Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2022-01-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Radiofrequency Therapy Group
The experimental group will receive a single-session of radiofrequency in their hands that has vasodilator action.
Single-session of Radiofrequency
The experimental group continue with their usual conservative and pharmacological treatment and will receive a single-session of monopolar dielectric capacitive radiofrequency in their hands. An Biotronic Advance Develops® (ABD-S25v) with a carrier wave frequency of 800-900 KHz of 850 KHz will be used. Patients will be placed in a seated position, with the forearms supinated and resting on a wooden table. An almond oil conductor will be applied to the hands. The application will be carried out with a circular head of 5 cm2 and for a total of 10 minutes on each of the palms of the hands.
They will be evaluated at baseline and post-session.
Placebo Comparator: Control Group
The placebo group will receive a single placebo radiofrequency session with the machine in pause mode.
Control Placebo single-session of Radiofrequency
The control placebo group continue with their usual conservative and pharmacological treatment and will receive a placebo single-session of radiofrequency. This group will follow the same protocol and treatment time, but they will receive a placebo treatment (the device remains in paused mode), so that radiofrequency will not be applied.
They will be evaluated at baseline and post-session.
Interventions
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Single-session of Radiofrequency
The experimental group continue with their usual conservative and pharmacological treatment and will receive a single-session of monopolar dielectric capacitive radiofrequency in their hands. An Biotronic Advance Develops® (ABD-S25v) with a carrier wave frequency of 800-900 KHz of 850 KHz will be used. Patients will be placed in a seated position, with the forearms supinated and resting on a wooden table. An almond oil conductor will be applied to the hands. The application will be carried out with a circular head of 5 cm2 and for a total of 10 minutes on each of the palms of the hands.
They will be evaluated at baseline and post-session.
Control Placebo single-session of Radiofrequency
The control placebo group continue with their usual conservative and pharmacological treatment and will receive a placebo single-session of radiofrequency. This group will follow the same protocol and treatment time, but they will receive a placebo treatment (the device remains in paused mode), so that radiofrequency will not be applied.
They will be evaluated at baseline and post-session.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age from 18 to 70 years
* No other rheumatic diseases
* Absence of regular physical activity
* Limitation of usual activities due to pain on at least 1 day out of the previous 30
Exclusion Criteria
* Presence of cardiac, renal or hepatic insufficiency;
* Severe physical disability
* Pregnancy or lactation
* Active infections
* Psychiatric illness
* Active tumor.
* Treatment with vasoactive drugs or anticoagulants or a history of drug use
* Skin disorders
* Any other non-pharmacological therapy
18 Years
70 Years
FEMALE
No
Sponsors
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Universidad de Granada
OTHER
Responsible Party
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Encarnación Aguilar Ferrandiz
Research and teaching staff of the University of Granada
Principal Investigators
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Mª Encarnación ME Aguilar Ferrándiz, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Granada
Locations
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University of Granada
Granada, Andalusia, Spain
Countries
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Other Identifiers
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RADIO-Fibromyalgia
Identifier Type: -
Identifier Source: org_study_id
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