Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment

Cellulitis Clinical Trial

Official title:

Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474523
• Other study ID #: Fisioterapia Bahía
• Status: Completed
• Phase: N/A
• Start date: October 20, 2017
• Est. completion date: March 11, 2020

Study information

• Verified date: March 2020
• Source: University of Cadiz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cellulitis

Intervention

Other:
• Experimental 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
• Control 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

Locations

Country	Name	City	State
Spain	Faculty of Nursing and Physiotherapy. University of Cadiz	Cádiz

Sponsors (1)

Lead Sponsor	Collaborator
University of Cadiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in perimeter measures	measuring tape	At the begining and at the end of the treatment after seven weeks
Secondary	Changes in body mass index	Calculation of the body mass index	At the begining and at the end of the treatment after seven weeks
Secondary	Changes in weight	Weighing machine	At the begining and at the end of the treatment after seven weeks
Secondary	Physical activity evaluation	IPAQ questionnaire	At the begining and at the end of the treatment after seven weeks
Secondary	Degree of cellulitis	Nürberger and Müller's scale	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.