Raynaud PhenomenonNCT03699436
Effectiveness of Electric Stimulation Therapy in Raynaud's Phenomenon
A study testing Electrotherapy with Galvanic Current in people with Raynaud Phenomenon and Raynaud Disease, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Raynaud Phenomenon, Raynaud Disease
- What is being tested?
- Electrotherapy with Galvanic Current
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2018to 20 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Intervention Program With Electric Stimulation Therapy in Patients With Raynaud's Phenomenon: a Randomized Clinical Trial
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.
Read the 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
- Conditions
- Raynaud Phenomenon, Raynaud Disease
- Being tested
- Electrotherapy with Galvanic Current, Control without Electric Stimulation Therapy
- Keywords
- Vascular alterations, Galvanic current, Pain, Peripheral blow flow, Temperature, Upper limb functionality, Central Sensitization, Pain catastrophizing., Number of attacks
- Medical subject headings
- Raynaud Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrotherapy with Galvanic CurrentOther
Also called Electric Stimulation Therapy
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.
Control without Electric Stimulation TherapyOther
Also called Control Group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Electrotherapy with Galvanic Current |
| 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 Receives: Other: Control without Electric Stimulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Raynaud´s Phenomenon attacks
Change from baseline at the Number of Raynaud´s Phenomenon attacks
Measured: Seven Weeks
Secondary outcomes (16)
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
Measured: Seven weeks
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
Measured: Fifteen weeks
Temperature in the Cold Stress Test
Change from temperature in the Cold Stress Test
Measured: Seven weeks
Temperature in the Cold Stress Test
Change from temperature in the Cold Stress Test
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Fifteen weeks
Oxygen Saturation
Change from baseline in Oxygen Saturation
Measured: Seven weeks
Oxygen Saturation
Change from baseline in Oxygen Saturation
Measured: Fifteen weeks
Arterial blood flow
Change from baseline in Arterial blood flow in the radial and ulnar artery
Measured: Seven weeks
Arterial blood flow
Change from baseline in Arterial blood flow in the radial and ulnar artery
Measured: 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.
Measured: 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.
Measured: Fifteen Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Oct 2018
- Primary completion1 Dec 2018
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud PhenomenonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Encarnación Aguilar Ferrandiz, Universidad de Granada
- Investigators
- Mª Encarnacion ME Aguilar Ferrandiz, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699436
- Sponsor's protocol ID
- Ray-2016
- Status last verified
- Nov 2020
- First submitted
- 4 Oct 2018
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Intervention Program With Electric Stimulation Therapy in Patients With Raynaud's Phenomenon: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03699436
- Acronym / sponsor ID
- Ray-2016
- Conditions
- Raynaud Phenomenon, Raynaud Disease
- Keywords
- Vascular alterations, Galvanic current, Pain, Peripheral blow flow, Temperature, Upper limb functionality, Central Sensitization, Pain catastrophizing.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electric Stimulation Therapy Group | Experimental | Other: Electrotherapy with Galvanic CurrentThe experimental group will receive an electrotherapy treatment with galvanic current in their hands. Electrotherapy with galvanic current has vasodilator action. |
| Control Group | Active comparator | Other: Control without Electric Stimulation TherapyThe control group will be subjected to a conservative treatment. These patients will continue to take their usual medication and will not receive electrotherapy treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrotherapy with Galvanic CurrentAlso: Electric Stimulation TherapyThe 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 | Electric Stimulation Therapy Group |
| Control without Electric Stimulation TherapyAlso: Control GroupThe 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 | Control Group |
Primary outcome
Number of Raynaud´s Phenomenon attacks
Time frame: Seven Weeks
Change from baseline at the Number of Raynaud´s Phenomenon attacks
16 secondary outcomes
Temperature in the affected areas in patients with Raynaud´s Disease
Time frame: Seven weeks
Temperature in the affected areas in patients with Raynaud´s Disease
Time frame: Fifteen weeks
Temperature in the Cold Stress Test
Time frame: Seven weeks
Temperature in the Cold Stress Test
Time frame: Fifteen weeks
Pain Intensity: Visual Analog Scale
Time frame: Seven weeks
Pain Intensity: Visual Analog Scale
Time frame: Fifteen weeks
Central Sensitization
Time frame: Seven weeks
Central Sensitization
Time frame: Fifteen weeks
Pain Catastrophizing
Time frame: Seven weeks
Pain Catastrophizing
Time frame: Fifteen weeks
Oxygen Saturation
Time frame: Seven weeks
Oxygen Saturation
Time frame: Fifteen weeks
Arterial blood flow
Time frame: Seven weeks
Arterial blood flow
Time frame: Fifteen weeks
Upper limb disability
Time frame: Seven Weeks
Upper limb disability
Time frame: Fifteen Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
Related trials for Raynaud Phenomenon
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Not yet recruitingPhase 3
Efficacy of A Non-Invasive Botulinum Toxin Microneedle Pad for the Treatment of Secondary Raynaud's Phenomenon
Systemic Sclerosis (SSc), Raynaud Disease Secondary to Scleroderma
Not yet recruitingPhase 2
A Study of LIQ861 (Inhaled Treprostinil) in Adults With Systemic Sclerosis Who Have Symptomatic Raynaud's Phenomenon Attacks
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Not yet recruitingPhase 3
Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
Buerger Disease, Raynaud Syndrome
RecruitingPhase 2/3
Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk
Scleroderma, Systemic Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mª Encarnacion ME Aguilar Ferrandiz, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrotherapy with Galvanic Current in people with Raynaud Phenomenon and Raynaud Disease, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Raynaud´s Phenomenon attacks (time frame: Seven Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.