Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Raynaud´s Phenomenon attacks | Change from baseline at the Number of Raynaud´s Phenomenon attacks | Seven Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Temperature in the affected areas in patients with Raynaud´s Disease |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MÂŞ Encarnacion ME Aguilar Ferrandiz, PhD | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Granada | Granada | 18001 | Spain |
Not provided
| ID | Term |
|---|---|
| D011928 | Raynaud Disease |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D015340 | Epidemiologic Research Design |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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. |
|
|
Change from baseline temperature in the infrared thermography in patients with Raynaud´s Disease
| Fifteen weeks |
| Temperature in the Cold Stress Test | Change from temperature in the Cold Stress Test | Seven weeks |
| Temperature in the Cold Stress Test | Change from temperature in the Cold Stress Test | Fifteen weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Oxygen Saturation | Change from baseline in Oxygen Saturation | Seven weeks |
| Oxygen Saturation | Change from baseline in Oxygen Saturation | Fifteen weeks |
| Arterial blood flow | Change from baseline in Arterial blood flow in the radial and ulnar artery | Seven weeks |
| Arterial blood flow | Change from baseline in Arterial blood flow in the radial and ulnar artery | Fifteen weeks |
| 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 |
| 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 |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004812 |
| Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |