Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment

The aim of the present study is to value the effectiveness of Diathermy-Radiofrecuency treatment compared to Cavitation treatment in woman with cellulitis.

Study Overview

• Status: Completed
• Conditions: Cellulitis
• Intervention / Treatment: Other: Experimental group; Other: Control group

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cádiz, Spain, 11008
    • Faculty of Nursing and Physiotherapy. University of Cadiz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in perimeter measures	measuring tape	At the begining and at the end of the treatment after seven weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body mass index	Calculation of the body mass index	At the begining and at the end of the treatment after seven weeks
Changes in weight	Weighing machine	At the begining and at the end of the treatment after seven weeks
Physical activity evaluation	IPAQ questionnaire	At the begining and at the end of the treatment after seven weeks
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.

Collaborators and Investigators

• Sponsor: University of Cadiz
• Investigators: Principal Investigator: Carmona I. Barrientos, Dra, University of Cádiz

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Actual): March 11, 2020
• Study Completion (Actual): March 11, 2020

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: ultrasound; cellulitis; radio frequency diathermy; cavitation; edemato-fibrosclerotic panniculopathy
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Wounds and Injuries; Connective Tissue Diseases; Skin Diseases, Infectious; Suppuration; Body Temperature Changes; Heat Stress Disorders; Cellulitis; Hyperthermia
• Other Study ID Numbers: Fisioterapia Bahía

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No