Comparison of the Efficacy of Electromyographic Biofeedback, Aerobic Exercise (Biodanza) and Stretching in Patients With Fibromyalgia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 主要终点
- Change from baseline Fibromyalgia Impact Questionnaire (FIQ) at 3 months.
研究概览
简要总结
Some authors claim that patients with musculoskeletal pain tend to underestimate their levels of muscle tension. The results of studies find evidences of the deficits in the perception of muscular tension in patients with chronic pain, being this the pathogenic factor in some musculoskeletal alterations. These studies show that patients with chronic pain can not identify their muscle tension and suggest that this contributes to maintaining pain. Thus, positive results have been found with relaxation and electromyographic biofeedback in patients with chronic pain. If these symptoms are due to excessive stress, patients should be able to benefit from regulation of muscle activity through BFB-EMG, thus learning to regulate the physiological variable. The study will be carried out in the electrotherapy laboratory of the Health Sciences Building of the University of Almeria. Initially, the sample will be chosen and the informed consent of the subjects will be obtained. Before the start of treatment, a baseline assessment of the dependent variables will be performed. Subsequently subjects will undergo three sessions of manipulative therapy over 12 weeks (one session per week). After the therapeutic intervention, a new determination of the dependent variables will be performed.
详细描述
Fibromyalgia (FM) affects nearly 2.4% of the Spanish population, mostly women aged between 40 and 60. This disease, which is characterized by a disturbance in their pain regulation with an increased sensitivity to painful stimuli and a decrease of pain threshold, has a strong impact on the patients' health and their quality of life, restricting the realization of their daily activities. Moreover, it presents a high prevalence of comorbidities, which increases the needs of these patients in terms of effective therapeutic management leading to higher health requirements.
In addition to that, FM response to drug treatments is low and its symptoms become more frequent simultaneously with adverse effects, and according to that, an individualized analysis becomes necessary as well as a multidisciplinary approach, since there is no absolute treatment up to now.
This study aims to compare the improvements obtained in the quality of life, pain and other FM symptoms respectively, by means of applying physical therapies (such as aerobic biodance exercise in aquatic environment and stretching exercises) and psychological treatments, such as electromyographic biofeedback (BFB-EMGS) based training.
Objectives:
To comparatively analyze the level of improvement that can be reached by FM patients, by means of pool exercises based treatments, stretching exercises and BFB-EMGS therapies.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 72 years and diagnosed with FMS according to 2010 ACR criteria. Before being included in the study, all the subjects must have signed an informed consent to ensure their participation, stating that it may be left at any time if were necessary.
排除标准
- •Patients with physical or mental illness, infections, fever, hypotension, respiratory disorders which prevent the treatment realization, patients who do not maintain usual treatment during the study period or who do not perform the full intervention.
结局指标
主要结局
Change from baseline Fibromyalgia Impact Questionnaire (FIQ) at 3 months.
时间窗: At baseline and 12 weeks
This questionnaire was designed to evaluate the influence of FMS in the patients' daily life. A properly validated Spanish version of FIQ was applied in this study.
次要结局
- Pittsburgh Sleep Quality Index (PSQI).(At baseline and 12 weeks)
- State-Trait Anxiety Inventory (STAI).(At baseline and 12 weeks)
- McGill Questionnaire.(At baseline and 12 weeks)
- Pressure algometry.(At baseline and 12 weeks)
- Visual Analogical Scale (VAS).(At baseline and 12 weeks)
- Center for Epidemiological Studies Depression Scale.(At baseline and 12 weeks)
研究者
María del Mar Lopez-Rodriguez
Assistant Professor
Universidad de Almeria