Effects of Immersive Virtual Reality in Fibromyalgia

NCT ID: NCT06658223

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-02
• Study Completion Date: 2025-02-28

Brief 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. 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?

Conditions

Fibromyalgia (FM)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise with virtual reality

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.

Group Type: EXPERIMENTAL

Exercise with virtual reality

Intervention Type: OTHER

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.

Interventions

Exercise with virtual reality

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Males and females
• over 18 years of age
• with a diagnosis of fibromyalgia issued by a medical professional under the ACR criteria (2016)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad San Sebastián

OTHER

Sponsor Role: lead

Responsible Party

gonzalo arias alvarez

Mrs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

GONZALO J ARIAS-ALVAREZ

Role: PRINCIPAL_INVESTIGATOR

Universidad San Sebastián

Locations

Universidad San Sebastián

Concepción, Bio-bio, Chile

Countries

Chile

Other Identifiers

3

Identifier Type: -

Identifier Source: org_study_id