Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201902473450574 Date of Approval: 04/02/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Caffeine phonophoresis versus shock wave therapy for adult females with cellulite
Official scientific title Caffeine phonophoresis versus shock wave therapy for adult females with cellulite: A randomized controlled trial
Brief summary describing the background and objectives of the trial Caffeine phonophoresis versus shock wave therapy for adult females with cellulite: A randomized controlled trial. Background: Cellulite is a widespread problem involving females' buttocks and thighs (85% of post-adolescent women). It is characterized by an irregular, dimpled skin surface with thinning of the epidermis/dermis and presence of nodular clusters of fat cells. Caffeine has anticellulite effect due to its lipolytic activity in fatty cells. Moreover, shock wave therapy treats cellulite through improvement of cell permeability. Objective: To compare between the effects of caffeine phonophoresis and shock wave therapy in the treatment of female with cellulite.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 27/01/2019
Actual trial start date 27/01/2019
Anticipated date of last follow up 14/04/2019
Actual Last follow-up date 14/04/2019
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 40
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group caffeine phonophoresis caffeine 5% gel phonophoresis with an intensity of 0.2W/cm2 at a rate of 1 min/cm2, 3 times/week 4 weeks The caffeine phonophoresis group will receive caffeine 5% gel phonophoresis 3 times/week. The affected area will be cleaned with cotton soaked with alcohol for sterilization. The ultrasound device (ULS-1000, Taiwan). The equipment will be set and calibrate for a frequency of 3 MHz,31 and an intensity of 0.2 W/cm2 at a rate of 1 min/cm2, with continuous emission.32 An application time of 1 min/cm2 was used,33 with the transducer will be moved slowly and continuously until the end of the application.16 The caffeine gel will be prepared by adding 5% (w/w) of anhydrous caffeine (Sigma Chemical Company, St. Louis, MO, USA) to the gel. 20 Active-Treatment of Control Group
Experimental Group shock wave therapy shock wave therapy for 2 times/week 4 weeks The shock wave equipment (developed by STORZ medical AG, Swiss) with D-Actor applicator (radial waves) and energy levels (0.1-8.0) with mean energy level 3.5 was used. This level corresponds to an energy flux density of 0.16 mJ/mm2. The treatment region was scanned with 2000 shots using D-actor applicator in both horizontal (1000 shots) and vertical (1000 shots) directions for 15 minutes. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female patients with bilateral cellulite (grades 2 and 3) at their thighs, non-pregnant females, free from any pathological condition that might affect the results, received a good explanation of treatment and measurement devices age under 30 or above 45 years, breastfeeding, diseases of the skin, thrombosis or post-thrombosis syndrome, known malginoma or chemotherapy, anti-coagulation therapy, cortisone- therapy, known metabolic disorders (ie, diabetes mellitus hyper-cholesterinemia etc.), inflammation within the treatment area, other simultaneous treatment of cellulite, morbid obesity (BMI >40). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/12/2018 Research ethical committee of faculty of physical therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
Faculty of Physical Therapy, Cairo University, 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki, Giza. Giza 12611 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Skin fold thickness pre and post 4 weeks of treatment
Secondary Outcome Cellulite grade pre and post 4 weeks of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Out patients clinics of faculty of physical therapy Cairo University Faculty of Physical Therapy, Cairo University, 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki, Giza, Egypt. Giza 12611 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The authors of the article 7 Ahmed Elzaiat St. Ben Elsaryat, El-Dokki Giza 12611 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Faculty of physical therapy 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki, Giza 12611 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abdel aziem AA 7 Ahmed Elzaiat St. Ben Elsaryat, El-Dokki Giza 12611 Egypt
Ashem HN 7 Ahmed Elzaiat St. Ben Elsaryat, El-Dokki giza 12611 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amira Draz amira.draz@pt.cu.edu.eg +201149411373 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki
City Postal code Country Position/Affiliation
Giza 12611 Egypt Assistant professor of physical therapy for basic science
Role Name Email Phone Street address
Public Enquiries Amira Draz amira.draz@pt.cu.edu.eg +201149411373 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki
City Postal code Country Position/Affiliation
Giza 12611 Egypt Assistant professor of physical therapy for basic science
Role Name Email Phone Street address
Scientific Enquiries Amr Abdelaziem amralmaz@yahoo.com +201006229996 7 Ahmed Elziat Street, Ben Elsaryat, El Dokki
City Postal code Country Position/Affiliation
Giza 12611 Egypt Professor of Biomechanics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Change in cellulite grade changes in skin thickness Study Protocol After completion of the study cellulite and skin thickness
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not applicable No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information