Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment

NCT ID: NCT03474523

Last Updated: 2020-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-20

Study Completion Date

2020-03-11

Brief Summary

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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

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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

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Cellulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled longitudinal experimental study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
external evaluator

Study Groups

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Experimental or Diathermy-Radiofrecuency

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

Group Type EXPERIMENTAL

Experimental group

Intervention Type OTHER

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 or Cavitation

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

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Cadiz

OTHER

Sponsor Role lead

Responsible Party

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Ines Carmona Barrientos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carmona I. Barrientos, Dra

Role: PRINCIPAL_INVESTIGATOR

University of Cadiz

Locations

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Faculty of Nursing and Physiotherapy. University of Cadiz

Cadiz, , Spain

Site Status

Countries

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Spain

Other Identifiers

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Fisioterapia Bahía

Identifier Type: -

Identifier Source: org_study_id

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