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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
60
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.
Alejandro Rubio Zarapuz
Madrid, Spain
Pain intensity
VAS (Visual analog scale)
Time frame: 8 weeks
Postural stability
Baropodometric platform Namrol
Time frame: 8 weeks
Heart rate variability
RS800CX monitor (Polar Inc., Kempele, Finland). The Kubios HRV software (v. 3.3)
Time frame: 8 weeks
Tissue oxygenation
Oximeter. Moxy-3
Time frame: 8 weeks
Thermographic distribution
Camera E85 24" LENS. TELEDYNE FLIR. FLIR E8-XT system
Time frame: 8 weeks
Muscle activity
MDurance surface electromyography.
Time frame: 8 weeks
Level of depression and anxiety
Depression Anxiety Stress Scale
Time frame: 8 weeks
Body composition
Inbody 270
Time frame: 8 weeks
Respiratory variables (forced expiratory volume in 1 second (FEV1), 6 seconds (FEV6) and the ratio of both these values (FEV1/FEV6))
To measure the following variables a spirometry test was conducted with a Vitalograph Asma1 spirometer
Time frame: 8 weeks
Cortical arousal
Measured trough the Critical Flicker Fusion Threshold (CFFT) in a viewing chamber (Lafayette Instrument Flicker Fusion Control Unit Model 12021)
Time frame: 8 weeks
Functional test
chair stand test
Time frame: 8 weeks
Functional test
Handgrip strength test
Time frame: 8 weeks
Functional test
10m up and go test
Time frame: 8 weeks
Functional test
One leg balance
Time frame: 8 weeks
Pressure pain threshold
The algometer used was a Wagner FPKTM algometer with a blunt rubber tip of 1cm. The lateral epicondyle (2 cm distal to the epicondyles), and the inside of the knee (at the medial fat pad proximal to the joint line)
Time frame: 8 weeks
Salivary Biomarkers
Unstimulated whole saliva was collected at rest and after exercise for each participant by direct draining into an ice-cold collection tube (pre-weighted) for 3 min After saliva collection, tubes with the samples were weighted (for saliva flux evaluation, mL/min), centrifuged at 1500× g for 10 min to remove food and cell debris, and the supernatant was stored at -20 ◦C until analysis
Time frame: 8 weeks
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