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Effectiveness of Electric Stimulation Therapy in Raynaud's Phenomenon

Primary Purpose

Raynaud Phenomenon, Raynaud Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Electrotherapy with Galvanic Current
Control without Electric Stimulation Therapy
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Raynaud Phenomenon focused on measuring Vascular alterations, Galvanic current, Pain, Peripheral blow flow, Temperature, Upper limb functionality, Central Sensitization, Pain catastrophizing., Number of attacks

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Granada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electric Stimulation Therapy Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Temperature in the Cold Stress Test
Change from temperature in the Cold Stress Test
Temperature in the Cold Stress Test
Change from temperature in the Cold Stress Test
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.
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.
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.
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.
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.
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.
Oxygen Saturation
Change from baseline in Oxygen Saturation
Oxygen Saturation
Change from baseline in Oxygen Saturation
Arterial blood flow
Change from baseline in Arterial blood flow in the radial and ulnar artery
Arterial blood flow
Change from baseline in Arterial blood flow in the radial and ulnar artery
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.
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.

Full Information

First Posted
October 4, 2018
Last Updated
November 6, 2020
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT03699436
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
February 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud Phenomenon, Raynaud Disease
Keywords
Vascular alterations, Galvanic current, Pain, Peripheral blow flow, Temperature, Upper limb functionality, Central Sensitization, Pain catastrophizing., Number of attacks

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electric Stimulation Therapy Group
Arm Type
Experimental
Arm Description
The experimental group will receive an electrotherapy treatment with galvanic current in their hands. Electrotherapy with galvanic current has vasodilator action.
Arm Title
Control Group
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Electrotherapy with Galvanic Current
Other Intervention Name(s)
Electric Stimulation Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control without Electric Stimulation Therapy
Other Intervention Name(s)
Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Raynaud´s Phenomenon attacks
Description
Change from baseline at the Number of Raynaud´s Phenomenon attacks
Time Frame
Seven Weeks
Secondary Outcome Measure Information:
Title
Temperature in the affected areas in patients with Raynaud´s Disease
Description
Change from baseline temperature in the infrared thermography in patients with Raynaud´s Disease
Time Frame
Seven weeks
Title
Temperature in the affected areas in patients with Raynaud´s Disease
Description
Change from baseline temperature in the infrared thermography in patients with Raynaud´s Disease
Time Frame
Fifteen weeks
Title
Temperature in the Cold Stress Test
Description
Change from temperature in the Cold Stress Test
Time Frame
Seven weeks
Title
Temperature in the Cold Stress Test
Description
Change from temperature in the Cold Stress Test
Time Frame
Fifteen weeks
Title
Pain Intensity: Visual Analog Scale
Description
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.
Time Frame
Seven weeks
Title
Pain Intensity: Visual Analog Scale
Description
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.
Time Frame
Fifteen weeks
Title
Central Sensitization
Description
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.
Time Frame
Seven weeks
Title
Central Sensitization
Description
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.
Time Frame
Fifteen weeks
Title
Pain Catastrophizing
Description
Change from baseline in the Pain Catastrophizing Scale. Score range is from 0 to 52; higher scores indicate a greater frequency of catastrophic thoughts.
Time Frame
Seven weeks
Title
Pain Catastrophizing
Description
Change from baseline in the Pain Catastrophizing Scale. Score range is from 0 to 52; higher scores indicate a greater frequency of catastrophic thoughts.
Time Frame
Fifteen weeks
Title
Oxygen Saturation
Description
Change from baseline in Oxygen Saturation
Time Frame
Seven weeks
Title
Oxygen Saturation
Description
Change from baseline in Oxygen Saturation
Time Frame
Fifteen weeks
Title
Arterial blood flow
Description
Change from baseline in Arterial blood flow in the radial and ulnar artery
Time Frame
Seven weeks
Title
Arterial blood flow
Description
Change from baseline in Arterial blood flow in the radial and ulnar artery
Time Frame
Fifteen weeks
Title
Upper limb disability
Description
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.
Time Frame
Seven Weeks
Title
Upper limb disability
Description
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.
Time Frame
Fifteen Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mª Encarnacion ME Aguilar Ferrandiz, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Granada
City
Granada
ZIP/Postal Code
18001
Country
Spain

12. IPD Sharing Statement

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Effectiveness of Electric Stimulation Therapy in Raynaud's Phenomenon

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