The Effect of Perception of Improvement Provided Virtual Reality Environment on Symptom Presence and Severity in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Functional Magnetic Resonance
研究概览
简要总结
Fibromyalgia (FM) is a chronic pain syndrome characterized by impaired perception, transmission, and processing of nociceptive stimuli and causing widespread pain. Pain in FM is the disease itself and is characterized by nociplastic pain that may occur independently of any peripheral nociceptor activity or be felt without disease or damage to the somatosensory system. It is thought that the pain processing process is disrupted due to the changing neurotransmitter release activity and this situation causes pain to be felt more in FM. Chronic pain is the result of perception alteration associated with nociceptive afferent information affecting the cortex; underlying this change are limbic emotional learning mechanisms. Numerous factors, including emotional state, attention, and past painful experiences, modulate nociceptive inputs with the activation of multiple brain regions, resulting in a personalized pain experience. The chronic pain management program should target the central nervous system rather than the peripheral tissues because pain originates in the sensitized nervous system. For this reason, it is important to include plasticity-oriented approaches, cortical disinhibition methods, and strategies for improving perception and behavior change, which aim to replace negative beliefs with positive beliefs, into clinical practice. Our project aims to investigate the effectiveness of the therapeutic intervention, which consists of patient education supported Neuro-Linguistic Programming (NLP), visual feedback and metaphor-assisted breathing therapy designed to provide a perception of improvement and presented in a virtual reality environment, on pain processing, pain intensity, pain-pressure threshold, psychosomatic reflections (biomechanical and viscoelastic properties of tissue, sleep quality, pain catastrophizing behavior, anxiety and depression), disease impact and quality of life in FM patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Fibromyalgia at least 1 year ago according to ACR criteria
- •Age range 25-55
- •Scored at least 24 on the Mini-Mental State Assessment Test
- •Reported weekly pain intensity of at least 40 mm on the Visual Analog Scale
- •Be on a stable dose of medication for at least 6 months (serotonin norepinephrine reuptake inhibitors [e.g., duloxetine, milnacipran]; alpha 2-delta receptor ligand [e.g., pregabalin]; gabapentinoids)
排除标准
- •Having inflammatory rheumatic disease, malignancy, neurological disease, connective tissue disease, severe anemia, uncontrolled endocrine diseases
- •Body Mass Index (BMI) ≥ 30 Kg/m2
- •Being pregnant
- •Having inability to understand, read and speak Turkish
- •Having difficulty in hearing and seeing
- •Having any metallic or electronic device in the body that will create incompatibility with the magnetic field in the fMRI scan Having any disease diagnosis (serious psychotic disorder, delirium, mental retardation, epilepsy, heart disease, lung diseases, etc.) that may prevent participation in the evaluation and training to be conducted within the scope of the research
结局指标
主要结局
Functional Magnetic Resonance
时间窗: Measurement of changes from baseline process of processing pain will be measured at 6 week and 10 week
The process of processing pain will be determined by functional magnetic resonance imaging performed immediately before and after the experimental pressure pain. ROI analysis will ve performed. No score is defined.
Measurement of pain-pressure threshold
时间窗: Measurement of changes from baseline of pain-pressure threshold will be measured at 6 week and 10 week
Pain-pressure threshold evaluated with a pain threshold measuring device (Algometer).
次要结局
- Sleep Quality(Measurement of changes from baseline of sleep quality will be measured at 6 week and 10 week)
- Functional status and disease impact(Measurement of changes from baseline of functional status and disease impact will be measured at 6 week and 10 week.)
- Quality of Life of patients(Measurement of changes from baseline of quality of life will be measured at 6 week and 10 week)
- Anxiety and Depression Status(Measurement of changes from baseline of anxiety and depression status will be measured at 6 week and 10 week)
- Pain catastrophizing behavior(Measurement of changes from baseline of changes from baseline of pain catastrophizing behaviors will be measured at 6 week and 10 week)
- Patient satisfaction(Measurement of changes from baseline of patient satisfaction will be measured at 6 week and 10 week)
- Measurement of biomechanical characteristics of tissue(Measurement of changes from baseline decrement values of tissue will be measured at 6 week and 10 week])
- Measurement of viscoelastic characteristics of tissue(Measurement of changes from baseline relaxation time values of tissue will be measured at 6 week and 10 week])
研究者
Nilufer Kablan
Assoc. prof
Istanbul Medeniyet University