Back to resultsClinical Effects of Radiofrequency in Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Single-session of Radiofrequency
Control Placebo single-session of Radiofrequency
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Radiofrequency Therapy, Peripheral blow flow, Core body temperature, Pain, Central sensitization, Peripheral nervous system, Thermography
Eligibility Criteria
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
Sites / Locations
- University of Granada
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Radiofrequency Therapy Group
Placebo Comparator: Control Group
Arm Description
The experimental group will receive a single-session of radiofrequency in their hands that has vasodilator action.
The placebo group will receive a single placebo radiofrequency session with the machine in pause mode.
Outcomes
Primary Outcome Measures
Peripheral vascular blood flow
Change from baseline temperature in the infrared thermography of the hands as indirect measure of peripheral vascular blood flow
Secondary Outcome Measures
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.
Pain Threshold Electric Score
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
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
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
Change from baseline in core body temperature in patients with Fibromyalgia
Full Information
NCT ID
NCT05641740
First Posted
November 17, 2022
Last Updated
February 1, 2023
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT05641740
Brief Title
Clinical Effects of Radiofrequency in Fibromyalgia
Official Title
Clinical Effects of a Single-session of Radiofrequency on Vascular Response and Pain Thresholds in Patients With Fibromyalgia: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Radiofrequency Therapy, Peripheral blow flow, Core body temperature, Pain, Central sensitization, Peripheral nervous system, Thermography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiofrequency Therapy Group
Arm Type
Experimental
Arm Description
The experimental group will receive a single-session of radiofrequency in their hands that has vasodilator action.
Arm Title
Placebo Comparator: Control Group
Arm Type
Placebo Comparator
Arm Description
The placebo group will receive a single placebo radiofrequency session with the machine in pause mode.
Intervention Type
Device
Intervention Name(s)
Single-session of Radiofrequency
Other Intervention Name(s)
Electric Stimulation Therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control Placebo single-session of Radiofrequency
Other Intervention Name(s)
Control Placebo Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peripheral vascular blood flow
Description
Change from baseline temperature in the infrared thermography of the hands as indirect measure of peripheral vascular blood flow
Time Frame
At the end of the radiofrequency session, an average of 20 minutes
Secondary Outcome Measure Information:
Title
Pain Intensity: Visual Analog Scale
Description
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.
Time Frame
At the end of the radiofrequency session, an average of 20 minutes
Title
Pain Threshold Electric Score
Description
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
Time Frame
At the end of the radiofrequency session, an average of 20 minutes
Title
Pain Intensity Electric Score
Description
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
Time Frame
At the end of the radiofrequency session, an average of 20 minutes
Title
Pressure Pain Threshold
Description
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
Time Frame
At the end of the radiofrequency session, an average of 20 minutes
Title
Core body temperature
Description
Change from baseline in core body temperature in patients with Fibromyalgia
Time Frame
At the end of the radiofrequency session, an average of 20 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mª Encarnación ME Aguilar Ferrándiz, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Granada
City
Granada
State/Province
Andalusia
ZIP/Postal Code
18001
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Clinical Effects of Radiofrequency in Fibromyalgia
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