Effectiveness of Electric Stimulation Therapy in Raynaud's Phenomenon

NCT03699436 | Completed

• 1 other identifier: Ray-2016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of Raynaud´s Phenomenon attacks

  Change from baseline at the Number of Raynaud´s Phenomenon attacks

  Seven Weeks

Secondary Outcomes (16)

• Temperature in the affected areas in patients with Raynaud´s Disease

  Seven weeks

• Temperature in the affected areas in patients with Raynaud´s Disease

  Fifteen weeks

• Temperature in the Cold Stress Test

  Seven weeks

• Temperature in the Cold Stress Test

  Fifteen weeks

• Pain Intensity: Visual Analog Scale

  Seven weeks

Study Arms (2)

Electric Stimulation Therapy Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Electrotherapy with Galvanic Current OTHER

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.

Also known as: Electric Stimulation Therapy

Electric Stimulation Therapy Group

Control without Electric Stimulation Therapy OTHER

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.

Also known as: Control Group

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

University of Granada

Granada, 18001, Spain

Location

MeSH Terms

Conditions

Raynaud Disease; Pain

Interventions

Electric Stimulation Therapy; Control Groups

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mª Encarnacion ME Aguilar Ferrandiz, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research and teaching staff of the University of Granada

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: October 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: February 20, 2019
• Last Updated: November 9, 2020

Record last verified: 2020-11

Locations

ES (1)