Clinical trial NCT03699436: Effectiveness of Electric Stimulation Therapy in Raynaud's Phenomenon
Official title: Effectiveness of an Intervention Program With Electric Stimulation Therapy in Patients With Raynaud's Phenomenon: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Raynaud Phenomenon
Raynaud Disease
Keywords: Vascular alterations
Galvanic current
Pain
Peripheral blow flow
Temperature
Upper limb functionality
Central Sensitization
Pain catastrophizing.
Number of attacks
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Raynaud´s Phenomenon attacks
timeFrame: Seven Weeks
Secondary outcomes:
measure: Temperature in the affected areas in patients with Raynaud´s Disease
timeFrame: Seven weeks
measure: Temperature in the affected areas in patients with Raynaud´s Disease
timeFrame: Fifteen weeks
measure: Temperature in the Cold Stress Test
timeFrame: Seven weeks
measure: Temperature in the Cold Stress Test
timeFrame: Fifteen weeks
measure: Pain Intensity: Visual Analog Scale
timeFrame: Seven weeks
measure: Pain Intensity: Visual Analog Scale
timeFrame: Fifteen weeks
measure: Central Sensitization
timeFrame: Seven weeks
measure: Central Sensitization
timeFrame: Fifteen weeks
measure: Pain Catastrophizing
timeFrame: Seven weeks
measure: Pain Catastrophizing
timeFrame: Fifteen weeks
measure: Oxygen Saturation
timeFrame: Seven weeks
measure: Oxygen Saturation
timeFrame: Fifteen weeks
measure: Arterial blood flow
timeFrame: Seven weeks
measure: Arterial blood flow
timeFrame: Fifteen weeks
measure: Upper limb disability
timeFrame: Seven Weeks
measure: Upper limb disability
timeFrame: Fifteen Weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
affiliation: Universidad de Granada
name: Mª Encarnacion ME Aguilar Ferrandiz, PhD
role: PRINCIPAL_INVESTIGATOR
References: