An interventional study of Experimental group and Control group in Cellulitis, sponsored by University of Cadiz. Completed at 1 site in Spain. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-13.
Sponsored by University of Cadiz · Not applicable, Interventional, and Treatment
The aim of the present study is to value the effectiveness of Diathermy-Radiofrecuency treatment compared to Cavitation treatment in woman with cellulitis.
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.
160 studies on the registry are indexed under Cellulitis; 14 are open to participants now.
This study's enrollment of 40 is below the median of 157 across 124 interventional studies indexed under Cellulitis.
Browse Cellulitis studies →University of Cadiz is the lead sponsor of 55 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Experimental group
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
Other: Control group
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
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
Decrease in perimeter measures
measuring tape
Time frame: At the begining and at the end of the treatment after seven weeks
Changes in body mass index
Calculation of the body mass index
Time frame: At the begining and at the end of the treatment after seven weeks
Changes in weight
Weighing machine
Time frame: At the begining and at the end of the treatment after seven weeks
Physical activity evaluation
IPAQ questionnaire
Time frame: At the begining and at the end of the treatment after seven weeks
Degree of cellulitis
Nürberger and Müller's scale
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.
Ran from Oct 2017 to primary completion in Mar 2020, 28 months.
Of 18 interventional studies with no phase under Cellulitis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's 28 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Cadiz