Biofeedback Training, Efficacy Evaluation of Fibromyalgia Treatment, a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Sense of Coherence Scale 13- item (SOC), change is being assessed
研究概览
简要总结
Biofeedback equipment is classified by the Food and Drug Administration (FDA) as medical device class II and this type of equipment/treatment has shown evidence regarding stress management.
In fibromyalgia. The main objective of the study is to verify the feasibility of an HVR biofeedback training protocol in patients with fibromyalgia, and also to verify improvement induced by the technique in relation to: Quality of life; Quality of sleep; Perception of pain; Depressive symptomatology; Anxious symptomatology.
详细描述
Background and rationale of study
Fibromyalgia (FM) is a chronic disease, it is characterised by persistent and diffused musculoskeletal pain with not well defined etiology. Fibromyalgia often occurs in comorbidity with other functional, organic and psychiatric pathologies. The main clinical manifestation of FM is pain, which is predominantly described by people with fibromyalgia as a burning sensation, stiffness, contracture and tension. Pain varies depending on moments of the day, activity levels, weather conditions, sleep cycle and perceived distress. Patients suffering from fibromyalgia commonly have functional disorders, including persistent fatigue,dysregulated sleep, cognitive slowness, bowel disorders, paresthesia. Futhermore, fibromyalgia occurs in comorbidity with depression with a percentage that varies between 22% and 80% (3,4). Moreover, some patients with fibromyalgia have anxiety disorder and other syndromes related to stress as irritable bowel. The prevalence of fibromyalgia in general population is 2%, with a peak of onset between 45-60 years. The gender prevalence varies between 0.5% and 5%, it is more common between women (~ 4.2%) than men (~0.2%).
Fibromyalgia has an important impact on the quality of life. Biofeedback is one of the medical devices used for the treatment of fibromyalgia, that aimes to riduce the typical symptoms and improve QoL.
Biofeedback allows to learn self-regulation of some physiological processes through feedback of recorded parameters and the goal is improving health and its performances.
Biofeedback measures muscle activity, skin temperature, electrodermal activity (sudoriparous glands activity), respiration, heart rate, blood pressure, electrical brain activity and bloodstream, it also gives a quick feedback of those personal measurements to the patient, in this way biofeedback teaches people to have a more active role in maintaining a good personal, mental and physical health (quickly and thoroughly it give person feedback of activity and biofeedback teaches people to take a more active role in maintaining personal health and mental health and physical health).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosed with fibromyalgia afferent to the clinic of pain therapy of San Giovanni hospital in Cagliari, Sardegna. Psychiatric comorbidities have no exclusion criterion
排除标准
- •Patients with cognitive difficulties and/or diagnoses of mental retardation and male patients will not be included in the study. Male patients will be excluded because the diagnosy of FM is infrequent in male patients and it was decided not to have bias because of the low amount of patients included in the study
结局指标
主要结局
Sense of Coherence Scale 13- item (SOC), change is being assessed
时间窗: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
Self-administered questionnaire consisting of 13 items providing a total score and a score for each dimension: "comprehensibility" (C), which refers to the ability to perceive life events as coherent, structured and clear; "Manageability" (Ma), which refers to the ability to perceive that the available resources satisfy the needs of life; and "Significance" (Me), which refers to the feeling that life, emotionally, makes sense. The total score ranges from 13 to 91, with higher scores indicating a higher SOC.
Quality of sleep, Sleep scale from the medical study (MOS),change is being assessed
时间窗: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
Self-assessment questionnaire consisting of 12 items and is aimed at evaluating certain fundamental parameters in sleep disorders such as sleep, sleep continuity, sleep duration, sleepiness and breathing disorders during sleep. The total score is on the scale ranges from 0 to 100. Higher scores indicate more disturbed sleep
Patient Health Questionnaire-9 (PHQ-9), change is being assessed
时间窗: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
Short self-administered tool used for screening, diagnosis, monitoring and measuring the severity of depression. It's composed of 9 items that correspond to the symptoms of major depression according to DSM-IV. The score has a range between 0 and 27. Scores between 0 and 9 indicate the presence of a sub-threshold depression. The score of 10 is indicated as the point at which the sensitivity and specificity of the instrument are recognized as optimal for highlighting depressions of clinical relevance.
Fibromyalgia Impact Questionnaire (FIQ), change is being assessed
时间窗: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
self-administered questionnaire, consisting of 20 questions, divided into three parts: ability to carry out activities of daily life; number of days in the last week in which the patient has felt good and in which he has not been able to carry out his work due to the symptoms of FM. Questions 4 to 10 relate to the extent of FM interference with one's work, the intensity of pain and fatigue, the quality of the night's rest, the intensity of stiffness and the presence of anxiety or depression; responses range from 0 (no disturbance) to 10 (very important disorder), marked on a horizontal linear scale. The maximum FIQ score, corresponding to the highest degree of disability, is 100
Bodily and emotional perception of pain (BEEP), change is being assessed
时间窗: T0 (0 weeks); T1 (10 weeks); T2 (22 weeks); T3 (34 weeks)
Instrument consisting of 23 items with Likert scale with six-step interval (from 0 to 5), organized in three subscales definable according to the following denomination: Emotional reaction induced by pain (including 15 items); Limitations caused by pain in the daily life (including 4 items); and Interference of pain on mood, interpersonal relationships, sleep and pleasure of living (4 items).
次要结局
未报告次要终点
研究者
Mauro Giovanni Carta
Principal Investigator
University of Cagliari