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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Pain intensity
Timeframe: 8 weeks
Postural stability
Timeframe: 8 weeks
Heart rate variability
Timeframe: 8 weeks
Tissue oxygenation
Timeframe: 8 weeks
Thermographic distribution
Timeframe: 8 weeks
Muscle activity
Timeframe: 8 weeks
Level of depression and anxiety
Timeframe: 8 weeks
Body composition
Timeframe: 8 weeks
Respiratory variables (forced expiratory volume in 1 second (FEV1), 6 seconds (FEV6) and the ratio of both these values (FEV1/FEV6))
Timeframe: 8 weeks
Cortical arousal
Timeframe: 8 weeks
Functional test
Timeframe: 8 weeks
Functional test
Timeframe: 8 weeks
Functional test
Timeframe: 8 weeks
Functional test
Timeframe: 8 weeks
Pressure pain threshold
Timeframe: 8 weeks
Salivary Biomarkers
Timeframe: 8 weeks