Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001282471
Ethics application status
Approved
Date submitted
11/07/2016
Date registered
12/09/2016
Date last updated
12/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of monopolar capacitive diathermy by radiofrequency, in stactic application, on cellulite and perimeters reduction of gluteal and posterior thigh areas.
Scientific title
The efficacy of monopolar capacitive diathermy by radiofrequency, in local static application versus local plus segmentary static application, on cellulite and perimeters reduction of gluteal and posterior thigh areas in women.
Secondary ID [1] 289617 0
NONE
Universal Trial Number (UTN)
U1111-1181-5397
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cellulite 299400 0
body circumferences 299401 0
Condition category
Condition code
Skin 299382 299382 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this split leg study, the interventional lower limb received local monopolar capacitive diathermy by radiofrequency in static application, administered by a a physiotherapist with more than ten years of experience. The whole treatment consisted of 20 sessions, at the rate of two sessions weekly, never on consecutive days.
At the start of each session, the initial temperature was recorded by means an infrared thermometer, and the electrodes were placed in a coplanar position in order to cause heating of superficial tissues (adipose, connective, and vascular). The passive electrode was placed transversal to the longitudinal axis of the lower limb on the middle third of the buttock. The active electrode was placed longitudinal to the axis on the outer face of the upper third of the thigh. The electrodes were held in place by 3 elastic straps for stability and uniform contact.
After positioning the electrodes, intensity was raised to 60 dosage units (36 A/min). The sensation perceived by the subject always had to be one of comfortable warmth, which reflected moderate heating of the tissues, and hence the criterion for the dosage of the intensity was the warming sensation reported by the subject. When this sensation exceeded pleasant warmth, the intensity was reduced by 10 units (6 A/min), and when the subject became accustomed to the sensation and reported feeling less warmth than that necessary, the intensity was increased by 10 units.
The temperature was monitored using an infrared thermometer with ISO-CAL-IR calibration certification. Measurements were made during each session at minutes 0, 5, 10, 15, and 20, and whenever the subject requested a change in the intensity. The target range for the temperature was from 40 to 42 Celsius degrees under the active electrode for at least 12 minutes. When the temperature exceeded 44 Celsius degrees, intensity was reduced by 10 dosage units in order to avoid cell damage, even when the subject had not requested such reduction.
Each application lasted 30 minutes. At the end of each session, the temperature was recorded, and the intensity was noted to serve as the initial setting for the next session.
Intervention code [1] 295226 0
Treatment: Devices
Comparator / control treatment
The control lower limb received local plus whole-segment monopolar capacitive diathermy by radiofrequency in static application, administered by a a physiotherapist with more than ten years of experience. The whole treatment consisted of 20 sessions, at the rate of two sessions weekly, never on consecutive days.

Initially, the same procedure was followed as for the local treatment:
Treatment of the lower limb that received local monopolar capacitive diathermy by radiofrequency in static application.
At the start of each session, the initial temperature was recorded by means an infrared thermometer, and the electrodes were placed in a coplanar position in order to cause heating of superficial tissues (adipose, connective, and vascular). The passive electrode was placed transversal to the longitudinal axis of the lower limb on the middle third of the buttock. The active electrode was placed longitudinal to the axis on the outer face of the upper third of the thigh. The electrodes were held in place by 3 elastic straps for stability and uniform contact.
After positioning the electrodes, intensity was raised to 60 dosage units (36 A/min). The sensation perceived by the subject always had to be one of comfortable warmth, which reflected moderate heating of the tissues, and hence the criterion for the dosage of the intensity was the warming sensation reported by the subject. When this sensation exceeded pleasant warmth, the intensity was reduced by 10 units (6 A/min), and when the subject became accustomed to the sensation and reported feeling less warmth than that necessary, the intensity was increased by 10 units.
The temperature was monitored using an infrared thermometer with ISO-CAL-IR calibration certification. Measurements were made during each session at minutes 0, 5, 10, 15, and 20, and whenever the subject requested a change in the intensity. The target range for the temperature was from 40 to 42 Celsius degrees under the active electrode for at least 12 minutes. When the temperature exceeded 44 Celsius degrees, intensity was reduced by 10 dosage units in order to avoid cell damage, even when the subject had not requested such reduction.
Each application lasted 30 minutes. At the end of each session, the temperature was recorded, and the intensity was noted to serve as the initial setting for the next session.

After this local application, a procedure involving whole-segment action of the monopolar capacitive diathermy by radiofrequency in static application was applied, placing the electrodes longitudinally to accentuate the diathermal action on the vascular component. To this end, the active electrode was placed on the sole of the foot, and the passive electrode was placed transversally on the ipsilateral lumbar zone. The intensity was maintained constantly throughout the sessions (60 dosage units) except for one subject, who referred to a burning sensation on the sole of her foot, for whom the intensity used was 50 units. This application lasted 20 minutes.
Control group
Active

Outcomes
Primary outcome [1] 298851 0
Overall Cellulite Severity Scale score, with values between 0 (best score) and 15 (worst score) and its 5 dimensions: number of evident depressions; depth of depressions; morphological appearance of skin surface alterations; grade of laxity, flaccidity or sagging skin; classification scale originally described by Nurnberger and Muller. These five dimensions are each scored from 0 (best score) to 3 (worst score).
Timepoint [1] 298851 0
The evaluation was performed at the beginning (pre-test), midway through (after session number ten) (post-test_1), at the end (post-test_2) of the whole treatment, and after two weeks (post-test_3) and one month (post-test_4) from treatment´s end.
Primary outcome [2] 298852 0
Body circumferences assessed by a tape measure:
- at the upper edge of both iliac crests
- at the most anterior point of the both anterior superior iliac spines
- at the upper pole of the greater trochanter of both femurs.
- at 15, 20, 30 and 40 cm. of the anterior superior iliac spine in a line linking it with the upper pole of the patella
Timepoint [2] 298852 0
The evaluation was performed at the beginning (pre-test), midway through (after session number ten) (post-test_1), at the end (post-test_2) of the whole treatment, and after two weeks (post-test_3) and one month (post-test_4) from treatment´s end.
Secondary outcome [1] 325445 0
Body Mass Index (BMI) was calculated from the results obtained in the measurement of weight and height according to the formula: BMI = weight(kg)/height(m)2.
Timepoint [1] 325445 0
The evaluation was performed at the beginning (pre-test), midway through (after session number ten) (post-test_1), at the end (post-test_2) of the whole treatment, and after two weeks (post-test_3) and one month (post-test_4) from treatment´s end.
Secondary outcome [2] 325446 0
Temperature recorded by an infrared thermometer under the active electrode on the buttock in local application.
Timepoint [2] 325446 0
The temperature was recorded:
- at the start of each session (initial temperature)
- at the end of each session (final temperature)
- when the subject experienced it as too hot (excessive temperature)
- when the subject experienced it as insufficiently warm (insufficient temperature).
Secondary outcome [3] 325447 0
The concern about body shape and body dissatisfaction measured with the Body Shape Questionnaire (Spanish version)
Timepoint [3] 325447 0
The evaluation was performed at the beginning (pre-test), midway through (after session number ten) (post-test_1), at the end (post-test_2) of the whole treatment, and after two weeks (post-test_3) and one month (post-test_4) from treatment´s end.
Secondary outcome [4] 325449 0
Quality of life in skin disease measured by the Skindex-29 (Spanish version)
Timepoint [4] 325449 0
The evaluation was performed at the beginning (pre-test), midway through (after session number ten) (post-test_1), at the end (post-test_2) of the whole treatment, and after two weeks (post-test_3) and one month (post-test_4) from treatment´s end.

Eligibility
Key inclusion criteria
Woman
Age between 18 and 40 years.
Cellulite grade I, II, III (Nurnberger & Muller classification) in buttocks and posterior thighs
Constant dietary habits and physical activity during the study
Accepting the terms and schedule of the experiment
Giving informed consent for the use of the data for research purposes
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pacemaker
Epilepsy
Pregnancy, breastfeeding, or post-partum in the last year
Changes in menstrual cycle, menopause or peri-menopause
Chronic illness, hormonal or coagulation disorder
Cancer
Inflammation, infection, or open wound in the treatment area
Obesity, lipedema, significant edema or circulatory disorders
Metal implants or intrauterine device
Weight fluctuations of more than two kilos in the last 6 months
Drinking more than two alcoholic drinks a day
Drug treatment, in particular, anti-inflammatory, esthetic, cosmetic, or dietary, simultaneous with the study
Treatment of the zones under study in the previous 12 months
Surgery involving the zones under study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each lower limb was assigned to one of the groups by simple random choice, with a blind allocation sequence using black sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with a blind allocation sequence using black sealed envelopes, which were shuffled manually.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. The sample size was calculated based on a pilot study using the program GPower 3.1.3 with the following input data: standardized mean difference 0.54; a-error 0.05; beta-error 0.01; one-tailed hypothesis. The result was n=54 LL, and hence 27 female patients were recruited for the study.
2. Inter-observer reliability: Cronbach's a model of internal consistency, and the Intra-class Correlation Coefficient (ICC).
3. Descriptive analysis of the variables.
4. Since the variables did not follow a normal distribution, non-parametric tests were applied to determine whether there were significant differences over the course of each treatment, and between the two treatments.
5. A repeated measures analysis (ANOVA) with Simple and Helmert tests was applied to determine the impact of treatments on the measurements.
6. The test of Spearman’s rank correlation coefficient was performed in order to determine whether a relationship exists between a loss in body weight and the reduction of cellulite in the gluteofemoral zone.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/04/2010
Date of last participant enrolment
Anticipated
Actual
18/04/2011
Date of last data collection
Anticipated
28/07/2011
Actual
28/07/2011
Sample size
Target
27
Accrual to date
Final
27
Recruitment outside Australia
Country [1] 8016 0
Spain
State/province [1] 8016 0
Seville

Funding & Sponsors
Funding source category [1] 294009 0
University
Name [1] 294009 0
University of Seville
Country [1] 294009 0
Spain
Primary sponsor type
Individual
Name
Maria de la Casa Almeida
Address
University of Seville
c/ Avicena s/n 41009 Seville
Country
Spain
Secondary sponsor category [1] 292824 0
None
Name [1] 292824 0
Address [1] 292824 0
Country [1] 292824 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295417 0
Ethics committee of the University of Seville
Ethics committee address [1] 295417 0
Ethics committee country [1] 295417 0
Spain
Date submitted for ethics approval [1] 295417 0
25/01/2010
Approval date [1] 295417 0
02/02/2010
Ethics approval number [1] 295417 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 952 952 0 0
/AnzctrAttachments/371037-Positive report of the Ethics Committee of the University of Seville.pdf

Contacts
Principal investigator
Name 67206 0
Prof Maria de la Casa Almeida
Address 67206 0
Facultad de Enfermeria, Fisioterapia y Podologia. Centro Docente de Fisioterapia y Podologia. University of Seville.
Calle Avicena s/n, 41009 Seville
Country 67206 0
Spain
Phone 67206 0
+34 654217360
Fax 67206 0
Email 67206 0
[email protected]
Contact person for public queries
Name 67207 0
Maria de la Casa Almeida
Address 67207 0
Facultad de Enfermeria, Fisioterapia y Podologia. Centro Docente de Fisioterapia y Podologia. University of Seville.
Calle Avicena s/n, 41009 Seville
Country 67207 0
Spain
Phone 67207 0
+34 654217360
Fax 67207 0
Email 67207 0
[email protected]
Contact person for scientific queries
Name 67208 0
Maria de la Casa Almeida
Address 67208 0
Facultad de Enfermeria, Fisioterapia y Podologia. Centro Docente de Fisioterapia y Podologia. University of Seville.
Calle Avicena s/n, 41009 Seville
Country 67208 0
Spain
Phone 67208 0
+34 654217360
Fax 67208 0
Email 67208 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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