber probe (FPK20, Wagner Instruments, Greenwich, CT, USA) 

 
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to quantify pressure pain thresholds (PPT) on the bilateral trapezius muscles and temporal 
summation in triplicate using a 40 g Neuropen Neurotip (Owen Mumford, Oxfordshire, 
United Kingdom) a train of 10 identical stimuli (1 Hz) using a metronome for timing. 
Virtual Task 
Participants will engage and follow along with a 10-20 minute guided meditation through 
the VR. The meditation program may include simulated movement, relaxing music, and 
the voice of a meditation guide. The research team member will supervise the session, 
ensuring safety of the subject is maintained. 
Non-Immersive Meditation  
For this session, participants will be seated facing a screen which will display the 
meditation imagery. They will engage and follow along with a 10-20 minute guided 
meditation. The meditation program will include relaxing visuals and music, and the voice 
of a guide.  
Post-Intervention Surveys 
Immediately following completion of the meditation sessions, vital signs will be taken for 
a second time (HR and BP). QST will then be performed for a second time. Three 
surveys will relate to the VR or non-immersive meditation experiences, the User 
Engagement Scale (UES), the Simulator Sickness Questionnaire (SSQ), and the 
Meditation Experience Questionnaire (MEQ). The participant will conclude by 
completing two questionnaires which are identical to some of the pre-intervention ones. 
Those are the pain numerical rating scale (NRS) and the PANAS. 
  
FORESEEABLE RISKS AND DISCOMFORTS 
Risks from VR: 
Contact with objects:  Participants’ vision is occluded by the Virtual Reality (VR) 
headset.  In general, they will perform the VR sitting, but the program may prompt them 
to move their arms and/or legs during the session.  
Simulator Sickness: Some participants experience simulator sickness while in the 
VR experience particularly after prolonged exposure. Simulator sickness symptoms can 
include fatigue, headache, eye strain, difficulty focusing, increased saliva in mouth, 
sweating, or nausea. This risk is moderate.  We have 3 methods to reduce this risk. 1) 
Dosage of VR for this study is between 10-20 minutes which has been reported as 
typically used in the literature, so risk for motion sickness is reduced. 2) Participants will 
complete the Simulator Sickness Questionnaire after each experience to monitor for 
motion sickness. 3) Participants can halt any VR at any time for any reason. 
Seizures: Some people may experience severe dizziness, seizures, eye or muscle 
twitching or blackouts triggered by light flashes or patterns during the VR.  This risk is 
quite small.  We have 2 ways to reduce this risk: 1) People with a known risk for seizures 

 
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will be excluded from this study. 2) If a subject experiences any of these symptoms we 
will immediately stop the VR.  We will provide any indicated immediate supportive care, 
we will recommend that they see a doctor, and they will be discontinued from the study. 
VR headset may be uncomfortable: Some people may find wearing the headset 
uncomfortable.  This risk is small.  We have 2 methods to reduce this risk:  1) we will 
work with the participant to adjust the headset to be as comfortable as possible. 2) 
participants can stop the VR experience at any time for any reason. 
Contamination:  The VR headset is tightfitting and in close contact with the skin 
of the face.  It is possible that participants may cross contaminate contagious skin or eye 
disorders.  This risk is small.  We have 2 methods to reduce this risk:  1) We will exclude 
people who have active, contagious skin or eye infections.  2) We will use a washable 
face protector for each visit.  Each device will be wiped with antibacterial cleaners after 
each use. 
Exposure to trigger in a VR experience: VR experiences can seem very real, and a 
participant may be exposed to an item or situation (e.g. heights) that can trigger an 
adverse reaction.  This risk is small.  We have 2 methods to reduce this risk.  1) There 
will be a variety of VR meditation experiences that participants can choose from so 
participants can pick experiences that appeal to them and do not appear to have any 
triggers. 2) Participants can halt any VR experience at any time for any reason. 
 
Risk of confidentiality:  
Loss of confidentiality is another risk associated with this study, although this risk will be 
minimized by the use of a unique study number and password protected and encrypted 
databases. Data extracted for analysis will also be de-identified and personal identifiers 
will only be available to study staff.  
EXPECTED BENEFITS 
Participants have the potential to experience reduced pain symptoms during and after the 
VR experience. This result is very probable.  Previous experiences suggest that the 
magnitude of this effect is, on average, large, and that the duration will be during the Virtual 
Reality experience and possibly up to a few hours or days afterwards.   
EQUITABLE SELECTION OF SUBJECTS 
The subjects recruited based on whether or not they meet the inclusion criteria above. These 
patients include people of all socioeconomic and ethnic categories, and no exclusions are 
made based on race, sex, or socioeconomic status.  
RECRUITMENT PROCEDURES 
We will recruit directly from the Pain Management Center through posted advertisements 
and ads on the waiting from TV. We will use the MGB Rally advertising platform to 

 
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provide interested subjects with information about the study, subjects can then provide 
their contact information. 
Subjects will receive up to a total of $40 for participating in this study.  Subjects will 
receive $30 for completing the Study Visit, and $10 for completing the final survey after 
the Visit. The payment will be in the form of an Amazon Gift card given at the end of the 
study. If  subjects withdraw before completing the study visit, they will not receive 
payment. 
 
CONSENT PROCEDURES 
Informed consent will be obtained by either a study physician or a research assistant 
associated with the study. A physician will be available at all times to answer questions 
that a subject may have. The subjects are given ample time to consider their participation 
and if they are hesitant, are encouraged to take the consent form home and read it carefully 
before making their final decision. No subjects are enrolled who are unable to provide 
consent. 
DATA AND SAFETY MONITORING 
The principal investigator and the co-investigators will review data and safety monitoring 
on a weekly basis. The study will be terminated when the target enrollment is reached.  
 
MONITORING AND QUALITY ASSURANCES 
Study outcomes will be collected via REDCap database. The trained staff who carry out 
the procedures will also carefully monitor the study throughout its duration. The team will 
evaluate the progress of the study, verify that the rights and well-being of the subjects are 
protected, verify that the reported clinical study data are accurate, complete and verifiable 
from source documents, and the conduct of the study is in compliance with the approved 
protocol and amendments. 
 
PRIVACY AND CONFIDENTIALITY 
The identity of patients is not revealed to any outside sources. All patient identifiers will 
be kept in a separate secure file location, password protected on the MGB servers. Only 
certified and trained study staff will have access to the information.  
During the 14-week study period, all study records will be stored in a locked file drawer 
accessible only to study personnel in the Brigham and Women’s Pain Management Center 
Research Lab.  Electronic records will be collected using REDCap and stored in a password 
protected files. No electronic addresses will be attached to material.  After the 14-week 
study period all de-identified data will be shared with Tufts University, data will be retained 

 
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at Tufts in 574 Boston Ave or other secure storage used by the department for a period of 
7 years.