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Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment

Primary Purpose

Cellulitis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental group
Control group
Sponsored by
University of Cadiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cellulitis focused on measuring radio frequency diathermy, cavitation, ultrasound, edemato-fibrosclerotic panniculopathy, cellulitis

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Nursing and Physiotherapy. University of Cadiz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental or Diathermy-Radiofrecuency

Control or Cavitation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Decrease in perimeter measures
measuring tape

Secondary Outcome Measures

Changes in body mass index
Calculation of the body mass index
Changes in weight
Weighing machine
Physical activity evaluation
IPAQ questionnaire
Degree of cellulitis
Nürberger and Müller's scale

Full Information

First Posted
February 8, 2018
Last Updated
March 12, 2020
Sponsor
University of Cadiz
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1. Study Identification

Unique Protocol Identification Number
NCT03474523
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
March 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cadiz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulitis
Keywords
radio frequency diathermy, cavitation, ultrasound, edemato-fibrosclerotic panniculopathy, cellulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled longitudinal experimental study
Masking
ParticipantOutcomes Assessor
Masking Description
external evaluator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental or Diathermy-Radiofrecuency
Arm Type
Experimental
Arm Description
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
Arm Title
Control or Cavitation
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Experimental group
Intervention Description
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
Intervention Name(s)
Control group
Intervention Description
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
Primary Outcome Measure Information:
Title
Decrease in perimeter measures
Description
measuring tape
Time Frame
At the begining and at the end of the treatment after seven weeks
Secondary Outcome Measure Information:
Title
Changes in body mass index
Description
Calculation of the body mass index
Time Frame
At the begining and at the end of the treatment after seven weeks
Title
Changes in weight
Description
Weighing machine
Time Frame
At the begining and at the end of the treatment after seven weeks
Title
Physical activity evaluation
Description
IPAQ questionnaire
Time Frame
At the begining and at the end of the treatment after seven weeks
Title
Degree of cellulitis
Description
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.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
PEFE has a greater incidence within women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmona I. Barrientos, Dra
Organizational Affiliation
University of Cadiz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Nursing and Physiotherapy. University of Cadiz
City
Cádiz
ZIP/Postal Code
11008
Country
Spain

12. IPD Sharing Statement

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Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment

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