Effectiveness of Electric Stimulation Therapy in Raynaud's Phenomenon
NCT ID: NCT03699436
Last Updated: 2020-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2018-10-01
2019-02-20
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Electrotherapy with Galvanic Current
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.
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
Control without Electric Stimulation Therapy
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.
Interventions
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Electrotherapy with Galvanic Current
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.
Control without Electric Stimulation Therapy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Universidad de Granada
OTHER
Responsible Party
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Encarnación Aguilar Ferrandiz
Research and teaching staff of the University of Granada
Principal Investigators
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Mª Encarnacion ME Aguilar Ferrandiz, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Granada
Locations
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University of Granada
Granada, , Spain
Countries
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Other Identifiers
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Ray-2016
Identifier Type: -
Identifier Source: org_study_id