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Completed

NCT Number: NCT03699436

Effectiveness of Electric Stimulation Therapy in Raynaud's Phenomenon

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.

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Key information

Conditions

Raynaud Phenomenon Cardiovascular Diseases Embolism and Thrombosis Livedoid Vasculopathy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Raynaud Disease Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Granada

Granada, 18001, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Electric Stimulation Therapy

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.

Other names: Control Group

Primary outcomes

  1. Number of Raynaud´s Phenomenon attacks

    Time frame: Seven Weeks

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Oct 9, 2018
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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