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.: PACTR201702001948210 Date of Approval: 29/12/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title knee physiotherapy
Official scientific title EFFECT OF KINESIOTAPING VERSUS ISCHEMIC COMPRESSION ON PATELLAR TENDINITIS
Brief summary describing the background and objectives of the trial Patellar tendinitis (patellar tendinopathy, also known as Jumper's knee), Patellar tendinopathy (PT) is one of the most common reasons for pain of the knee. According to Ischemic compression is a continuous perpendicular deep thumb pressure, where blockage of blood in an area of the body is made followed by local blood flow up on release or hyperemia in that region resulting in pain relief. Kinesiotaping is a form of elastic therapeutic tape allows for a longitudinal stretch of its resting length. This elasticity of the tape when applied to the skin, it provides a pulling force to the skin and creates more space by lifting the fascia and soft tissue under the areas where it is applied so the circulation of blood and lymph fluid can be facilitated, and healing rate of tissue can be increased.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EOKVISCONEAOQMIPWPT
Disease(s) or condition(s) being studied Musculoskeletal Diseases,patellar tendinitis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 08/01/2017
Actual trial start date 01/01/2017
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet 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 the patients will be assigned randomly by using blocks of different sizes which will be done by a second person into three groups the allocation will be determined by a third person (the holder of the sequence who is situated off site) Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ischemic copression + traditional program for patellar tndinitis 12 session. session each other day one month rest + ice massage for 10 minutes + ischemic compression for 9 seconds over each trigger point+ strengthening exercises (3 sets for 10 repetitions) + stretching exercises (3 repetitions) 14
Control Group (group 3) traditional program for patellar tendinitis 12 session. session each other day one month Rest + ice massage for 10 minutes + strengthening exercises (3sets for 10 repetitions) + stretching exercises (3 repetitions ( 12
Experimental Group group 1( ischemic compression + traditional physiotherapy program) 12 session. session every each other day one month rest + ice massage for 10 minutes + ischemic compression for 9 seconds over each trigger point+ strengthening exercises (3 sets for 10 repetitions) + stretching exercises (3 repetitions) 14
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Subject¿s age will range from 20 to 35 years old. 2. In the initial clinical examination, the subject will be referred from an orthopedic physician with patellar tendinitis. 3. Subjects will not have undergone application of any physiotherapy or medications to relieve pain. 1. Previous knee surgery 2. Leg length discrepancy 3. Rheumatoid arthritis 4. Knee ligaments injury 5. Osgood-Schlatter Disease 6. Knee osteoarthritis 7. Other neurological, orthopedic conditions 8. Patients with mental disorders make cooperation impossible. 9. Patellar subluxation or dislocation. 10. pregnancy. 20 Year(s) 35 Year(s) Both
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 01/01/2017 faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
Ahmed El Zayad street giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain before treatment after treatment a week following treatment
Primary Outcome quadriceps electrical activity before treatment after treatment a week after treatment
Secondary Outcome balance before treatment after treatment a week after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
the clinic of faculty of Elhawamdya General Hospital cairo Aswan road giza 12612
the clinic of faculty of physical therapy 7 Ahmed ElZayad street, Dooki, Giza, Egypt giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university Tharwat street giza 12612 Egypt University
Primary Sponsor Cairo University Tharwat street giza Egypt University
Secondary Sponsor faculty of physical therapy 7 Ahmed ElZayad street, Dooki, Giza, Egypt giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Haytham Mohamed El Hafez 7 Ahmed Elzayat Street Giza 12612 Egypt
Dalia Mohamed Moasad 7 Ahmed Elzayat Street giza 12612 Egypt
Ahmed Fathy Genedy 7 Ahmed Elzayat Street giza 12612 Egypt
Ghada Esmael Mohamed Kamel 7 Ahmed Elzayat Street giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haytham Elhafez elhafez@yahoo.com 01001909630 7 Ahmed Elzayat Street
City Postal code Country Position/Affiliation
giza 12612 Egypt Professor of Physical Therapy at the basic science department in the faculty of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Dalia Mohamed Mosaad drdaliamosaad@gmail.com 01001909630 7 Ahmed Elzayat Street
City Postal code Country Position/Affiliation
giza 12612 Egypt Assistant professor of Physical Therapy
Role Name Email Phone Street address
Scientific Enquiries Ahmed Fathy Gnedy elhafez@yahoo.com 01001909630 7 Ahmed Elzayat Street
City Postal code Country Position/Affiliation
giza 12612 Egypt Consultant in the Military Medical Academy and director of Agouza Rehabilitation Center
Role Name Email Phone Street address
Scientific Enquiries Ghada Esmael Mohamed Drdody2007@outlook.com 01063770894 7 Ahmed Elzayat Street
City Postal code Country Position/Affiliation
giza 12612 Egypt Lecturer of Physical Therapy
REPORTING
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