Clinical Effects of Radiofrequency in Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Device: Single-session of RadiofrequencyDevice: Control Placebo single-session of Radiofrequency
- Registration Number
- NCT05641740
- Lead Sponsor
- Universidad de Granada
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radiofrequency Therapy Group Single-session of Radiofrequency The experimental group will receive a single-session of radiofrequency in their hands that has vasodilator action. Placebo Comparator: Control Group Control Placebo single-session of Radiofrequency The placebo group will receive a single placebo radiofrequency session with the machine in pause mode.
- Primary Outcome Measures
Name Time Method Peripheral vascular blood flow 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 Outcome Measures
Name Time Method Pain Threshold Electric Score 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
Pain Intensity: Visual Analog Scale 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.
Pain Intensity Electric Score 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
Core body temperature At the end of the radiofrequency session, an average of 20 minutes Change from baseline in core body temperature in patients with Fibromyalgia
Pressure Pain Threshold 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
Trial Locations
- Locations (1)
University of Granada
🇪🇸Granada, Andalusia, Spain