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Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment

Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03474523
Enrollment
40
Registered
2018-03-22
Start date
2017-10-20
Completion date
2020-03-11
Last updated
2020-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cellulitis

Keywords

radio frequency diathermy, cavitation, ultrasound, edemato-fibrosclerotic panniculopathy, cellulitis

Brief summary

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.

Interventions

OTHERExperimental 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

OTHERControl group

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

Sponsors

University of Cadiz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

external evaluator

Intervention model description

Randomized controlled longitudinal experimental study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Decrease in perimeter measuresAt the begining and at the end of the treatment after seven weeksmeasuring tape

Secondary

MeasureTime frameDescription
Changes in body mass indexAt the begining and at the end of the treatment after seven weeksCalculation of the body mass index
Changes in weightAt the begining and at the end of the treatment after seven weeksWeighing machine
Physical activity evaluationAt the begining and at the end of the treatment after seven weeksIPAQ questionnaire
Degree of cellulitisAt 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.Nürberger and Müller's scale

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026