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

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
The Exopulse Mollii Suit on a Fibromyalgia patient
Sponsored by
University of Extremadura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring neuromodulation, fibromyalgia, virtual reality

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Alejandro Rubio ZarapuzRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Control group (G1)

Suit group (G2)

Suit + VR group (G3):

Exercise group (G4):

Arm Description

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

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)

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 19, 2023
Last Updated
February 9, 2023
Sponsor
University of Extremadura
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1. Study Identification

Unique Protocol Identification Number
NCT05726123
Brief Title
Therapeutic Intervention With Neuromodulation and Inverse Virtual Reality in Patients With Fibromyalgia
Official Title
Physiological and Functional Effects of Therapeutic Intervention With Neuromodulation Suit With and Without Combination of Reverse Virtual Reality in Fibromyalgia Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Extremadura

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
neuromodulation, fibromyalgia, virtual reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group (G1)
Arm Type
Placebo Comparator
Arm Description
Control group (G1): in which the suit shall be switched on, but with the current of all electrodes at 0 mA.
Arm Title
Suit group (G2)
Arm Type
Experimental
Arm 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)
Arm Title
Suit + VR group (G3):
Arm Type
Experimental
Arm 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.
Arm Title
Exercise group (G4):
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
The Exopulse Mollii Suit on a Fibromyalgia patient
Other Intervention Name(s)
a treatment session with the Exopulse Mollii Suit combined with VR on a Fibromyalgia patient, a training session have on a Fibromyalgia patient
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
VAS (Visual analog scale)
Time Frame
8 weeks
Title
Postural stability
Description
Baropodometric platform Namrol
Time Frame
8 weeks
Title
Heart rate variability
Description
RS800CX monitor (Polar Inc., Kempele, Finland). The Kubios HRV software (v. 3.3)
Time Frame
8 weeks
Title
Tissue oxygenation
Description
Oximeter. Moxy-3
Time Frame
8 weeks
Title
Thermographic distribution
Description
Camera E85 24" LENS. TELEDYNE FLIR. FLIR E8-XT system
Time Frame
8 weeks
Title
Muscle activity
Description
MDurance surface electromyography.
Time Frame
8 weeks
Title
Level of depression and anxiety
Description
Depression Anxiety Stress Scale
Time Frame
8 weeks
Title
Body composition
Description
Inbody 270
Time Frame
8 weeks
Title
Respiratory variables (forced expiratory volume in 1 second (FEV1), 6 seconds (FEV6) and the ratio of both these values (FEV1/FEV6))
Description
To measure the following variables a spirometry test was conducted with a Vitalograph Asma1 spirometer
Time Frame
8 weeks
Title
Cortical arousal
Description
Measured trough the Critical Flicker Fusion Threshold (CFFT) in a viewing chamber (Lafayette Instrument Flicker Fusion Control Unit Model 12021)
Time Frame
8 weeks
Title
Functional test
Description
chair stand test
Time Frame
8 weeks
Title
Functional test
Description
Handgrip strength test
Time Frame
8 weeks
Title
Functional test
Description
10m up and go test
Time Frame
8 weeks
Title
Functional test
Description
One leg balance
Time Frame
8 weeks
Title
Pressure pain threshold
Description
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
Title
Salivary Biomarkers
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro Rubio Zarapuz
Phone
924289300
Email
Alejandro.rubio.z@hotmail.com
Facility Information:
Facility Name
Alejandro Rubio Zarapuz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Rubio Zarapuz

12. IPD Sharing Statement

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

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