Clinical trial NCT05726123: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: neuromodulation
fibromyalgia
virtual reality
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Pain intensity
timeFrame: 8 weeks
measure: Postural stability
timeFrame: 8 weeks
measure: Heart rate variability
timeFrame: 8 weeks
measure: Tissue oxygenation
timeFrame: 8 weeks
measure: Thermographic distribution
timeFrame: 8 weeks
measure: Muscle activity
timeFrame: 8 weeks
measure: Level of depression and anxiety
timeFrame: 8 weeks
measure: Body composition
timeFrame: 8 weeks
measure: Respiratory variables (forced expiratory volume in 1 second (FEV1), 6 seconds (FEV6) and the ratio of both these values (FEV1/FEV6))
timeFrame: 8 weeks
measure: Cortical arousal
timeFrame: 8 weeks
measure: Functional test
timeFrame: 8 weeks
measure: Functional test
timeFrame: 8 weeks
measure: Functional test
timeFrame: 8 weeks
measure: Functional test
timeFrame: 8 weeks
measure: Pressure pain threshold
timeFrame: 8 weeks
measure: Salivary Biomarkers
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Alejandro Rubio Zarapuz
Study officials:
References: