FibromyalgiaNCT05641740
Clinical Effects of Radiofrequency in Fibromyalgia
A study testing Single-session of Radiofrequency in people with Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Single-session of Radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Male sex
- Presence of cardiac, renal or hepatic insufficiency;
- Severe physical disability
- Pregnancy or lactation
- Active infections
- Psychiatric illness
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- Active tumor.
- Treatment with vasoactive drugs or anticoagulants or a history of drug use
- Skin disorders
- Any other non-pharmacological therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effects of a Single-session of Radiofrequency on Vascular Response and Pain Thresholds in Patients With Fibromyalgia: a Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Single-session of Radiofrequency, Control Placebo single-session of Radiofrequency
- Keywords
- Radiofrequency Therapy, Peripheral blow flow, Core body temperature, Pain, Central sensitization, Peripheral nervous system, Thermography
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-session of RadiofrequencyDevice
Also called Electric Stimulation Therapy
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.
Control Placebo single-session of RadiofrequencyDevice
Also called Control Placebo Group
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency Therapy Group | Experimental | The experimental group will receive a single-session of radiofrequency in their hands that has vasodilator action. Receives: Device: Single-session of Radiofrequency |
| Placebo Comparator: Control Group | Placebo comparator | The placebo group will receive a single placebo radiofrequency session with the machine in pause mode. Receives: Device: Control Placebo single-session of Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral vascular blood flow
Change from baseline temperature in the infrared thermography of the hands as indirect measure of peripheral vascular blood flow
Measured: At the end of the radiofrequency session, an average of 20 minutes
Secondary outcomes (5)
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.
Measured: At the end of the radiofrequency session, an average of 20 minutes
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
Measured: 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
Measured: 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
Measured: 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
Measured: At the end of the radiofrequency session, an average of 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Encarnación Aguilar Ferrandiz, Universidad de Granada
- Investigators
- Mª Encarnación ME Aguilar Ferrándiz, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641740
- Sponsor's protocol ID
- RADIO-Fibromyalgia
- Status last verified
- Feb 2023
- First submitted
- 17 Nov 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of a Single-session of Radiofrequency on Vascular Response and Pain Thresholds in Patients With Fibromyalgia: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05641740
- Acronym / sponsor ID
- RADIO-Fibromyalgia
- Conditions
- Fibromyalgia
- Keywords
- Radiofrequency Therapy, Peripheral blow flow, Core body temperature, Pain, Central sensitization, Peripheral nervous system, Thermography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Therapy Group | Experimental | Device: Single-session of RadiofrequencyThe experimental group will receive a single-session of radiofrequency in their hands that has vasodilator action. |
| Placebo Comparator: Control Group | Placebo comparator | Device: Control Placebo single-session of RadiofrequencyThe placebo group will receive a single placebo radiofrequency session with the machine in pause mode. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Male sex
- Presence of cardiac, renal or hepatic insufficiency;
- Severe physical disability
- Pregnancy or lactation
- Active infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-session of RadiofrequencyAlso: Electric Stimulation TherapyThe 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. | Device | Radiofrequency Therapy Group |
| Control Placebo single-session of RadiofrequencyAlso: Control Placebo GroupThe 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. | Device | Placebo Comparator: Control Group |
Primary outcome
Peripheral vascular blood flow
Time frame: 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
5 secondary outcomes
Pain Intensity: Visual Analog Scale
Time frame: At the end of the radiofrequency session, an average of 20 minutes
Pain Threshold Electric Score
Time frame: At the end of the radiofrequency session, an average of 20 minutes
Pain Intensity Electric Score
Time frame: At the end of the radiofrequency session, an average of 20 minutes
Pressure Pain Threshold
Time frame: At the end of the radiofrequency session, an average of 20 minutes
Core body temperature
Time frame: At the end of the radiofrequency session, an average of 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mª Encarnación ME Aguilar Ferrándiz, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-session of Radiofrequency in people with Fibromyalgia, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral vascular blood flow (time frame: At the end of the radiofrequency session, an average of 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.