Therapeutic Intervention With Neuromodulation and Inverse Virtual Reality in Patients With Fibromyalgia

University of Extremadura

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: The Exopulse Mollii Suit on a Fibromyalgia patient

Study type: Interventional

Funder types: Other

Identifiers

NCT05726123

28922

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 65 years.
• Diagnosis of fibromyalgia at least 3 months in advance.
• Minimum perceived pain intensity of 3/10 according to the Numeric Pain Rating Scale.

Exclusion criteria

• Having received physiotherapy 4 weeks prior to data collection.
• Personal Psychological Apprehension Scale (PPAS) score greater than 37.5.
• Contraindication to the use of electrotherapy.
• Use of opioid medication that may generate changes at the level of the Autonomic Nervous System.
• Ineligibility to participate in the study for other reasons deemed appropriate by the investigators.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups, including a placebo group

Control group (G1)

Placebo Comparator group

Description:

Control group (G1): in which the suit shall be switched on, but with the current of all electrodes at 0 mA.

Treatment:

Device: The Exopulse Mollii Suit on a Fibromyalgia patient

Suit group (G2)

Experimental group

Description:

Suit group (G2): will only receive treatment with the neuromodulation suit at the intensity preset by the manufacturer and according to the assessment criteria. The duration of the treatment will be 1 hour. Exopulse Molly Suit with all 58 electrodes active with an intensity of 2 milliamperes (mA) and pulse width of 30 milliseconds (ms)

Treatment:

Device: The Exopulse Mollii Suit on a Fibromyalgia patient

Suit + VR group (G3):

Experimental group

Description:

Suit + VR group (G3): the intervention on this group was carried out in the same way as the suit group. However, the session was different as the participant wore VR glasses besides wearing the suit for an hour. The patient sees the same room he is in and a person performing a series of exercises he must follow as indicated by the video by video and voice commands. As exercise are performed in a laying position the patient must stay in this position for the whole session.

Treatment:

Device: The Exopulse Mollii Suit on a Fibromyalgia patient

Exercise group (G4):

Experimental group

Description:

Exercise group: The procedure carried out is the same as in the suit group, but the session performed was a 1-hour session of strength exercise carried out by a certified professional.

Treatment:

Device: The Exopulse Mollii Suit on a Fibromyalgia patient