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.: PACTR201902658798814 Date of Approval: 04/02/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Kinesiotaping combined with pneumatic compression versus multilayer bandage on post-mastectomy lymphedema
Official scientific title Kinesiotaping combined with pneumatic compression versus multilayer bandage on post-mastectomy lymphedema
Brief summary describing the background and objectives of the trial The breast cancer is the most common cancers among women. Lymphedema is one of the most serious and predominant complication of breast cancer. Lymphedema changes functional abilities and may affect a patient’s psychosocial adjustment and overall quality of life and represents a complex therapeutic challenge for the physician. Problems associated with lymphedema include pain, feeling of discomfort and heaviness, difficulties with physical mobility, physiological distress, recurrent infections and social isolation which all negatively affect the quality of life of the patient Lymphedema is a chronic and progressive condition. It is marked by an abnormal increase of tissue proteins, edema, chronic inflammation, and fibrosis caused by multiple factors related with lymphatic stasis, such as tumor lymph node infiltration, lymph node dissection, radiotherapy, trauma, and infection. Complex decongestive physical (CDP) therapy is known as an international standard approach for lymphedema treatment. These techniques include manual lymphatic drainage (MLD), compression bandaging, exercise, and skin care. The previous studies investigate mainly therapeutic effects of CDP therapy techniques on the changes of extremity size and lymphedema volume Intermittent pneumatic compression (IPC) is often suggested in the field of physical treatment of primary and secondary lymphedema. IPC consists in the application of a force on an edema in order to evacuate its components as much as possible towards the physiological ways of drainage. Kinesiology Taping (KT) for lymphatic drainage is a new choice in the field of physical and alternative therapy. Development of the technique for its administration is still ongoing. Applying KT would have physiological effects including decreasing pain, supporting the movement of muscles, removing congestion of lymphatic fluid or hemorrhages under the skin, and correcting misalignment of joints. Multi-layer bandaging is gradient compression suggests that the pressure over distal parts of the extremity has always to be higher than over proximal parts. By applying two or more layers of elastic material over each other the final bandage change its elastic property, becoming getting more inelastic (stiff) due to the friction between the layers. Bandaging may be very effective in aiding symptom control in patients with cancer-related lymphedema patients with complex medical problems. The compression therapy with low stretch bandages are used, which maintain the effects of the performed manual lymphatic drainage (MLD). Multi-layer bandaging is used during a period of intensive treatment it may also be used as part of long-term management in certain groups who cannot wear compression hosiery. Traditional approaches to multilayer bandaging use inelastic bandages over padding or foam layers
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CDP MLD KT ICP
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/01/2019
Actual trial start date 07/01/2019
Anticipated date of last follow up 01/05/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Kinesiotaping combined with intermittent pneumatic compression in addition to CDP therapy 3 sessions per week four weeks fifteen female will receive K-Taping combined with intermittent pneumatic compression (IPC) in addition to Complex decongestive physical (CDP) therapy by 3 sessions per week for four weeks. 15
Experimental Group Multilayer bandage in addition to CDP therapy 3 sessions per week four weeks fifteen female will receive Multilayer bandage in addition to CDP therapy by 3 sessions per week for four weeks. 15
Control Group CDP therapy 3 sessions per week four weeks fifteen female will receive Complex decongestive physical (CDP) therapy by 3 sessions per week for four weeks 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All patients will be selected from female. • The patients aged will be ranged from 45-60 years old. • BMI between 18.5 – 30 Kg/m2. • Unilateral post-mastectomy upper extremity lymphedema. • Grade I & II severity of lymphedema. • Bilateral upper extremity lymphedema • Congestive heart failure, renal failure, taking anticoagulant drugs. • Having surgery on arm. • Malignant lymphedema, • Infection in the arm, • BMI more than 30 Kg/m2. • Intolerable bandage, skin redness and intense itching as a result of bandages. • The lack of cooperation from the patient. Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 60 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 09/07/2017 Faculty of Physical Therapy
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elziat st Giza 12611 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Volumetric measurement Pre-test, post-test
Primary Outcome Anthropometric Measures of Limb Volume Pre-test, Post-test
Secondary Outcome Lymphedema Breast Cancer Questionnaire Pre-test, Post-test
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Cancer Institute Kasr Al Eini Street, Fom El Khalig Cairo 11796 Egypt
Baheya Hospital 4, Allouba St. off El Haram St. Next to Dary, Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mahmoud Moustafa 108 Tahirier St. Dokki Sq Giza 12611 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Moustafa Aboul Fotouh mahmoud_mpc@outlook.com 01009788883 108 Tahrier St Dokki Sq.
City Postal code Country Position/Affiliation
Giza Egypt Doctor of physical therapy
Role Name Email Phone Street address
Public Enquiries Mohammed ElGendy melgendy@hotmail.com 01005747169 Motamize St
City Postal code Country Position/Affiliation
6th October Egypt Head department
Role Name Email Phone Street address
Scientific Enquiries Rania Karkousha rania.nagy@pt.cu.edu.eg 01227244630 Shobra Masr
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Prof.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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