Clinical Trials Directory

Trials / Completed

CompletedNCT05641740

Clinical Effects of Radiofrequency in Fibromyalgia

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Universidad de Granada · Academic / Other
Sex
Female
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICESingle-session of RadiofrequencyThe 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.
DEVICEControl Placebo single-session of RadiofrequencyThe 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.

Timeline

Start date
2022-01-01
Primary completion
2022-12-31
Completion
2022-12-31
First posted
2022-12-08
Last updated
2023-02-02

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT05641740. Inclusion in this directory is not an endorsement.