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.: PACTR202201692514537 Date of Approval: 06/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title kinesiotaping for knee osteoarthritis
Official scientific title Effects of Combined Taping of Quadriceps and Hamstring Muscles on Pain and Disability in Patients with Knee Osteoarthritis: Randomized Controlled Study
Brief summary describing the background and objectives of the trial Maintaining the daily living activities in patients suffering from chronic knee osteoarthritis without pain or discomfort is a valuable target. Purpose: This study aimed to assess the effect of quadriceps and hamstring muscles taping using kinesio tape as a cheap noninvasive technique on knee pain, range of motion (ROM) and functional disability in patients with chronic knee osteoarthritis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 08/01/2022
Actual trial start date
Anticipated date of last follow up 08/03/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants) 24
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group conventional exercises only three times per week four weeks The exercise program included hamstring and calf muscles stretching exercises and quadriceps muscles strengthening exercises. 12 Active-Treatment of Control Group
Experimental Group kinesio tape application on quadriceps and hamstring muscles in addition to conventional exercises three times per week four weeks Taping procedure involved the application of three taping strips (superior Y, inferior Y, and U strip techniques) on the front of the knee region for quadriceps muscle and one strip (superior Y technique) on the thigh back for the hamstring muscles. The exercise program included hamstring and calf muscles stretching exercises and quadriceps muscles strengthening exercises. 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients with age of 50- 70 years old patients are diagnosed as chronic knee OA at third degree as determined by Kellgren/Lawrence grading system history of joint replacement rheumatoid arthritis steroid injection or knee surgery in the previous six months acute inflammation around knee joint infection or systemic disease of musculoskeletal system underlying disease such as malignancy. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 70 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 12/09/2020 ethical committee of faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
7Ahmed Ezzayat Bien Essarayat Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain and functional disability pre and post four weeks of treatment
Secondary Outcome knee flexion range of motion pre and post four weeks of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy 7Ahmed Ezzayat street Bien Essarayat Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Reda Sayed Ashour 7 Ahmed Ezzayat Street Bien Essarayat Giza 12612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Cairo university street, Giza, Egypt Cairo 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dina Samy Abd Alkareem 7Ahmed Ezzayat Bien Essarayat Giza 12612 Egypt
Alaa Eldin Abd Alhakem Balbaa 7Ahmed Ezzayat Bien Essarayat Giza 12612 Egypt
Magdolin Mishel samy 7Ahmed Ezzayat Bien Esssarayat Giza 12612 Egypt
Yassmin Essam Mohamed 7Ahmed Ezzayat Bien Essarayat Giza 12612 Egypt
Reda sayed Ashour 7ahmed Ezzayat Bien Essarayat Giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Reda Ashour reda.sayed@pt.cu.edu.eg 00236717691 7Ahmed Ezzayat Bien Essarayat
City Postal code Country Position/Affiliation
Giza 12612 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Yassmin Mohamed dryassminessam@gmail.com 00236717691 7Ahmed Ezzayat Bien Essarayat
City Postal code Country Position/Affiliation
Giza 12612 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Reda Ashour reda.sayed@pt.cu.edu.eg 00236717691 7Ahmed Ezzayat Bien Essarayat
City Postal code Country Position/Affiliation
Giza 12612 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures) will be available Study Protocol beginning 12 months and ending 36 months following article publication anyone who wishes to access the data for any purpose
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