Effects of Manual Therapy on Autonomic Nervous System's Balance, Pain and Well-being in Patients With Fibromyalgia.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Change in Heart rate variability
研究概览
简要总结
Scientific literature dealing with patients with fibromyalgia conveys they suffer from an abnormal response of the autonomic nervous sýstem, where a marked sympathetic hyperactivity and a decrease in heart rate variability are emphasized. It is important to know what manual therapy techniques may manage to decrease the sympathetic activity and balance the sympathetic-vagal tone, therefore improving pain and life quality.
This study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the Ryff scale) and pain in patients with fibromyalgia.
详细描述
Scientific literature dealing with patients with fibromyalgia conveys they suffer from an abnormal response of the autonomic nervous sýstem, where a marked sympathetic hyperactivity and a decrease in heart rate variability are emphasized. It is important to know what manual therapy techniques may manage to decrease the sympathetic activity and balance the sympathetic-vagal tone, therefore improving pain and life quality.
This study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the Ryff scale) and pain in patients with fibromyalgia.
The authors expect a stronger decrease in the sympathetic nervous system activation; a greater reduction in pain, and a bigger improvement in well-being and anxiety in those patients treated with active mobilization of soft tissues than passive mobilization group.
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 (Outcomes Assessor)
盲法说明
Patients will be divided randomly into 3 groups, using the website www.random.org.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatologic diagnosis of fibromyalgia, chronic fatigue labels, sleep disorders, recurrent cervical pain associated with fibromyalgia
排除标准
- •Smokers, blood pressure superior to 160/100 mm/Hg, coronary artery disease, peripheral vascular disease, presence of Diabetes I or II, being pregnant, psychiatric disorder established, any trauma suffered in the last 6 months, diagnosis of osteoarthritis, consumption of caffeine, alcohol or other stimulating substance at least 24 hours before the experimental intervention, performing moderate-intense physical activity 2 hours before the experimental intervention.
研究组 & 干预措施
Experimental group 1
Active mobilization of soft tissues
干预措施: Active mobilization of soft tissues (Other)
Experimental group 2
Passive mobilization
干预措施: Passive mobilization (Other)
Control group
No intervention
结局指标
主要结局
Change in Heart rate variability
时间窗: 10 minutes (before, during and after intervention)
Heart rate variability (HRV) will be assessed as an indicator of autonomic regulation. The HRV measurement will be made through the Elite HRV application, using the value of rMSSD.
次要结局
- Psychological well-being(1 week (just before intervention, 1 week after intervention))
- Pain assessed by the numerical rating scale (NRS)(10min (before and after intervention))