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Completed

NCT Number: NCT05641740

Clinical Effects of Radiofrequency in Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Granada

Granada, Andalusia, 18001, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single-session of Radiofrequency

Device

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

Control Placebo single-session of Radiofrequency

Device

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

Primary outcomes

  1. Peripheral vascular blood flow

    Time frame: At the end of the radiofrequency session, an average of 20 minutes

    Change from baseline temperature in the infrared thermography of the hands as indirect measure of peripheral vascular blood flow

Secondary outcomes

  1. Pain Intensity: Visual Analog Scale

    Time frame: At the end of the radiofrequency session, an average of 20 minutes

    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.

  2. Pain Threshold Electric Score

    Time frame: At the end of the radiofrequency session, an average of 20 minutes

    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

  3. Pain Intensity Electric Score

    Time frame: At the end of the radiofrequency session, an average of 20 minutes

    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

  4. Pressure Pain Threshold

    Time frame: At the end of the radiofrequency session, an average of 20 minutes

    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

  5. Core body temperature

    Time frame: At the end of the radiofrequency session, an average of 20 minutes

    Change from baseline in core body temperature in patients with Fibromyalgia

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 8, 2022
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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