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

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.

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: Single-session of Radiofrequency; Device: Control Placebo single-session of Radiofrequency

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mª Encarnación ME Aguilar Ferrándiz, PhD; Phone Number: +34669546384; Email: encaguilar@hotmail.com
• Study Contact Backup: Name: Rosa María RM Tapia Haro, PhD; Phone Number: +34677799601; Email: rtapia@ugr.es

Study Locations

• Spain
  • Andalusia
    • Granada, Andalusia, Spain, 18001
      • Recruiting
      • University of Granada
      • Contact: Mª Encarnación ME Aguilar Ferrándiz, PhD; Phone Number: +34669546384; Email: encaguilar@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: Mª Encarnación ME Aguilar Ferrándiz, PhD, Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Radiofrequency Therapy; Thermography; Peripheral blow flow; Core body temperature; Central sensitization; Peripheral nervous system
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: RADIO-Fibromyalgia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No