The aim of this study is to analyze the effects of a single-session of Radiofrequency in patients with Fibromyalgia in comparison to a placebo group.
The aim of this study is to analyze the effects of a single-session of Radiofrequency on peripheral vascular blood flow of the skin of the hands and core body temperature in patients with Fibromyalgia in comparison to a placebo group. Also, to study the clinical effects of the intervention on subjective pain perception, pain threshold to pressure and electrical pain threshold and intensity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
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.
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.
University of Granada
Granada, Andalusia, Spain
Peripheral vascular blood flow
Change from baseline temperature in the infrared thermography of the hands as indirect measure of peripheral vascular blood flow
Time frame: At the end of the radiofrequency session, an average of 20 minutes
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 considered no pain and 10 is the worst pain imaginable.
Time frame: At the end of the radiofrequency session, an average of 20 minutes
Pain Threshold Electric Score
Change from baseline in the pain threshold electric score. We use the Pain Matcher a device that applied an electric current among the thumb and index finger with three recordings for pain threshold with a score ranging from 0 to 60
Time frame: At the end of the radiofrequency session, an average of 20 minutes
Pain Intensity Electric Score
Change from baseline in the pain intensity electric score. We use the Pain Matcher a device that applied an electric current among the thumb and index finger with three recordings for pain intensity with a score ranging from 0 to 60
Time frame: At the end of the radiofrequency session, an average of 20 minutes
Pressure Pain Threshold
Change from baseline un pressure pain threshold. A digital pressure algometer will be use to measure the pressure pain threshold bilaterally over 11 tender points considered by the American College of Rheumatology for Fibromyalgia diagnosis
Time frame: At the end of the radiofrequency session, an average of 20 minutes
Core body temperature
Change from baseline in core body temperature in patients with Fibromyalgia
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Time frame: At the end of the radiofrequency session, an average of 20 minutes