Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06658223

Effects of Immersive Virtual Reality 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?

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Fibromyalgia (FM) Behavior Fibromyalgia Motor Activity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad San Sebastián

Concepción, Biobio, 4080871, Chile

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise with Virtual reality

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Cortisol

    Time frame: SIX WEEKS

    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.

  2. Stress, anxiety and depression

    Time frame: SIX WEEKS

    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.

  3. Cognitive function

    Time frame: SIX WEEKS

    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.

Sponsors and collaborators

Lead sponsor

Universidad San Sebastián

Other

Registry information

Official study title

Effects of Immersive Virtual Reality on Quality of Life, Stress, Anxiety, Depression and Cortisol in Fibromyalgia

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.