Effectiveness of Electric Stimulation Therapy in Raynaud's Phenomenon

University of Granada (UGR)

Status: Completed

Conditions: Raynaud Disease; Raynaud Phenomenon

Treatments: Other: Electrotherapy with Galvanic Current; Other: Control without Electric Stimulation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03699436

Ray-2016

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

Electric Stimulation Therapy Group

Experimental group

Description:

The experimental group will receive an electrotherapy treatment with galvanic current in their hands. Electrotherapy with galvanic current has vasodilator action.

Treatment:

Other: Electrotherapy with Galvanic Current

Control Group

Active Comparator group

Description:

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

Treatment:

Other: Control without Electric Stimulation Therapy