Fibromyalgia
Conditions
Keywords
Radiofrequency Therapy, Peripheral blow flow, Core body temperature, Pain, Central sensitization, Peripheral nervous system, Thermography
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.
Interventions
DEVICESingle-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.
DEVICEControl 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.
Sponsors
Universidad de Granada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 |
| 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 |
Countries
Spain
Outcome results
None listed