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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05726123
• Other study ID #: 28922
• Status: Completed
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: November 2023
• Source: University of Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 30, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Spain	Alejandro Rubio Zarapuz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Extremadura

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	VAS (Visual analog scale)	8 weeks
Primary	Postural stability	Baropodometric platform Namrol	8 weeks
Primary	Heart rate variability	RS800CX monitor (Polar Inc., Kempele, Finland). The Kubios HRV software (v. 3.3)	8 weeks
Primary	Tissue oxygenation	Oximeter. Moxy-3	8 weeks
Primary	Thermographic distribution	Camera E85 24" LENS. TELEDYNE FLIR. FLIR E8-XT system	8 weeks
Primary	Muscle activity	MDurance surface electromyography.	8 weeks
Primary	Level of depression and anxiety	Depression Anxiety Stress Scale	8 weeks
Primary	Body composition	Inbody 270	8 weeks
Primary	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	8 weeks
Primary	Cortical arousal	Measured trough the Critical Flicker Fusion Threshold (CFFT) in a viewing chamber (Lafayette Instrument Flicker Fusion Control Unit Model 12021)	8 weeks
Primary	Functional test	chair stand test	8 weeks
Primary	Functional test	Handgrip strength test	8 weeks
Primary	Functional test	10m up and go test	8 weeks
Primary	Functional test	One leg balance	8 weeks
Primary	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)	8 weeks
Primary	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	8 weeks