Effectiveness of Electric Stimulation Therapy in Raynaud's Phenomenon

Effectiveness of an Intervention Program With Electric Stimulation Therapy in Patients With Raynaud's Phenomenon: a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Raynaud Disease; Raynaud Phenomenon
• Intervention / Treatment: Other: Electrotherapy with Galvanic Current; Other: Control without Electric Stimulation Therapy

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18001
    • University of Granada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Other Names: Electric Stimulation Therapy
Active Comparator: 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	Other: 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 Names: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Raynaud´s Phenomenon attacks	Change from baseline at the Number of Raynaud´s Phenomenon attacks	Seven Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Fifteen weeks
Temperature in the Cold Stress Test	Change from temperature in the Cold Stress Test	Seven weeks
Temperature in the Cold Stress Test	Change from temperature in the Cold Stress Test	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.	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.	Fifteen 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.	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.	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.	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.	Fifteen weeks
Oxygen Saturation	Change from baseline in Oxygen Saturation	Seven weeks
Oxygen Saturation	Change from baseline in Oxygen Saturation	Fifteen weeks
Arterial blood flow	Change from baseline in Arterial blood flow in the radial and ulnar artery	Seven weeks
Arterial blood flow	Change from baseline in Arterial blood flow in the radial and ulnar artery	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.	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.	Fifteen Weeks

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: Mª Encarnación ME Aguilar Ferrándiz, PhD, Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): February 20, 2019

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Temperature; Peripheral blow flow; Central Sensitization; Vascular alterations; Galvanic current; Upper limb functionality; Pain catastrophizing.; Number of attacks
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Peripheral Vascular Diseases; Raynaud Disease
• Other Study ID Numbers: Ray-2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No