Raynaud Phenomenon Clinical Trial
Official title:
Effectiveness of an Intervention Program With Electric Stimulation Therapy in Patients With Raynaud's Phenomenon: a Randomized Clinical Trial
Verified date | November 2020 |
Source | Universidad de Granada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 20, 2019 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | University of Granada | Granada |
Lead Sponsor | Collaborator |
---|---|
Universidad de Granada |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Raynaud´s Phenomenon attacks | Change from baseline at the Number of Raynaud´s Phenomenon attacks | Seven Weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Temperature in the Cold Stress Test | Change from temperature in the Cold Stress Test | Seven weeks | |
Secondary | Temperature in the Cold Stress Test | Change from temperature in the Cold Stress Test | Fifteen weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Oxygen Saturation | Change from baseline in Oxygen Saturation | Seven weeks | |
Secondary | Oxygen Saturation | Change from baseline in Oxygen Saturation | Fifteen weeks | |
Secondary | Arterial blood flow | Change from baseline in Arterial blood flow in the radial and ulnar artery | Seven weeks | |
Secondary | Arterial blood flow | Change from baseline in Arterial blood flow in the radial and ulnar artery | Fifteen weeks | |
Secondary | 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 | |
Secondary | 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 |
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