Effectiveness of Virtual Reality for chronic pain in patients with inflammatory arthritis; a randomized controlled pragmatic clinical trial

Inflammatory rheumatic diseases are often associated with factors that limit
patients' quality of life and sense of health, with pain being the most
important factor. Conditions such as rheumatoid arthritis, psoriatic arthritis,
and spondyloarthritis are associated not only with pain during joint
inflammation, but sometimes with chronic pain even in inactive disease and in
the absence of damage. Painkillers and anti-inflammatory drugs play a crucial
role in the treatment of inflammatory arthritis, but a subgroup of patients
still suffer from chronic pain despite taking medications, which often leads to
opioid overuse. Various alternative treatments have been investigated, such as
pain education, relaxation techniques and cognitive behavioral therapy.
However, most are time-consuming and dependent on the availability of expert
healthcare providers. Therefore, there is a need for innovative methods to
self-administer such treatments on demand. An example of such an innovative
method is Virtual Reality (VR). VR is an artificial construction of a 3D
environment created by computer technology. An immersive VR system consists of
a 3D headset with environmental sensors combined with headphones, allowing
users to fully engage and move within the VR environment. VR is increasingly
used in the multidisciplinary treatment of pain. Using VR, the perception of
pain can be reduced by educating about its cause, providing a distracting
stimulus, regulating nociceptive neural signals, and increasing the sense of
control over pain. One of these VR programs is Reducept, which aims to relieve
chronic pain through pain education and psychotherapy. Previous pilot studies
have demonstrated the applicability of the Reducept VR program in arthritis
patients, as well as a reduction in pain intensity in a small sample. These
pilot studies warrant a formal investigation into the efficacy of the Reducept
VR program in patients with inflammatory arthritis who experience chronic pain
despite low disease activity.

The primary objective of this study is:
- to measure the effect of the VR program Reducept on the NRS pain score in
patients with inflammatory arthritis with chronic pain despite low disease
activity.

The secondary objectives are:
- to measure the direct effect of the VR program Reducept on the NRS pain score
(before and after use of VR).
- to measure the effect of the VR program Reducept on the NRS pain score during
the day.
- to measure the effect of the VR program Reducept on fatigue and the use of
painkillers.
- to measure the effect of the Reducept VR program on quality of life, physical
functioning and pain catastrophizing.
- to measure the effect of the expected outcomes of the VR program Reducept on
the actual outcome after using Reducept.
- to measure the effect of the VR program Reducept on self-efficacy.
- to investigate the association between continuous measurement of mobility and
patient-reported data on pain, fatigue and physical functioning.
- to measure the usability and acceptance of the ESM technique and VR among
rheumatic patients.

This study is a randomized, controlled, pragmatic clinical trial. Patients will
be randomized 1:1 into the VR intervention or the usual care group, with an
emphasis on assessing the immediate and longer-term effects of the VR program
Reducept on pain, fatigue and the use of pain medication. Patients in the
intervention group use the VR headset with the Reducept application for 8
weeks; the first 4 weeks at least three times a week for 15 - 20 minutes and
the last 4 weeks patients can use it 'on-demand'. The primary outcome measure
NRS pain score and the secondary outcome measure fatigue and medication use are
measured using the Experience Sampling Method (ESM), implemented via the mobile
health smartphone application Avicenna. Using ESM, self-reported data can be
collected regularly. In the VR group, pain is measured both around the use of
Reducept and during the day. The patient can self-report the NRS pain score at
any time via the app, with instructions to do this immediately before and after
using the VR program Reducept. The control group is asked weekly to complete a
digital questionnaire about their pain, fatigue and medication use. Eight
questionnaires are also completed during a first appointment and at an
appointment after 8 weeks.

For this study, the Pico G2 4K VR headset will be used in combination with the
VR training app Reducept. The Pico G2 is an all-in-one VR headset with an
ergonomic design and a simple remote control to start the app. The Reducept
training app focuses on training the brain and learning to improve the control
over one*s body, thereby gaining more control over pain symptoms. It provides
an explanation of pain, followed by a virtual journey through one*s own body,
spinal cord, nerve pathways, and brain to deactivate pain signals. Reducept
incorporates pain education with psychotherapies like cognitive behavioural
therapy, acceptance commitment therapy and eye movement desensization and
reprocessing.

Patients participating in this study will be required to visit the hospital
twice for approximately 60 minutes. The control group must complete a short
questionnaire of 3-5 minutes every week. The VR group must complete a short
questionnaire of 3-5 minutes at least twice a day for eight weeks. In addition,
these participants are asked to use the VR program for 8 weeks. There may also
be a chance that the participants will experience cybersickness. However, this
is considered unlikely as previous pilot studies have shown that a majority of
participants reported no cybersickness symptoms.