Effectiveness of Electric Stimulation Therapy in Raynaud's Phenomenon

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effectiveness of an Intervention Program With Electric Stimulation Therapy in Patients With Raynaud's Phenomenon: a Randomized Clinical Trial

Conditions
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Raynaud Phenomenon, Raynaud Disease

Intervention / Treatment
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* Other: Electrotherapy with Galvanic Current
* Other: Control without Electric Stimulation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electric Stimulation Therapy Group<br>The experimental group will receive an electrotherapy treatment with galvanic current in their hands. Electrotherapy with galvanic current has vasodilator action. | Other: Electrotherapy with Galvanic Current<br>* The experimental group will receive an electrotherapy treatment with galvanic current in their hands.This protocol will be administered at weekly sessions of 30 minutes with a period of 3 times / week with a total of 20 sessions, distributed over a 7-week period. They will be evaluated at baseline, after the end of the last treatment session and after two months of follow-up.<br>* Other names: Electric Stimulation Therapy;|
| Active Comparator: Control Group<br>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 | Other: Control without Electric Stimulation Therapy<br>* The control group continue with their usual conservative and pharmacological treatment and will not receive electrotherapy treatment. They will be evaluated too at baseline, after the end of the last treatment session and after two months of follow-up.<br>* Other names: Control Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Raynaud´s Phenomenon attacks | Change from baseline at the Number of Raynaud´s Phenomenon attacks | Seven Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature in the affected areas in patients with Raynaud´s Disease | Change from baseline temperature in the infrared thermography in patients with Raynaud´s Disease | Seven weeks | 
| Temperature in the affected areas in patients with Raynaud´s Disease | Change from baseline temperature in the infrared thermography in patients with Raynaud´s Disease | Fifteen weeks | 
| Temperature in the Cold Stress Test | Change from temperature in the Cold Stress Test | Seven weeks | 
| Temperature in the Cold Stress Test | Change from temperature in the Cold Stress Test | Fifteen weeks | 
| Pain Intensity: Visual Analog Scale | Change from baseline in pain in the Visual Analog Scale. Score range between 0-10 cm where 0 is in considerer no pain and 10 is the worst pain imaginable. | Seven weeks | 
| Pain Intensity: Visual Analog Scale | Change from baseline in pain in the Visual Analog Scale. Score range between 0-10 cm where 0 is in considerer no pain and 10 is the worst pain imaginable. | Fifteen weeks | 
| Central Sensitization | Change from baseline in the Central Sensitization Inventory. The cumulative score ranges from 0 to 100.Higher scores indicate increased frequency and severity of the symptoms. | Seven weeks | 
| Central Sensitization | Change from baseline in the Central Sensitization Inventory. The cumulative score ranges from 0 to 100.Higher scores indicate increased frequency and severity of the symptoms. | Fifteen weeks | 
| Pain Catastrophizing | Change from baseline in the Pain Catastrophizing Scale. Score range is from 0 to 52; higher scores indicate a greater frequency of catastrophic thoughts. | Seven weeks | 
| Pain Catastrophizing | Change from baseline in the Pain Catastrophizing Scale. Score range is from 0 to 52; higher scores indicate a greater frequency of catastrophic thoughts. | Fifteen weeks | 
| Oxygen Saturation | Change from baseline in Oxygen Saturation | Seven weeks | 
| Oxygen Saturation | Change from baseline in Oxygen Saturation | Fifteen weeks | 
| Arterial blood flow | Change from baseline in Arterial blood flow in the radial and ulnar artery | Seven weeks | 
| Arterial blood flow | Change from baseline in Arterial blood flow in the radial and ulnar artery | Fifteen weeks | 
| Upper limb disability | Change from baseline in the Disabilities of the Arm, Shoulder and Hand Questionnaire. The score ranges from 0 (no disability) to 100 (most severe disability). Higher scores indicate a greater level of disability and severity. | Seven Weeks | 
| Upper limb disability | Change from baseline in the Disabilities of the Arm, Shoulder and Hand Questionnaire. The score ranges from 0 (no disability) to 100 (most severe disability). Higher scores indicate a greater level of disability and severity. | Fifteen Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Vascular alterations, Galvanic current, Peripheral blow flow, Temperature, Upper limb functionality, Central Sensitization, Pain catastrophizing., Number of attacks