Physiological and Functional Effects of Therapeutic Intervention With Neuromodulation Suit With and Without Combination of Reverse Virtual Reality in Fibromyalgia Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postural stability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Having received physiotherapy 4 weeks prior to data collection.
- •Personal Psychological Apprehension Scale (PPAS) score greater than 37.
- •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.
结局指标
主要结局
Postural stability
时间窗: 8 weeks
Baropodometric platform Namrol
Pain intensity
时间窗: 8 weeks
VAS (Visual analog scale)
Heart rate variability
时间窗: 8 weeks
RS800CX monitor (Polar Inc., Kempele, Finland). The Kubios HRV software (v. 3.3)
Tissue oxygenation
时间窗: 8 weeks
Oximeter. Moxy-3
Thermographic distribution
时间窗: 8 weeks
Camera E85 24" LENS. TELEDYNE FLIR. FLIR E8-XT system
Muscle activity
时间窗: 8 weeks
MDurance surface electromyography.
Level of depression and anxiety
时间窗: 8 weeks
Depression Anxiety Stress Scale
Body composition
时间窗: 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))
时间窗: 8 weeks
To measure the following variables a spirometry test was conducted with a Vitalograph Asma1 spirometer
Cortical arousal
时间窗: 8 weeks
Measured trough the Critical Flicker Fusion Threshold (CFFT) in a viewing chamber (Lafayette Instrument Flicker Fusion Control Unit Model 12021)
Pressure pain threshold
时间窗: 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
时间窗: 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
Functional test
时间窗: 8 weeks
chair stand test
次要结局
未报告次要终点
研究者
Alejandro Caña Pino
Clinical Proffesor
University of Extremadura