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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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.
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.
University of Granada
Granada, Spain
Number of Raynaud´s Phenomenon attacks
Change from baseline at the Number of Raynaud´s Phenomenon attacks
Time frame: 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
Time frame: 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
Time frame: Fifteen weeks
Temperature in the Cold Stress Test
Change from temperature in the Cold Stress Test
Time frame: Seven weeks
Temperature in the Cold Stress Test
Change from temperature in the Cold Stress Test
Time frame: 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.
Time frame: 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.
Time frame: Fifteen weeks
Central Sensitization
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Fifteen weeks
Oxygen Saturation
Change from baseline in Oxygen Saturation
Time frame: Seven weeks
Oxygen Saturation
Change from baseline in Oxygen Saturation
Time frame: Fifteen weeks
Arterial blood flow
Change from baseline in Arterial blood flow in the radial and ulnar artery
Time frame: Seven weeks
Arterial blood flow
Change from baseline in Arterial blood flow in the radial and ulnar artery
Time frame: 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.
Time frame: 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.
Time frame: Fifteen Weeks