Effectiveness of Electric Stimulation Therapy in Raynaud's Phenomenon

Not Applicable

Completed

• Conditions: Raynaud Phenomenon; Raynaud Disease
• Interventions: Other: Electrotherapy with Galvanic Current; Other: Control without Electric Stimulation Therapy

• Registration Number: NCT03699436
• Lead Sponsor: Universidad de Granada

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

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Primary Completion: 2018-12-01
• Study Completion: 2019-02-20
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electric Stimulation Therapy Group	Electrotherapy with Galvanic Current	The experimental group will receive an electrotherapy treatment with galvanic current in their hands. Electrotherapy with galvanic current has vasodilator action.
Control Group	Control without Electric Stimulation Therapy	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

Primary Outcome Measures

Name	Time	Method
Number of Raynaud´s Phenomenon attacks	Seven Weeks	Change from baseline at the Number of Raynaud´s Phenomenon attacks

Secondary Outcome Measures

Name	Time	Method
Temperature in the affected areas in patients with Raynaud´s Disease	Fifteen weeks	Change from baseline temperature in the infrared thermography in patients with Raynaud´s Disease
Temperature in the Cold Stress Test	Fifteen weeks	Change from temperature in the Cold Stress Test
Pain Intensity: Visual Analog Scale	Fifteen weeks	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.
Central Sensitization	Fifteen weeks	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.
Pain Catastrophizing	Fifteen weeks	Change from baseline in the Pain Catastrophizing Scale. Score range is from 0 to 52; higher scores indicate a greater frequency of catastrophic thoughts.
Oxygen Saturation	Fifteen weeks	Change from baseline in Oxygen Saturation
Arterial blood flow	Fifteen weeks	Change from baseline in Arterial blood flow in the radial and ulnar artery
Upper limb disability	Fifteen Weeks	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.

Trial Locations

Locations (1)

University of Granada; 🇪🇸 Granada, Spain