Remote Gamified Sensory Perceptual Training for Patients With Fibromyalgia: a Feasibility Trial
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility of gamified sensory perceptual
      training in people with fibromyalgia. The primary aim is to determine the feasibility of
      at-home somatosensorial training for people with fibromyalgia. The researchers are
      determining the feasibility of using this device to decrease chronic neuropathic pain in
      people with fibromyalgia. The secondary aim is to survey participants' subjective report of
      clinical change after this program.
    

Detailed description: 
      Fibromyalgia is a pain syndrome characterized by central sensitization, and hypersensitivity
      to nociceptive stimuli. In people with fibromyalgia, objective measures of sensory perception
      are often impaired. For example, somatosensory temporal discrimination thresholds are
      elevated, and this correlates with increased widespread pain and severity of other symptoms
      including fatigue, sleep quality, cognitive symptoms, somatic symptoms and decreased
      functional status. Sensory-Cognitive training may reduce symptoms by improving attentional
      modulation of somatosensory signals, improving precision of sensory discrimination, and
      altering affective processing of somatosensation. The objective of this study is to evaluate
      the feasibility of the TrainPain program as a somatosensory therapy for people with
      fibromyalgia.. This study plans to enroll 30 participants between the ages of 18 and 65 who
      are diagnosed with fibromyalgia and have been experiencing chronic pain with an NRS rating of
      4/10 for at least 3 months. All participants who agree to participate in this study will
      answer a set of baseline questionnaires (PEG, FAS) about their symptoms at the time of
      inclusion. Participants will also receive the device, and view a demonstration of how to use
      the technology. The technology consists of two components; (1) an application downloaded to
      the participants' smartphone and (2) two vibrational devices to be placed on the body of the
      participant, connected to the application via bluetooth. Participants will use this
      technology once daily for 28 days. Participants will complete a 15 minute sensory training
      session using the provided technology; additionally, participants will receive daily text
      messages to promote pain self-management, and program adherence. Participants will also
      complete the PEG questionnaire once weekly. After 28 days study team members will conduct a
      virtual follow-up visit. In that visit, participants will complete the same questionnaires as
      at baseline (PEG, FAS), as well as a question on their perception of clinical change (PGIC).
      Participants will also be asked to complete the system usability scale and provide a net
      promoter score. Finally, participants will complete a subjective feedback questionnaire where
      they will rate whether participating in this program was time well spent and enjoyable. The
      primary aim is to determine the feasibility of at-home somatosensorial training for people
      with fibromyalgia. The secondary aim is to survey participants' subjective report of clinical
      change after this.
    

Intervention name(s): TrainPain
Intervention type(s): Device
Intervention description(s): Participants will use gamified sensory perceptual training technology once daily for 28 days. This will involve participants completing a 15 minute sensory training session using the provided technology and viewing a 5 minute web based pain management lesson; additionally, participants will receive daily text messages. The device used in this study has two components. The first is a video game that can be downloaded onto any smartphone device. The second component is two vibrational devices that can be attached to the arms, legs, upper back, and lower back.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Gamified; Somatosensory; Temporal discrimination; Cognitive training; Chronic Pain