Effectiveness of an Intervention Program With Electric Stimulation Therapy in Patients With Raynaud's Phenomenon: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Raynaud´s Phenomenon attacks
研究概览
简要总结
The purpose of this study is to analyze the effects of an intervention with galvanic electrical current on the number of attacks , temperature, pain, peripheral blow flow and upper limb functionality in patients with Raynaud's Phenomenon in comparison to a control group that will maintain their habitual treatment.
详细描述
Raynaud's Phenomenon is a disorder that causes pain and functional limitation in people who suffer it.
Investigators considerer that the application of an electrotherapy intervention with galvanic current, thanks to its vasodilator action, will produce clinically significant improvements in the number of attacks, temperature and blood flow of patients with Raynaud's Phenomenon, which can lead to a decrease in pain associated, frequency and severity of ischemic attacks and therefore an improvement in the functionality of the upper limbs.
The experimental group will receive an electrotherapy treatment using galvanic current. To apply the treatment, we will place the patient seated, with their hands inside two containers filled with water up to the limit of their nails without touching them. Next we will connect the electrodes and apply a galvanic current for 10 minutes, there will be a minute of rest for the patient while we change the polarity of this current and we will apply it another 10 minutes. The intensity of the current depends on the threshold of the patient.
The control group will maintain their usual conservative and pharmacological treatment without receiving electrotherapy
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being over 18 years of age.
- •Being diagnosed with Primary or Secondary Raynaud Phenomenon according to the criteria established by LeRoy-Medsger.
- •A history of at least one year of regular attacks of pallor or acral cyanosis caused by exposure to cold and/or stress.
- •Having signed the informed consent document and willingness to participate in the study
排除标准
- •Presence of skin alterations such as stings, scars, ulcers or gangrene in the examined area.
- •Suffering upper limb entrapment syndrome, central nervous system polyneuropathy, Hypothyroidism, renal failure, cerebral or cardiac ischemic disease.
- •History of drug or alcohol abuse.
- •Pregnant or breastfeeding women.
- •Use of vibratory tools.
- •Participants with tumour process.
研究组 & 干预措施
Electric Stimulation Therapy Group
The experimental group will receive an electrotherapy treatment with galvanic current in their hands. Electrotherapy with galvanic current has vasodilator action.
干预措施: Electrotherapy with Galvanic Current (Other)
Control Group
The control group will be subjected to a conservative treatment. These patients will continue to take their usual medication and will not receive electrotherapy treatment
干预措施: Control without Electric Stimulation Therapy (Other)
结局指标
主要结局
Number of Raynaud´s Phenomenon attacks
时间窗: Seven Weeks
Change from baseline at the Number of Raynaud´s Phenomenon attacks
次要结局
- Temperature in the affected areas in patients with Raynaud´s Disease(Fifteen weeks)
- Temperature in the Cold Stress Test(Fifteen weeks)
- Pain Intensity: Visual Analog Scale(Fifteen weeks)
- Central Sensitization(Fifteen weeks)
- Pain Catastrophizing(Fifteen weeks)
- Oxygen Saturation(Fifteen weeks)
- Arterial blood flow(Fifteen weeks)
- Upper limb disability(Fifteen Weeks)
- Temperature in the affected areas in patients with Raynaud´s Disease(Seven weeks)
- Temperature in the Cold Stress Test(Seven weeks)
- Pain Intensity: Visual Analog Scale(Seven weeks)
- Central Sensitization(Seven weeks)
- Pain Catastrophizing(Seven weeks)
- Oxygen Saturation(Seven weeks)
- Arterial blood flow(Seven weeks)
- Upper limb disability(Seven Weeks)
研究者
Encarnación Aguilar Ferrandiz
Research and teaching staff of the University of Granada
Universidad de Granada