Fibromyalgia (FM)NCT06658223
Effects of Immersive Virtual Reality in Fibromyalgia
A study testing Exercise with virtual reality in people with Fibromyalgia (FM), run by Universidad San Sebastián at 1 site in Chile.
Trial summary
Fibromyalgia is considered a disease of unknown etiology, which It affects between 2 to 5% of the population in developed countries, mostly women, diagnosed mainly between 40 and 50 years of age, and whose main characteristic is generalized presence of musculoskeletal pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia (FM)
- What is being tested?
- Exercise with virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 2 Sep 2024to 28 Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females
- over 18 years of age
- with a diagnosis of fibromyalgia issued by a medical professional under the ACR criteria (2016)
Who cannot join
- Subjects were excluded from the study when they presented pregnancy or lactation
- oncologic pain
- uncontrolled metabolic disorder
- vertigo or similar condition or any cognitive impairment that hinders the understanding of the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Immersive Virtual Reality on Quality of Life, Stress, Anxiety, Depression and Cortisol in Fibromyalgia
Fibromyalgia is considered a disease of unknown etiology, which It affects between 2 to 5% of the population in developed countries, mostly women, diagnosed mainly between 40 and 50 years of age, and whose main characteristic is generalized presence of musculoskeletal pain. Although the most described symptoms are multiple sensitive areas in trigger points, fatigue and cognitive dysfunction, this syndrome is associated commonly to anxiety disorders, depression and catastrophizing. In Chile, consultations specific cases of rheumatology due to Fibromyalgia reach 26.7%, with a similar reality in the commune of Concepción, as a result of which the need arises to implement a strategy different and innovative, in which an environment can be generated in which the user practices motor and cognitive strategies in different contexts, whether work or home, to through virtual reality, which has proven to be a promising tool in this group of the population, since by entering a controlled virtual environment, different techniques, taking them out of the conventional treatment box. In this way, it may include relaxation exercises, cognitive behavioral therapy, and physical activities adapted. This interaction may improve cognitive function, reduce anxiety symptoms, reduce painful perception associated with your health condition and improve your quality of life. Although there is knowledge and favorable experiences in its use, there is little information about the effects and the scope that it can have in patients with fibromyalgia. For this reason, it is proposed to carry out an investigation applying a Kinesiological treatment complemented with virtual reality. in patients with this disease. Therefore, the research question arises: What is the effectiveness of a kinesiological treatment, complemented with immersive virtual reality, on quality of life, cognitive and psychoemotional function in patients with fibromyalgia?
Read the detailed description
According to the World Health Organization (WHO), fibromyalgia is considered a disease of unknown etiology, which affects between 2 and 5% of the population of developed countries, mostly women, diagnosed mainly between the ages of 40 and 50. In Chile, the prevalence is in a range between 1 and 2%. This disease is characterized by persistent generalized musculoskeletal pain, emotional symptoms such as anxiety, depression and cognitive disorders that mainly affect concentration and memory and compromise their quality of life.
It is for this reason that the need arises to implement a different, innovative strategy, in which an environment can be generated in which the patient can put motor and cognitive strategies into practice in different contexts, whether work or home, through virtual reality.
Virtual reality has proven to be a promising tool in the treatment of fibromyalgia. When patients enter a controlled virtual environment, they can work on different techniques that avoid conventional treatment pigeonholing. Current evidence describes the effectiveness of virtual reality in chronic pain syndromes, rheumatoid arthritis and especially in central neurological injuries, incorporating relaxation exercises and adapted physical activities. This interaction can improve cognitive function and reduce symptoms of anxiety and depression associated with their health condition. Although there is favorable knowledge and experiences in its use, there is little information about the effects and scope that it can have in patients with fibromyalgia, which is why it is proposed to carry out research applying a Kinesiological treatment complemented with virtual reality in patients with this disease. Therefore, the research question arises: What is the effectiveness of a kinesiological treatment, complemented with immersive virtual reality, on quality of life, cognitive and psychoemotional function in patients with fibromyalgia?
- Conditions
- Fibromyalgia (FM)
- Being tested
- Exercise with virtual reality
- Keywords
- FIBROMYALGIA, VIRTUAL REALITY, EXERGAME, EXERCISE
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with virtual realityOther
The virtual reality program consisted of twelve sessions (2 per week for six weeks) of 10 min warm-up plus 15 minutes of exercise with the FitXR game (developed by FITAR LIMITED) on the Oculus Quest 2™ device. The warm-up consisted of moderate-intensity aerobic exercise on a cycle ergometer. The BORG CR-10 perceived exertion scale was used to determine this intensity. Subsequently, they continued with the FitXR game, starting with a 5-minute phase of muscular activation and global movements of their limbs. They performed eye-hand coordination exercises, hitting balls that came to the person at different speeds, and ended with muscle stretching and slow breathing. These exercises presented different difficulty levels and were adjusted to the person's condition. In the same way, as the game developed, it was possible to increase the level and thus increase its complexity.
| Study group | Role | What they receive |
|---|---|---|
| Exercise with virtual reality | Experimental | The virtual reality program consisted of twelve sessions (2 per week for six weeks) of 10 min warm-up plus 15 minutes of exercise with the FitXR game (developed by FITAR LIMITED) on the Oculus Quest 2™ device. The warm-up consisted of moderate-intensity aerobic exercise on a cycle ergometer. The BORG CR-10 perceived exertion scale was used to determine this intensity. Subsequently, they continued with the FitXR game, starting with a 5-minute phase of muscular activation and global movements of their limbs. They performed eye-hand coordination exercises, hitting balls that came to the person at different speeds, and ended with muscle stretching and slow breathing. These exercises presented different difficulty levels and were adjusted to the person's condition. In the same way, as the game developed, it was possible to increase the level and thus increase its complexity. Receives: Other: Exercise with virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Fibromyalgia on Quality of Life
The Impact of Fibromyalgia on Quality of Life was assessed using the FIQ-R instrument. This self-administered test measures difficulty in activities of daily living in the last week, the overall influence of the disease in the last week, and the severity of symptoms in the past week. Total scores range from 0 to 100, with higher scores indicating more severe symptoms and disability.
Measured: SIX WEEKS
Secondary outcomes (3)
Cortisol
Cortisol levels will be measured using the Cortisol ELISA saliva kit from the manufacturer IBL International Gmbh ®. Prior to the experiment, subjects will be asked not to consume solid or liquid food 60 minutes before the test, as recommended by the manufacturer. The sample collection procedure will be carried out according to the manufacturer's guidelines. They will then be stored at -20°C until the respective analysis is carried out. The sample will be kept away from heat and direct sunlight. The entire procedure will be carried out in the laboratories of the Medical Technology Department of the Universidad San Sebastián, Concepción campus.
Measured: SIX WEEKS
Stress, anxiety and depression
Stress, anxiety, and depression were assessed using the Depression Anxiety Stress Scale-21 (DASS-21). This self-administered dimensional test consists of twenty-one questions to evaluate three categories, specifically stress, anxiety, and depression. It presents four response options for each category, evaluated on a scale from 0 to 3. The score obtained for each category is multiplied by 2, and the result is classified as normal, mild, moderate, severe, and extremely severe.
Measured: SIX WEEKS
Cognitive function
Cognitive function in both groups will be assessed by applying the MoCA questionnaire, a brief cognitive assessment test that measures the performance of abilities such as memory, orientation, language, concentration, executive function and visuospatial skills.
Measured: SIX WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start2 Sep 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia (FM)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal quasi-experimental study. The application of the study protocol will be carried out, in its entirety, at the kinesiology center of the Universidad San Sebastián, Concepción campus.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad San Sebastián
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gonzalo arias alvarez, Universidad San Sebastián
- Investigators
- GONZALO J ARIAS-ALVAREZ, Principal investigator, Universidad San Sebastián
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658223
- Sponsor's protocol ID
- 3
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: WE ARE NOT SURE ABOUT IT, BUT WE DO NOT REFUSE TO GRANT IT LATER ON.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Immersive Virtual Reality on Quality of Life, Stress, Anxiety, Depression and Cortisol in Fibromyalgia
- ClinicalTrials.gov ID
- NCT06658223
- Acronym / sponsor ID
- 3
- Conditions
- Fibromyalgia (FM)
- Keywords
- FIBROMYALGIA, VIRTUAL REALITY, EXERGAME, EXERCISE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad San SebastiánUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 26 Oct 2024 (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.
Fibromyalgia is considered a disease of unknown etiology, which It affects between 2 to 5% of the population in developed countries, mostly women, diagnosed mainly between 40 and 50 years of age, and whose main characteristic is generalized presence of musculoskeletal pain. Although the most described symptoms are multiple sensitive areas in trigger points, fatigue and cognitive dysfunction, this syndrome is associated commonly to anxiety disorders, depression and catastrophizing. In Chile, consultations specific cases of rheumatology due to Fibromyalgia reach 26.7%, with a similar reality in the commune of Concepción, as a result of which the need arises to implement a strategy different and innovative, in which an environment can be generated in which the user practices motor and cognitive strategies in different contexts, whether work or home, to through virtual reality, which has proven to be a promising tool in this group of the population, since by entering a controlled virtual environment, different techniques, taking them out of the conventional treatment box. In this way, it may include relaxation exercises, cognitive behavioral therapy, and physical activities adapted. This interaction may improve cognitive function, reduce anxiety symptoms, reduce painful perception associated with your health condition and improve your quality of life. Although there is knowledge and favorable experiences in its use, there is little information about the effects and the scope that it can have in patients with fibromyalgia. For this reason, it is proposed to carry out an investigation applying a Kinesiological treatment complemented with virtual reality. in patients with this disease. Therefore, the research question arises: What is the effectiveness of a kinesiological treatment, complemented with immersive virtual reality, on quality of life, cognitive and psychoemotional function in patients with fibromyalgia?
Detailed description
According to the World Health Organization (WHO), fibromyalgia is considered a disease of unknown etiology, which affects between 2 and 5% of the population of developed countries, mostly women, diagnosed mainly between the ages of 40 and 50. In Chile, the prevalence is in a range between 1 and 2%. This disease is characterized by persistent generalized musculoskeletal pain, emotional symptoms such as anxiety, depression and cognitive disorders that mainly affect concentration and memory and compromise their quality of life.
It is for this reason that the need arises to implement a different, innovative strategy, in which an environment can be generated in which the patient can put motor and cognitive strategies into practice in different contexts, whether work or home, through virtual reality.
Virtual reality has proven to be a promising tool in the treatment of fibromyalgia. When patients enter a controlled virtual environment, they can work on different techniques that avoid conventional treatment pigeonholing. Current evidence describes the effectiveness of virtual reality in chronic pain syndromes, rheumatoid arthritis and especially in central neurological injuries, incorporating relaxation exercises and adapted physical activities. This interaction can improve cognitive function and reduce symptoms of anxiety and depression associated with their health condition. Although there is favorable knowledge and experiences in its use, there is little information about the effects and scope that it can have in patients with fibromyalgia, which is why it is proposed to carry out research applying a Kinesiological treatment complemented with virtual reality in patients with this disease. Therefore, the research question arises: What is the effectiveness of a kinesiological treatment, complemented with immersive virtual reality, on quality of life, cognitive and psychoemotional function in patients with fibromyalgia?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal quasi-experimental study. The application of the study protocol will be carried out, in its entirety, at the kinesiology center of the Universidad San Sebastián, Concepción campus.
| Arm | Type | Receives |
|---|---|---|
| Exercise with virtual reality | Experimental | Other: Exercise with virtual realityThe virtual reality program consisted of twelve sessions (2 per week for six weeks) of 10 min warm-up plus 15 minutes of exercise with the FitXR game (developed by FITAR LIMITED) on the Oculus Quest 2™ device. The warm-up consisted of moderate-intensity aerobic exercise on a cycle ergometer. The BORG CR-10 perceived exertion scale was used to determine this intensity. Subsequently, they continued with the FitXR game, starting with a 5-minute phase of muscular activation and global movements of their limbs. They performed eye-hand coordination exercises, hitting balls that came to the person at different speeds, and ended with muscle stretching and slow breathing. These exercises presented different difficulty levels and were adjusted to the person's condition. In the same way, as the game developed, it was possible to increase the level and thus increase its complexity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females
- over 18 years of age
- with a diagnosis of fibromyalgia issued by a medical professional under the ACR criteria (2016)
Key exclusion criteria (4 listed)
- Subjects were excluded from the study when they presented pregnancy or lactation
- oncologic pain
- uncontrolled metabolic disorder
- vertigo or similar condition or any cognitive impairment that hinders the understanding of the informed consent.
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 |
|---|---|---|
| Exercise with virtual realityThe virtual reality program consisted of twelve sessions (2 per week for six weeks) of 10 min warm-up plus 15 minutes of exercise with the FitXR game (developed by FITAR LIMITED) on the Oculus Quest 2™ device. The warm-up consisted of moderate-intensity aerobic exercise on a cycle ergometer. The BORG CR-10 perceived exertion scale was used to determine this intensity. Subsequently, they continued with the FitXR game, starting with a 5-minute phase of muscular activation and global movements of their limbs. They performed eye-hand coordination exercises, hitting balls that came to the person at different speeds, and ended with muscle stretching and slow breathing. These exercises presented different difficulty levels and were adjusted to the person's condition. In the same way, as the game developed, it was possible to increase the level and thus increase its complexity. | Other | Exercise with virtual reality |
Primary outcome
Impact of Fibromyalgia on Quality of Life
Time frame: SIX WEEKS
The Impact of Fibromyalgia on Quality of Life was assessed using the FIQ-R instrument. This self-administered test measures difficulty in activities of daily living in the last week, the overall influence of the disease in the last week, and the severity of symptoms in the past week. Total scores range from 0 to 100, with higher scores indicating more severe symptoms and disability.
3 secondary outcomes
Cortisol
Time frame: SIX WEEKS
Stress, anxiety and depression
Time frame: SIX WEEKS
Cognitive function
Time frame: SIX WEEKS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: Undecided. WE ARE NOT SURE ABOUT IT, BUT WE DO NOT REFUSE TO GRANT IT LATER ON.
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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.
GONZALO J ARIAS-ALVAREZ principal investigator
Universidad San Sebastián
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with virtual reality in people with Fibromyalgia (FM), run by Universidad San Sebastián at 1 site in Chile.
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 4 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: status not confirmed, as of the sponsor's last update on 26 Oct 2024. 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 Chile. 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. 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?
Results are not available in the source record.
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?
Impact of Fibromyalgia on Quality of Life (time frame: SIX WEEKS). 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 26 Oct 2024.