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

NCT ID: NCT05726123

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2023-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia

Keywords

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neuromodulation fibromyalgia virtual reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control group (G1)

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

Group Type PLACEBO_COMPARATOR

The Exopulse Mollii Suit on a Fibromyalgia patient

Intervention Type DEVICE

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.

Suit group (G2)

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)

Group Type EXPERIMENTAL

The Exopulse Mollii Suit on a Fibromyalgia patient

Intervention Type DEVICE

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.

Suit + VR group (G3):

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.

Group Type EXPERIMENTAL

The Exopulse Mollii Suit on a Fibromyalgia patient

Intervention Type DEVICE

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.

Exercise group (G4):

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.

Group Type EXPERIMENTAL

The Exopulse Mollii Suit on a Fibromyalgia patient

Intervention Type DEVICE

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.

Interventions

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The Exopulse Mollii Suit on a Fibromyalgia patient

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.

Intervention Type DEVICE

Other Intervention Names

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a treatment session with the Exopulse Mollii Suit combined with VR on a Fibromyalgia patient a training session have on a Fibromyalgia patient

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Extremadura

OTHER

Sponsor Role lead

Responsible Party

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Alejandro Caña Pino

Clinical Proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alejandro Rubio Zarapuz

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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28922

Identifier Type: -

Identifier Source: org_study_id