Clinical Effects of Radiofrequency in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05641740
• Other study ID #: RADIO-Fibromyalgia
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Spain	University of Granada	Granada	Andalusia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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