FibromyalgiaNCT05726123
Therapeutic Intervention With Neuromodulation and Inverse Virtual Reality in Patients With Fibromyalgia
A study testing The Exopulse Mollii Suit on a Fibromyalgia patient in people with Fibromyalgia, run by University of Extremadura at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- The Exopulse Mollii Suit on a Fibromyalgia patient
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 20 Dec 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Physiological and Functional Effects of Therapeutic Intervention With Neuromodulation Suit With and Without Combination of Reverse Virtual Reality in Fibromyalgia Patients.
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.
- Conditions
- Fibromyalgia
- Being tested
- The Exopulse Mollii Suit on a Fibromyalgia patient
- Keywords
- neuromodulation, fibromyalgia, virtual reality
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Exopulse Mollii Suit on a Fibromyalgia patientDevice
Also called a treatment session with the Exopulse Mollii Suit combined with VR on a Fibromyalgia patient, a training session have 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group (G1) | Placebo comparator | Control group (G1): in which the suit shall be switched on, but with the current of all electrodes at 0 mA. Receives: Device: The Exopulse Mollii Suit on a Fibromyalgia patient |
| Suit group (G2) | Experimental | 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) Receives: Device: The Exopulse Mollii Suit on a Fibromyalgia patient |
| Suit + VR group (G3): | Experimental | 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. Receives: Device: The Exopulse Mollii Suit on a Fibromyalgia patient |
| Exercise group (G4): | Experimental | 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. Receives: Device: The Exopulse Mollii Suit on a Fibromyalgia patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
VAS (Visual analog scale)
Measured: 8 weeks
Postural stability
Baropodometric platform Namrol
Measured: 8 weeks
Heart rate variability
RS800CX monitor (Polar Inc., Kempele, Finland). The Kubios HRV software (v. 3.3)
Measured: 8 weeks
Tissue oxygenation
Oximeter. Moxy-3
Measured: 8 weeks
Thermographic distribution
Camera E85 24" LENS. TELEDYNE FLIR. FLIR E8-XT system
Measured: 8 weeks
Muscle activity
MDurance surface electromyography.
Measured: 8 weeks
Level of depression and anxiety
Depression Anxiety Stress Scale
Measured: 8 weeks
Body composition
Inbody 270
Measured: 8 weeks
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
Measured: 8 weeks
Cortical arousal
Measured trough the Critical Flicker Fusion Threshold (CFFT) in a viewing chamber (Lafayette Instrument Flicker Fusion Control Unit Model 12021)
Measured: 8 weeks
Functional test
chair stand test
Measured: 8 weeks
Functional test
Handgrip strength test
Measured: 8 weeks
Functional test
10m up and go test
Measured: 8 weeks
Functional test
One leg balance
Measured: 8 weeks
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)
Measured: 8 weeks
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start20 Dec 2022
- Primary completion19 Jan 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Caña Pino, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726123
- Sponsor's protocol ID
- 28922
- Status last verified
- Nov 2023
- First submitted
- 19 Jan 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Functional Effects of Therapeutic Intervention With Neuromodulation Suit With and Without Combination of Reverse Virtual Reality in Fibromyalgia Patients.
- ClinicalTrials.gov ID
- NCT05726123
- Acronym / sponsor ID
- 28922
- Conditions
- Fibromyalgia
- Keywords
- neuromodulation, fibromyalgia, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group (G1) | Placebo comparator | Device: The Exopulse Mollii Suit on a Fibromyalgia patientControl group (G1): in which the suit shall be switched on, but with the current of all electrodes at 0 mA. |
| Suit group (G2) | Experimental | Device: The Exopulse Mollii Suit on a Fibromyalgia patientSuit 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): | Experimental | Device: The Exopulse Mollii Suit on a Fibromyalgia patientSuit + 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 (G4): | Experimental | Device: The Exopulse Mollii Suit on a Fibromyalgia patientExercise 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Exopulse Mollii Suit on a Fibromyalgia patientAlso: a treatment session with the Exopulse Mollii Suit combined with VR on a Fibromyalgia patient, a training session have on a Fibromyalgia patientThe 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. | Device | Control group (G1), Exercise group (G4):, Suit + VR group (G3):, Suit group (G2) |
Primary outcome
Pain intensity
Time frame: 8 weeks
VAS (Visual analog scale)
Postural stability
Time frame: 8 weeks
Baropodometric platform Namrol
Heart rate variability
Time frame: 8 weeks
RS800CX monitor (Polar Inc., Kempele, Finland). The Kubios HRV software (v. 3.3)
Tissue oxygenation
Time frame: 8 weeks
Oximeter. Moxy-3
Thermographic distribution
Time frame: 8 weeks
Camera E85 24" LENS. TELEDYNE FLIR. FLIR E8-XT system
Muscle activity
Time frame: 8 weeks
MDurance surface electromyography.
Level of depression and anxiety
Time frame: 8 weeks
Depression Anxiety Stress Scale
Body composition
Time frame: 8 weeks
Inbody 270
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
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)
Functional test
Time frame: 8 weeks
chair stand test
Functional test
Time frame: 8 weeks
Handgrip strength test
Functional test
Time frame: 8 weeks
10m up and go test
Functional test
Time frame: 8 weeks
One leg balance
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Exopulse Mollii Suit on a Fibromyalgia patient in people with Fibromyalgia, run by University of Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 8 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.