The Efficacy, Acceptability, Tolerability and Feasibility of a Therapeutic Virtual Reality Application
Condition: Back Pain Lower Back Chronic; Quality of Life
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      This study evaluates the effect of therapeutic Virtual Reality (VR) on quality of life of 60
      patients with non-specific chronic low-back pain. 30 patients will be included in the
      intervention group. These patients will use Reducept, a therapeutic virtual reality
      application based on diverse cognitive therapies (ACT, mindfulness, EMDR, hypnotherapy), at
      home over a period of 28 days, for at least 10 minutes each day. This will be an add-on
      intervention next to standard care, while the patient is waiting to receive actual treatment
      for chronic pain. 30 patients in the control group will only receive standard care, whilst
      waiting to receive actual treatment for their chronic pain. Intervention and control group
      will be compared on a number of outcome measures related to quality of life before using VR,
      during VR use, just after use and 4 months after final use. This explorative study is
      necessary to get first insights as a basis for a confirmative study.
    

Detailed description: 
      Rationale:

      21,2% of the Dutch population is suffering from chronic low-back pain. 90% of these patients
      suffers from chronic low-back pain not attributable to a recognisable, specific pathology
      (non-specific low-back pain). 30-40% of all patients suffering from chronic pain visit their
      GP for treatment. Treatment includes mostly analgesics, in particular NSAIDs and opioids.

      Adequate treatment of chronic pain is important as chronic pain negatively impacts, amongst
      others, quality of life, activities of daily living and feelings of helplessness. A
      systematic review by Bala et al. however shows that chronic pain treatment is often
      inadequate. Moreover, each different type of analgesic has its own associated side effects.
      NSAIDs increase the risk of cardiovascular and gastrointestinal complications. Common side
      effects of opioid analgesics include sedation, dizziness, nausea, vomiting, constipation,
      physical dependence, and even cases of hyperalgesia.

      Recently, more attention has been given to psychological interventions for relieving chronic
      pain. A systematic review by Castelnuovo et al. shows the efficacy of a range of
      psychological interventions, including acceptance and commitment therapy (ACT),
      mindfulness-based interventions, hypnotherapy, eye movement and desensitization and
      reprocessing (EMDR) therapies and virtual reality based interventions. All of these
      psychological interventions focus on changing people's attitudes, feelings and behaviors on
      chronic pain, to improve their quality of life.

      The first psychological intervention is the commonly used acceptance and commitment therapy
      (ACT). ACT is a cognitive behavioral therapy for treating chronic pain that uses
      exposure-based and experiential methods aiming at improving patients' abilities to cope with
      their chronic pain. Several systematic reviews indicate that ACT is effective in improving
      health outcomes of chronic pain patients. Mindfulness-based interventions seem to work as
      well for chronic pain relief. This set of interventions aims at learning strategies for pain
      awareness and acceptance. Furthermore, hypnotherapy is a mind-body based intervention that
      uses hypnoses to learn patients to cope with their pain. It focuses attention away from pain,
      thereby blocking its experience. Hypnotherapy seems effective in reducing pain experience.
      Then, eye movement desensitization and reprocessing (EMDR) is another psychotherapeutic
      approach in treating chronic pain. EMDR has already shown to be effective in treating
      posttraumatic stress disorder, and has recently as well been introduced as a treatment for
      chronic pain. Early research findings indicate EMDR to be effective in treating chronic pain.

      Finally, one of the most recent fields of inquiry in treating chronic pain by means of
      psychological interventions is Virtual Reality. VR consists of a Head Mounted Device (HMD)
      and a sound system which immerses the user in a three-dimensional (3D) virtual world. There
      are multiple mechanisms behind the efficacy of VR in treating chronic pain. The most commonly
      studied mechanism is distraction. VR seems to be effective in reducing pain via distraction
      as it diverts attention away from pain. As both the VR application and the pain require
      attention and the brain has only limited attentional capacity, less attention is available
      for pain processing. In this manner, it reduces current feelings of pain, anxiety and stress.
      Though, the distraction mechanism only diverts attention away from pain shortly. To actually
      treat chronic pain by means of VR, it seems that other strategies, apart from distraction,
      are required.

      Several studies aimed to find alternative mechanisms behind pain reduction by VR. The use of
      psychological interventions in VR, such as ACT or hypnosis, appears to be effective. Although
      the context of VR is different from traditional psychotherapy, the idea of how change occurs
      is not. Moreover, the immersiveness of VR provides opportunities to even better influence
      cognitions and emotions of patients suffering from chronic pain. Multiple virtual reality
      interventions have been designed with this knowledge in mind. A proof-of-concept study by
      Gromala et al., for example, looked into the application Virtual Meditative Walk (VMW). VNW
      focuses on mindfulness-based stress reduction via VR. The user study shows VNW's efficacy
      compared to non-VR interventions. Likewise, Guarino et al. proved that using virtual
      mindfulness therapy eight times over a period of a month is effective in chronic pain
      reduction. Therapeutic hypnosis has as well been tested in several case report studies. All
      conclude that virtual reality hypnosis seems to be effective in dealing with chronic pain.

      The VR serious game Reducept is a novel psychological VR intervention for treating chronic
      pain. It incorporates several psychological therapies into one application: hypnotherapy,
      mindfulness, ACT and EMDR. Reducept has been made in co-creation with patients, researchers,
      psychologists and developers and can be installed and played on a VR goggles. It consists of
      an education module and three games.

        -  Education: Reducept provides its players with information about the biological
           mechanisms underlying chronic pain. Learning about chronic pain helps to cope with it in
           daily life.

        -  Control: Reducept's first game has been based on the mechanisms of hypnotherapy. The
           patient should shoot away painful stimuli in the nervous system. By visualizing their
           pain, they learn to control and cope with it.

        -  Relaxation: the second game within Reducept is a mindfulness-based intervention. It
           takes place in the spinal cord. Players should collect positive neurotransmitters and
           focus on their respiration rate.

        -  Processing: game three has been based on the mechanisms of ACT and EMDR. It asks players
           to recover negative patterns in the brain. Players have to switch attention between the
           pain and the game, helping them to decrease their experience of pain.

      This study aims to gain a first understanding in the ability of the therapeutic VR
      intervention Reducept to treat chronic low-back pain. It will define a wide range of outcome
      measures, including quality of life indicators, pain, stress and anxiety measures and
      measures on ability to execute daily activities. What outcome measures does it affect? What
      outcome measures will be left unaffected? Moreover, tolerability, feasibility and
      acceptability of Reducept in relation to different patient characteristics (age, gender,
      Motivaction profiling) will be measured to understand which patients might benefit most from
      virtual reality based psychological interventions. The study focuses on patients with
      non-specific chronic low-back pain as this group represents a large part of all chronic pain
      patients. This explorative study is necessary as an input for future studies on the actual
      effects of therapeutic virtual reality interventions on quality of life of patients.

      Objective:

      To investigate whether a therapeutic virtual reality application can improve the quality of
      life of people suffering from non-specific chronic low-back pain, compared to a control
      condition.

      Study design:

      This explorative study uses a randomised controlled parallel design (1:1). Participants will
      be randomly assigned to either the control group or the intervention group. In the control
      group, participants are placed on the waiting list to receive the common treatment to handle
      their chronic pain. As they are placed on the waiting list, they will receive no therapeutic
      treatment yet (apart from the during intake prescribed physiotherapy and medication).
      Participants placed in the intervention group, who are also placed on the waiting list and
      only receive, when prescribed, physiotherapy and medication, will use the therapeutic virtual
      reality intervention meanwhile at home during a period of 28 days for at least ten minutes
      each day and in addition the education module at least during day 1 (which lasts 25 minutes).
      The randomisation is not blinded: both researchers and participants know which participants
      are part of the intervention and control group.

      Study population:

      Adult patients, males and females, suffering from daily non-specific chronic low-back pain
      are eligible for this study. Patients' pain should have last for at least three months.
      Patients should report a pain score of ≥4 during the intake questionnaires filled in before
      intake at the Rijnstate Pijncentrum.

      Intervention (if applicable):

      Participants will be randomly assigned to either the intervention group or the control group.
      Participants assigned to the intervention group will receive virtual reality glasses with the
      Reducept application. They are asked to use the therapeutic virtual reality intervention at
      home over a period of 28 days starting the day after collecting the virtual reality goggles.
      Participants are asked to use the therapeutic virtual reality intervention at least once a
      day for ten minutes. In addition, they should, on the first day, and preferably during more
      days, watch the whole education program which lasts 25 minutes. Participants can decide
      themselves to use the application more often. Participants assigned to the control group will
      receive no intervention, they are, just as the intervention group, placed on the waiting list
      to receive normal treatment.

      Unfortunately, it is not possible to provide all patients with the opportunity to use the
      virtual reality application, as the design requires a control group that does not use it over
      the study period.

      The investigators will study the possibility of continuing the virtual reality treatment for
      all participants want-ing to after finishing this study. At least they will be able to buy
      themselves the virtual reality glasses for using the therapeutic virtual reality.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness:

      There is no risk involved in exposure to the therapeutic virtual reality application.
      Participants can leave the study at any time for any reason if they wish to do so without any
      consequences. As mentioned before, the burden for participants associated with this study is
      mainly related to measurements of endpoints, which will take approximately 30-45 minutes
      three times over a period of five months. The intervention group will spend at least ten
      minutes a day on the therapeutic virtual reality application and in addition on day 1 25
      minutes.. As explained in the rationale, no or only minimal adverse effects from this
      intervention are expected.
    

Intervention name(s): Reducept, virtual reality
Intervention type(s): Device
Intervention description(s): The VR serious game Reducept is a novel psychological VR intervention for treating chronic pain. It incorporates several psychological therapies into one application: hypnotherapy, mindfulness, ACT and EMDR. Reducept has been made in co-creation with patients, researchers, psychologists and developers and can be installed and played on a VR goggles. It consists of an education module and three games.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned (1:1) to either the intervention group or the control group. Both intervention and control group are placed on the waiting list (approximate time of waiting is 6 weeks) to receive treatment. Meanwhile, our study will be executed. Intervention group: use of virtual reality intervention at home over a period of 28 days (with a maximum of 35 days) at least ten minutes a day (excluding day 1, in which the participants should do the entire education module of 25 minutes) and in addition, when participants feel the need. The control group: no intervention, patient is waiting to receive normal chronic pain treatment. Randomisation is not blinded: both researchers and participants know which participants are part of the intervention and control group. Randomisation will take place using a computerised randomisation list with variably sized blocks, directly after providing oral informed consent.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual reality; Quality of life; Back pain