Therapeutic Intervention With Neuromodulation and Inverse Virtual Reality in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      INTRODUCTION: Fibromyalgia is a chronic condition of generalised pain that entails
      significant limitations in daily and social life due to pain, fatigue, sleep disturbances and
      mood alterations. Rehabilitation programmes try to alleviate the symptoms and seek
      intervention methodologies that contribute to improving the quality of life and reduce the
      socio-economic cost. Innovation, technology and new neurophysiologically based therapeutic
      interventions are being integrated into rehabilitation clinics and although there are
      foundations and research into the potential benefits that can be obtained, research is still
      needed to determine intervention protocols that are more effective and efficient. The company
      XXX has state-of-the-art technology and equipment in order to be able to offer high quality
      and professional services in Extremadura and is motivated to participate in scientific,
      innovation and development projects in order to analyse and take advantage of the great
      potential of the equipment and thus offer it to society. OBJECTIVE: this project aims to
      compare the influence of the use of immersive virtual reality combined with Exopulse
      neuromodulation suits on patients with fibromyalgia. METHODOLOGY: a clinical trial is
      proposed with probabilistic random assignment in three groups, a control group (G1) in which
      patients will wear the suit on, but it will not emit any type of current. A suit group (G2),
      in which only the neuromodulation suit will be used, and an experimental group (G3) in which,
      in addition to the neuromodulation suit, virtual reality glasses will be used in full
      immersive mode. The variables to be analysed are: pain, postural stability, muscle activity,
      muscle oxygenation, thermographic distribution, heart rate variability, stress, anxiety. The
      acute effects will be analysed after one intervention session (pre-post intervention of one
      session) and the effects after a programme of 8 sessions. RESOURCES: The intervention
      equipment will be provided by the company and the assessment equipment by the research group.
    


Intervention name(s): The Exopulse Mollii Suit on a Fibromyalgia patient
Intervention type(s): Device
Intervention description(s): The present study consists of a comparative, randomized, controlled and clinical trial conducted to explore and compare the acute and chronic effects a treatment session with the Exopulse Mollii Suit, a treatment session with the Exopulse Mollii Suit combined with VR and a training session have on a Fibromyalgia patient.
Other intervention name(s): a treatment session with the Exopulse Mollii Suit combined with VR on a Fibromyalgia patient; a training session have on a Fibromyalgia patient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: neuromodulation; fibromyalgia; virtual reality