Clinical Effects of Radiofrequency in Fibromyalgia

University of Granada (UGR)

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: Control Placebo single-session of Radiofrequency; Device: Single-session of Radiofrequency

Study type: Interventional

Funder types: Other

Identifiers

NCT05641740

RADIO-Fibromyalgia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Radiofrequency Therapy Group

Experimental group

Description:

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

Treatment:

Device: Single-session of Radiofrequency

Placebo Comparator: Control Group

Placebo Comparator group

Description:

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

Treatment:

Device: Control Placebo single-session of Radiofrequency