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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency Therapy Group | Experimental | The experimental group will receive a single-session of radiofrequency in their hands that has vasodilator action. |
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| Placebo Comparator: Control Group | Placebo Comparator | The placebo group will receive a single placebo radiofrequency session with the machine in pause mode. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity: Visual Analog Scale | 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. | At the end of the radiofrequency session, an average of 20 minutes |
| Pain Threshold Electric Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mª Encarnación ME Aguilar Ferrándiz, PhD | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Granada | Granada | Andalusia | 18001 | Spain |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| 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. |
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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 |
| At the end of the radiofrequency session, an average of 20 minutes |
| Pain Intensity Electric Score | 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 | At the end of the radiofrequency session, an average of 20 minutes |
| Pressure Pain Threshold | 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 | At the end of the radiofrequency session, an average of 20 minutes |
| Core body temperature | Change from baseline in core body temperature in patients with Fibromyalgia | At the end of the radiofrequency session, an average of 20 minutes |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |