Skip to main content
OpenTrials
Completed

NCT Number: NCT05726123

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alejandro Rubio Zarapuz

Madrid, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Exopulse Mollii Suit on a Fibromyalgia patient

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.

Other names: a treatment session with the Exopulse Mollii Suit combined with VR on a Fibromyalgia patient, a training session have on a Fibromyalgia patient

Primary outcomes

  1. Pain intensity

    Time frame: 8 weeks

    VAS (Visual analog scale)

  2. Postural stability

    Time frame: 8 weeks

    Baropodometric platform Namrol

  3. Heart rate variability

    Time frame: 8 weeks

    RS800CX monitor (Polar Inc., Kempele, Finland). The Kubios HRV software (v. 3.3)

  4. Tissue oxygenation

    Time frame: 8 weeks

    Oximeter. Moxy-3

  5. Thermographic distribution

    Time frame: 8 weeks

    Camera E85 24" LENS. TELEDYNE FLIR. FLIR E8-XT system

  6. Muscle activity

    Time frame: 8 weeks

    MDurance surface electromyography.

  7. Level of depression and anxiety

    Time frame: 8 weeks

    Depression Anxiety Stress Scale

  8. Body composition

    Time frame: 8 weeks

    Inbody 270

  9. Respiratory variables (forced expiratory volume in 1 second (FEV1), 6 seconds (FEV6) and the ratio of both these values (FEV1/FEV6))

    Time frame: 8 weeks

    To measure the following variables a spirometry test was conducted with a Vitalograph Asma1 spirometer

  10. Cortical arousal

    Time frame: 8 weeks

    Measured trough the Critical Flicker Fusion Threshold (CFFT) in a viewing chamber (Lafayette Instrument Flicker Fusion Control Unit Model 12021)

  11. Functional test

    Time frame: 8 weeks

    chair stand test

  12. Functional test

    Time frame: 8 weeks

    Handgrip strength test

  13. Functional test

    Time frame: 8 weeks

    10m up and go test

  14. Functional test

    Time frame: 8 weeks

    One leg balance

  15. Pressure pain threshold

    Time frame: 8 weeks

    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)

  16. Salivary Biomarkers

    Time frame: 8 weeks

    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

Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Official study title

Physiological and Functional Effects of Therapeutic Intervention With Neuromodulation Suit With and Without Combination of Reverse Virtual Reality in Fibromyalgia Patients.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2023
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.