Clinical Effects of Radiofrequency in Fibromyalgia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Effects of a Single-session of Radiofrequency on Vascular Response and Pain Thresholds in Patients With Fibromyalgia: a Randomized Clinical Trial

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Single-session of Radiofrequency
* Device: Control Placebo single-session of Radiofrequency


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Fibromyalgia in accordance with the American College of Rheumatology criteria for classifying Fibromyalgia (2016 revision) by a rheumatologist of the Public Health System of Andalusia (Spain) 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: Male sex 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency Therapy Group<br>The experimental group will receive a single-session of radiofrequency in their hands that has vasodilator action. | Device: Single-session of Radiofrequency<br>* 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.<br>* Other names: Electric Stimulation Therapy;|
| Placebo Comparator: Placebo Comparator: Control Group<br>The placebo group will receive a single placebo radiofrequency session with the machine in pause mode. | Device: Control Placebo single-session of Radiofrequency<br>* 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.<br>* Other names: Control Placebo Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral vascular blood flow | Change from baseline temperature in the infrared thermography of the hands as indirect measure of peripheral vascular blood flow | At the end of the radiofrequency session, an average of 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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 | At the end of the radiofrequency session, an average of 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiofrequency Therapy, Peripheral blow flow, Core body temperature, Pain, Central sensitization, Peripheral nervous system, Thermography