Clinical Effects of Radiofrequency in Fibromyalgia

NCT05641740 | Completed

• 1 other identifier: RADIO-Fibromyalgia
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Keywords

Radiofrequency Therapy; Peripheral blow flow; Core body temperature; Pain; Central sensitization; Peripheral nervous system; Thermography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain Intensity: Visual Analog Scale

  At the end of the radiofrequency session, an average of 20 minutes

• Pain Threshold Electric Score

  At the end of the radiofrequency session, an average of 20 minutes

• Pain Intensity Electric Score

  At the end of the radiofrequency session, an average of 20 minutes

• Pressure Pain Threshold

  At the end of the radiofrequency session, an average of 20 minutes

• Core body temperature

  At the end of the radiofrequency session, an average of 20 minutes

Study Arms (2)

Radiofrequency Therapy Group

EXPERIMENTAL

The experimental group will receive a single-session of radiofrequency in their hands that has vasodilator action.

Device: Single-session of Radiofrequency

Placebo Comparator: Control Group

PLACEBO COMPARATOR

The placebo group will receive a single placebo radiofrequency session with the machine in pause mode.

Device: Control Placebo single-session of Radiofrequency

Interventions

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.

Also known as: Electric Stimulation Therapy

Radiofrequency Therapy Group

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.

Also known as: Control Placebo Group

Placebo Comparator: Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

University of Granada

Granada, Andalusia, 18001, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Mª Encarnación ME Aguilar Ferrándiz, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research and teaching staff of the University of Granada

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 8, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-02

Locations

ES (1)