Study of the Effect of a Postural Exercise Program in Women With Fibromyalgia: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Proprioception
研究概览
简要总结
In the current study, the investigators aimed to study:
- The proprioception status of patients with FMS.
- The effectiveness of a postural exercise program in women with fibromyalgia for 8 weeks (2 sessions per week), compared to a low impact aerobic exercise program on different parameters, such as proprioception, balance, muscle strength, flexibility and joint range.
详细描述
Fibromyalgia syndrome (FMS) is a multisystemic disease, characterized by generalized chronic musculoskeletal pain. In addition, it is usually accompanied by fatigue, sleep disorders, morning stiffness, cognitive disorders, depression, anxiety and stress. Other common symptoms are back pain, headaches, irritable bowel, balance problems and deterioration of physical function.
It constitutes the second most common rheumatic 36 disorder after osteoarthritis, with a prevalence of 2.9% in Europe and a fivefold times greater incidence among women than men.
Patients with FMS have pain at specific pressure points known as "tender points", with increased sensitivity to painful stimuli (hyperalgesia) and a decreased pain threshold (allodynia), in the absence of abnormalities in the biological or imaging tests. These tender points constitute the basis of the most sensitive and specific criteria for the diagnosis of the disease, this is, the criteria of the American College of Rheumatology. Accordingly, women presenting at least 11 of 18 tender points are diagnosed with FMS.
The etiology of FMS remains unclear. However, the generalized hyperalgesia, widespread pain and spontaneous pain in FMS have been related to central changes, and many studies support a major role for central sensitization in the generation of the symptoms of FMS.
Since it is a chronic disease, the care of this type of patients represents a significant economic burden. They have great health care resource requirements in both direct medical care and indirect costs of staff absenteeism. For these reasons, it is considered a major problem with a great impact on the health system, and therefore more and more studies are being developed with the aim of better understanding the pathophysiology of this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged between 30 and 65 years.
- •Meeting ACR 2010 criteria for FMS.
排除标准
- •Medical contraindication for physical activity.
- •Deafness or limited hearing.
- •Vestibular disorders that compromise balance.
- •Low vision or blindness.
- •Psychotic disorder or cognitive impairment.
- •Decompensation or changes in medication.
- •Surgical interventions in the last six months.
- •Rheumatic disease.
结局指标
主要结局
Proprioception
时间窗: 8 weeks
Proprioception will be evaluated at baseline and at the end of the study possible differences between women with fibromyalgia and healthy women using an isokinetic device (BIODEX MULTI-JOINT SYSTEM - PRO). The following movements were analized: knee (flexion, extension), hip (flexion, extension, abduction, adduction), ankle (flexion, extension), shoulder (flexion, extension). Joint position sense for knee extension and shoulder flexion will be also performed.
次要结局
- Handgrip strength(8 weeks)
- Impact on quality of life(8 weeks)
- Pain(8 weeks)
- Fatigue(8 weeks)
- Joint range of motion(8 weeks)
- Balance(8 weeks)
- Leisure Time Physical Activity(8 weeks)
- Anxiety and Depression(8 weeks)
- Sleep disorders(8 weeks)
研究者
Marta Inglés de la Torre
Principal investigator
University of Valencia
