Clinical trial NCT03474523: Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment
Official title: Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cellulitis
Keywords: radio frequency diathermy
cavitation
ultrasound
edemato-fibrosclerotic panniculopathy
cellulitis
Lead sponsor: University of Cadiz
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled longitudinal experimental study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decrease in perimeter measures
timeFrame: At the begining and at the end of the treatment after seven weeks
Secondary outcomes:
measure: Changes in body mass index
timeFrame: At the begining and at the end of the treatment after seven weeks
measure: Changes in weight
timeFrame: At the begining and at the end of the treatment after seven weeks
measure: Physical activity evaluation
timeFrame: At the begining and at the end of the treatment after seven weeks
measure: Degree of cellulitis
timeFrame: 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.
Other outcomes:
Locations:
city: Cádiz
country: Spain
facility: Faculty of Nursing and Physiotherapy. University of Cadiz
Study officials:
affiliation: University of Cadiz
name: Carmona I. Barrientos, Dra
role: PRINCIPAL_INVESTIGATOR
References: