Effectiveness of Diathermy-Radiofrecuency Compared With Cavitation in Cellulitis Treatment

NCT03474523 | Completed

• 1 other identifier: Fisioterapia Bahía
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cellulitis

Keywords

radio frequency diathermy; cavitation; ultrasound; edemato-fibrosclerotic panniculopathy; cellulitis

Outcome Measures

Primary Outcomes (1)

• Decrease in perimeter measures

  measuring tape

  At the begining and at the end of the treatment after seven weeks

Secondary Outcomes (4)

• Changes in body mass index

  At the begining and at the end of the treatment after seven weeks

• Changes in weight

  At the begining and at the end of the treatment after seven weeks

• Physical activity evaluation

  At the begining and at the end of the treatment after seven weeks

• Degree of cellulitis

  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.

Study Arms (2)

Experimental or Diathermy-Radiofrecuency

EXPERIMENTAL

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

Control or Cavitation

ACTIVE COMPARATOR

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

Interventions

Experimental group 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

Experimental or Diathermy-Radiofrecuency

Control group 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

Control or Cavitation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: PEFE has a greater incidence within women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cadiz: lead

Study Sites (1)

Faculty of Nursing and Physiotherapy. University of Cadiz

Cadiz, 11008, Spain

Location

MeSH Terms

Conditions

Cellulitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Carmona I. Barrientos, Dra

  University of Cadiz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: external evaluator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled longitudinal experimental study

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: March 22, 2018
• Study Start: October 20, 2017
• Primary Completion: March 11, 2020
• Study Completion: March 11, 2020
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

ES (1)