CellulitisNCT03474523
Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment
A study testing Experimental group in people with Cellulitis, run by University of Cadiz at 1 site in Spain.
Trial summary
The aim of the present study is to value the effectiveness of Diathermy-Radiofrecuency treatment compared to Cavitation treatment in woman with cellulitis. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulitis
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 20 Oct 2017to 11 Mar 2020
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- UCA comunity
- Age 18-40 years
- Cellulite grade I, II, III (Nürnberg\&Müller clasification)
- Compliance of study timing
- Acceptance of informed consent and signature of study authorization
Who cannot join
- Pacemaker, heart diseases, epilepsy,
- pregnancy, lactation, last year postpartum, menstrual cycle alterations, climacteric, perimenopause
- chronic disease, hormonal or circulatory disorder, neoplasia process
- inflammation, infection, active acne, open wound in the treatment area
- BMI above 27 Kg/m2, obesity, lipoedema, oedema, circulatory problems
- Metal implants, prosthesis, intrauterine devices
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- Evolutive diseases
- Severe Artheryal hipertension
- High cholesterol levels or non-controlled triglycerides
- Weight fluctuation above 2 kg in the last six months
- Drinking more than two daily alcoholic drinks
- Pharmacological treatment during study: anti-inflammatory, esthetical, cosmetical or dietetic treatment
- Previous treatment of the studies areas in the last year
- Surgery intervention in studies areas
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Nursing and Physiotherapy. University of Cadiz
Cadiz, 11008
About this study
The aim of the present study is to value the effectiveness of Diathermy-Radiofrecuency treatment compared to Cavitation treatment in woman with cellulitis.
Read the detailed description
The edemato-fibrosclerotic panniculopathy is a segmental disease and lipodystrophy, this disease is localized in subcutaneous connective tissue which is influenced by venous and lymphatic system, when these systems are affected. The secondary vasomotor dysfunction to failure sympathetic nervous system influence on this disease too.
Usually it affects women, influencing their physical and psychological well-being.
The Aesthetic Physiotherapy, known as Aesthetics Plastic and Restorative Physiotherapy, is in their beginnings, there are little studies which present this pathology from the physiotherapy perspective. The investigators believe that their research could make some progress in this matter.
The search found very few clinical trials of scientific rigor about radio frequency and cavitation, and The investigators didn't find studies that compare both. Both treatments show effectiveness in improving the appearance of cellulite, so it would be a good idea compare them and see the most effective.
The investigators are trying to compare the effectiveness of both techniques and the investigators consider innovative and with added value to investigate something that we haven´t found in the reviewed literature.
The investigators choose 20 women randomly, 40 sample subjects, between 18-40 years old. These women must keep the inclusion criteria.
The participants attend a first date where the investigators collect the necessary data, and they are valued before and after the treatment (perimetry, photographic, Nürnberger and Müller scale, weight, height, BMI).
Then each patient receive treatment, seven non-consecutive sessions Diathermy-Radiofrequency on one leg (gluteal zone, internal and lateral zone, posterior and anterior zone) and other 7 sessions of Cavitation in the other leg, and Presotherapy in both legs.
The investigators also advice the participants about their diet and exercise.
- Conditions
- Cellulitis
- Being tested
- Experimental group, Control group
- Keywords
- radio frequency diathermy, cavitation, ultrasound, edemato-fibrosclerotic panniculopathy, cellulitis
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Cavitation: 70% intensity, 30 minutes apply plane electrode and 10 minutes focal electrode.
Presotherapy: 30 minutes application of 35% intensity, compression 35seg, pause 15seg, speed 9
Control groupOther
Diathermy-Radiofrecuency: 30 minutes at 70% intensity (40-43ºC) in manual resistive modality and 10 minutes in automatic capacitive modality.
Presotherapy: 30 minutes application of 35% intensity, compression 35seg, pause 15seg, speed 9
| Study group | Role | What they receive |
|---|---|---|
| Experimental or Diathermy-Radiofrecuency | Experimental | All patients are given a Combined Physiotherapy Protocol (CPP) consisting of: Diathermy-Radiofrecuency (manual 70% intensity of about 40-43º resistive modality for about 30 minutes and authomatic capacitive modality for about 10 minutes) and application of Presotherapy (intensity 35%, compression 35seg, pause 15 seg, speed 9, for about 30 minutes). Non-invasive treatment Receives: Other: Experimental group |
| Control or Cavitation | Active comparator | All patients are given a Combined Physiotherapy Protocol (CPP) consisting of: Cavitation (plane electrode for about 30 minutes and focal electrode for about 10 minutes) at 70% intensity and application of Presotherapy (intensity 35%, compression 35seg, pause 15 seg, speed 9, for about 30 minutes). Non-invasive treatment Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in perimeter measures
measuring tape
Measured: At the begining and at the end of the treatment after seven weeks
Secondary outcomes (4)
Changes in body mass index
Calculation of the body mass index
Measured: At the begining and at the end of the treatment after seven weeks
Changes in weight
Weighing machine
Measured: At the begining and at the end of the treatment after seven weeks
Physical activity evaluation
IPAQ questionnaire
Measured: At the begining and at the end of the treatment after seven weeks
Degree of cellulitis
Nürberger and Müller's scale
Measured: At the begining and at the end of the treatment after seven weeks. This scale measures the level of cellulite and takes the values of 0-3, being 0 the value where there is no cellulite and 3 the most serious stage of cellulite.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start20 Oct 2017
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CellulitisStudies 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
- Model description
- Randomized controlled longitudinal experimental study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Carmona Barrientos, University of Cadiz
- Investigators
- Carmona I. Barrientos, Dra, Principal investigator, University of Cadiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474523
- Sponsor's protocol ID
- Fisioterapia Bahía
- Status last verified
- Mar 2020
- First submitted
- 8 Feb 2018
- Last updated
- 13 Mar 2020
- 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 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment
- ClinicalTrials.gov ID
- NCT03474523
- Acronym / sponsor ID
- Fisioterapia Bahía
- Conditions
- Cellulitis
- Keywords
- radio frequency diathermy, cavitation, ultrasound, edemato-fibrosclerotic panniculopathy, cellulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 22 Mar 2018 (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 the present study is to value the effectiveness of Diathermy-Radiofrecuency treatment compared to Cavitation treatment in woman with cellulitis.
Detailed description
The edemato-fibrosclerotic panniculopathy is a segmental disease and lipodystrophy, this disease is localized in subcutaneous connective tissue which is influenced by venous and lymphatic system, when these systems are affected. The secondary vasomotor dysfunction to failure sympathetic nervous system influence on this disease too.
Usually it affects women, influencing their physical and psychological well-being.
The Aesthetic Physiotherapy, known as Aesthetics Plastic and Restorative Physiotherapy, is in their beginnings, there are little studies which present this pathology from the physiotherapy perspective. The investigators believe that their research could make some progress in this matter.
The search found very few clinical trials of scientific rigor about radio frequency and cavitation, and The investigators didn't find studies that compare both. Both treatments show effectiveness in improving the appearance of cellulite, so it would be a good idea compare them and see the most effective.
The investigators are trying to compare the effectiveness of both techniques and the investigators consider innovative and with added value to investigate something that we haven´t found in the reviewed literature.
The investigators choose 20 women randomly, 40 sample subjects, between 18-40 years old. These women must keep the inclusion criteria.
The participants attend a first date where the investigators collect the necessary data, and they are valued before and after the treatment (perimetry, photographic, Nürnberger and Müller scale, weight, height, BMI).
Then each patient receive treatment, seven non-consecutive sessions Diathermy-Radiofrequency on one leg (gluteal zone, internal and lateral zone, posterior and anterior zone) and other 7 sessions of Cavitation in the other leg, and Presotherapy in both legs.
The investigators also advice the participants about their diet and exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled longitudinal experimental study
| Arm | Type | Receives |
|---|---|---|
| Experimental or Diathermy-Radiofrecuency | Experimental | Other: Experimental groupAll patients are given a Combined Physiotherapy Protocol (CPP) consisting of: Diathermy-Radiofrecuency (manual 70% intensity of about 40-43º resistive modality for about 30 minutes and authomatic capacitive modality for about 10 minutes) and application of Presotherapy (intensity 35%, compression 35seg, pause 15 seg, speed 9, for about 30 minutes). Non-invasive treatment |
| Control or Cavitation | Active comparator | Other: Control groupAll patients are given a Combined Physiotherapy Protocol (CPP) consisting of: Cavitation (plane electrode for about 30 minutes and focal electrode for about 10 minutes) at 70% intensity and application of Presotherapy (intensity 35%, compression 35seg, pause 15 seg, speed 9, for about 30 minutes). Non-invasive treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female
- UCA comunity
- Age 18-40 years
- Cellulite grade I, II, III (Nürnberg\&Müller clasification)
- Compliance of study timing
Key exclusion criteria (14 listed)
- Pacemaker, heart diseases, epilepsy,
- pregnancy, lactation, last year postpartum, menstrual cycle alterations, climacteric, perimenopause
- chronic disease, hormonal or circulatory disorder, neoplasia process
- inflammation, infection, active acne, open wound in the treatment area
- BMI above 27 Kg/m2, obesity, lipoedema, oedema, circulatory problems
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 |
|---|---|---|
| Experimental groupCavitation: 70% intensity, 30 minutes apply plane electrode and 10 minutes focal electrode. Presotherapy: 30 minutes application of 35% intensity, compression 35seg, pause 15seg, speed 9 | Other | Experimental or Diathermy-Radiofrecuency |
| Control groupDiathermy-Radiofrecuency: 30 minutes at 70% intensity (40-43ºC) in manual resistive modality and 10 minutes in automatic capacitive modality. Presotherapy: 30 minutes application of 35% intensity, compression 35seg, pause 15seg, speed 9 | Other | Control or Cavitation |
Primary outcome
Decrease in perimeter measures
Time frame: At the begining and at the end of the treatment after seven weeks
measuring tape
4 secondary outcomes
Changes in body mass index
Time frame: At the begining and at the end of the treatment after seven weeks
Changes in weight
Time frame: At the begining and at the end of the treatment after seven weeks
Physical activity evaluation
Time frame: At the begining and at the end of the treatment after seven weeks
Degree of cellulitis
Time frame: At the begining and at the end of the treatment after seven weeks. This scale measures the level of cellulite and takes the values of 0-3, being 0 the value where there is no cellulite and 3 the most serious stage of cellulite.
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 13 Mar 2020.
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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.
Carmona I. Barrientos, Dra principal investigator
University of Cadiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Cellulitis, run by University of Cadiz 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 6 inclusion and 14 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 13 Mar 2020. 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. 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?
Decrease in perimeter measures (time frame: At the begining and at the end of the treatment after seven weeks). 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 13 Mar 2020.