Immersive Virtual Reality and Chronic Back Pain
Condition: Chronic Back Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      In the proposed project the investigators will evaluate the feasibility of Immersive Virtual
      Reality (IVR) and assess the initial effects of IVR on symptoms, affect, and tolerance to
      cutaneous stimuli. In this single-arm trial, the investigators 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. Afterward, in a single experimental session, they will participate in
      two counterbalanced IVR sessions: one 10-minute and one 20-minute. Immediately after each
      session the investigators 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
      the 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.
    

Detailed description: 
      Visit 1-Remote: Consent. Random assignment: Subjects will complete informed consent and data
      collection of baseline information (demographics, medical history, perceptions of pain, and
      experiences with VR), surveys on pain, Pain interference, fatigue, and affect. The
      investigators will also help the participant upload the EMA technology onto their personal
      phone or tablet. Subjects will then be randomly assigned to receive either the 10- minute IVR
      session first or the 20-minute IVR session first. Visit 1 will take between 45 and 60
      minutes.

      Multiple Baseline EMA-Remote: Visit 2 will be scheduled 1-2 weeks later. During the time
      between visits the investigators 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 15 minutes.

      Visit 2-In person: pre Survey/Quantitative Sensory Testing (QST); First VR visit; post
      Survey/QST. The investigators will collect current pain, pain interference, fatigue and
      affect, and Quantitative Sensory Testing (QST). QST involves cutaneous (skin) psychophysical
      (semi-subjective) testing to assess sensory and pain perception pathways. QST quantifies the
      thresholds of detection of stimuli, the perceived intensity, and the temporal summation
      (changes in perception over multiple applications). These pain testing procedures are
      widely-accepted, non-invasive, and non-tissue damaging. The investigators will complete two
      types QST. 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. The
      investigators 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. All subjects will take part in two VR experiences (10 min and 20 min) for a
      total of 30-minutes in VR. After each experience subjects will rate their current pain,
      fatigue, and affect, and the investigators will complete QST. At the end of both sessions the
      subjects will rate their experiences of immersion using the Igroup Presence Questionaire,
      engagement using the Use Engagement Scale (UES), and simulation tolerance using the Simulator
      Sickness Questionnaire (SSQ). The investigators will also ask a series of open-ended
      questions about the participant's experiences with IVR and participation in the study. These
      will include questions about their enjoyment, perceptions of pain, and what they liked/did
      not like about the IVR experience as well as questions about the burden of being in the
      study. Visit 2 will take 1.5 to 2 hours

      Post Visit 2 EMA-Remote: Subjects will complete three more days (72 hours) of 3x a day
      prompts for pain, fatigue and affect.

      Visit 3-In person: pre Survey/Quantitative Sensory Testing (QST); Second VR visit; post
      Survey/QST

      Post Visit 3 EMA-Remote: Subjects will complete 2 more days (48 hours) of 3x a day prompts
      for pain, fatigue and affect.
    

Intervention name(s): Immersive Virtual Reality
Intervention type(s): Device
Intervention description(s): Immersive Virtual Reality
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment