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Effectiveness of Electric Stimulation Therapy in Raynaud's Phenomenon

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ClinicalTrials.gov Identifier: NCT03699436
Recruitment Status : Recruiting
First Posted : October 8, 2018
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Encarnación Aguilar Ferrandiz, 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.

Condition or disease Intervention/treatment Phase
Raynaud Phenomenon Raynaud Disease Other: Electrotherapy with Galvanic Current Other: Control without Electric Stimulation Therapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of an Intervention Program With Electric Stimulation Therapy in Patients With Raynaud's Phenomenon: a Randomized Clinical Trial
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Control Group




Primary Outcome Measures :
  1. Number of Raynaud´s Phenomenon attacks [ Time Frame: Seven Weeks ]
    Change from baseline at the Number of Raynaud´s Phenomenon attacks


Secondary Outcome Measures :
  1. Temperature in the affected areas in patients with Raynaud´s Disease [ Time Frame: Seven weeks ]
    Change from baseline temperature in the infrared thermography in patients with Raynaud´s Disease

  2. Temperature in the affected areas in patients with Raynaud´s Disease [ Time Frame: Fifteen weeks ]
    Change from baseline temperature in the infrared thermography in patients with Raynaud´s Disease

  3. Temperature in the Cold Stress Test [ Time Frame: Seven weeks ]
    Change from temperature in the Cold Stress Test

  4. Temperature in the Cold Stress Test [ Time Frame: Fifteen weeks ]
    Change from temperature in the Cold Stress Test

  5. Pain Intensity: Visual Analog Scale [ Time Frame: Seven 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.

  6. Pain Intensity: Visual Analog Scale [ Time Frame: 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.

  7. Central Sensitization [ Time Frame: Seven 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.

  8. Central Sensitization [ Time Frame: 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.

  9. Pain Catastrophizing [ Time Frame: Seven 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.

  10. Pain Catastrophizing [ Time Frame: 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.

  11. Oxygen Saturation [ Time Frame: Seven weeks ]
    Change from baseline in Oxygen Saturation

  12. Oxygen Saturation [ Time Frame: Fifteen weeks ]
    Change from baseline in Oxygen Saturation

  13. Arterial blood flow [ Time Frame: Seven weeks ]
    Change from baseline in Arterial blood flow in the radial and ulnar artery

  14. Arterial blood flow [ Time Frame: Fifteen weeks ]
    Change from baseline in Arterial blood flow in the radial and ulnar artery

  15. Upper limb disability [ Time Frame: Seven 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.

  16. Upper limb disability [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699436


Contacts
Contact: Mª Encarnacion ME Aguilar Ferrandiz, PhD +34669546384 encaguilar@hotmail.com
Contact: Rosa María RM Tapia Haro, PhD +34677799601 rosa_taha@hotmail.com

Locations
Spain
University of Granada Recruiting
Granada, Spain, 18001
Contact: MªEncarnacion ME Aguilar, PT    +34669546384    encaguilar@hotmail.com   
Sub-Investigator: MªEncarnacion ME Aguilar, PT         
Sponsors and Collaborators
Universidad de Granada
Investigators
Principal Investigator: Mª Encarnacion ME Aguilar Ferrandiz, PhD Universidad de Granada

Responsible Party: Encarnación Aguilar Ferrandiz, Research and teaching staff of the University of Granada, Universidad de Granada
ClinicalTrials.gov Identifier: NCT03699436     History of Changes
Other Study ID Numbers: Ray-2016
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Encarnación Aguilar Ferrandiz, Universidad de Granada:
Vascular alterations
Galvanic current
Pain
Peripheral blow flow
Temperature
Upper limb functionality
Central Sensitization
Pain catastrophizing.
Number of attacks

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases