Circadian Variation of Blood Pressure in Patients With Fibromyalgia After a Whole Body Photobiomodulation Treatment: a Triple-blinded Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of Diurnal/nocturnal blood pressure ratio perceived at three months
研究概览
简要总结
Fibromyalgia syndrome (FMS) is a chronic and multicomponent illness with unknown etiology and is considered the most frequent cause of diffuse chronic musculoskeletal pain. There is little evidence to confirm if the condition is fully improved after a specific treatment program. Thus a multifactorial understanding of the pathology is crucial to propose new alternative treatments. In this regard, an alteration in circadian blood pressure and persistent nocturnal sympathetic hyperactivity have been shown in patients suffering from fibromyalgia syndrome, leading to malfunctioning in the autonomic nervous system. This is a common pathogenesis shared also by patients with non-dipping blood pressure pattern, which has been closely associated with cardiovascular morbidity. Finally, a significant relationship between fibromyalgia syndrome and non-dipping blood pressure pattern has been shown. Therefore, alterations in circadian blood pressure appear as an additional risk factor in patients with fibromyalgia syndrome, and treatments focus on recovering such blood pressure pattern may be indicated.
详细描述
Studying variations of blood pressure is a way of assessing the master circadian clock, through the diurnal/nocturnal BP ratio.
When alteration of the circadian rhythm appears, neurohumoral factors that affect autonomic nervous and cardiovascular systems are affected, which presents persistent changes in the blood pressure pattern. These alterations caused by a disturbed circadian rhythm could contribute to the pathogenesis of chronic disorders in general and especially to fibromyalgia syndrome.
The aim of the study is to analyze changes in blood pressure and central sensitisation (pain pressure threshold) after a whole-body photobiomodulation treatment in patients suffering from fibromyalgia syndrome, as well as in pain, quality of life and autonomic symptoms. Furthermore, to study the level of association between blood pressure changes and pain perception, quality of life and autonomic symptoms after the end of the treatment. Finally, to study the effects of the treatment 3 months after the end of the treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed from FM presenting generalized pain in at least four or five regions.
- •Present symptoms for at least 3 months at similar levels.
排除标准
- •Inflammatory, neurological, or orthopedic disease which can alter balance, hearing, and vision, and cognitive impairment in terms of the ability to answer questions.
结局指标
主要结局
Change of Diurnal/nocturnal blood pressure ratio perceived at three months
时间窗: time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment)
The diurnal/nocturnal blood pressure ratio is defined as the nocturnal decline in BP relative to the diurnal blood pressure mean, and it is calculated as 100×(mean diurnal blood pressure-mean nocturnal blood pressure)/mean diurnal blood pressure. Mean blood pressure is calculated by mean blood pressure = diastolic pressure + 1/3 (systolic pressure - diastolic pressure). There are four possible groups: extreme-dippers (diurnal/nocturnal BP ratio ≥20%), normal dippers (ratio ≥10%), non-dippers (ratio \<10%), and inverse-dippers or risers (ratio \<0%, indicating nocturnal BP above the diurnal mean).
次要结局
- Change from autonomic nervous system activity at 3 months(time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment))
- Change from baseline Pain pressure threshold at 3 months(time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment))
- Change from elastography at 3 months(time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment))
- Change from baseline perceived pain at 3 months(time (t) 1(prior to treatment), t2 (immediately after treatment ), t3 (3 months after completion of treatment))
研究者
SANTIAGO NAVARRO LEDESMA
UNIVERSITY PROFESSOR
University of Malaga