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.: PACTR201910510244005 Date of Approval: 07/10/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison Among Effect of McConnell Tape, Kinesiology Tape and Open Knee Brace in Treatment of Patellofemoral Pain
Official scientific title Comparison Among Effect of McConnell Tape, Kinesiology Tape and Open Knee Brace in Treatment of Patellofemoral Pain
Brief summary describing the background and objectives of the trial Patellofemoral pain syndrome (PFPS) is a condition presenting with anterior knee pain or pain behind the patella (retro-patellar pain).The incidence in the general population is 25% in adolescents and adults. Incidence rates vary from 22 new cases per 1000 persons/year in highly active populations to 5 to 6 new cases per 1000 in general practice. Techniques using Kinesio Tape (KT) has become increasingly popular; however, there has been scant research supporting its use on patients with PFPS. Kinesio taping can reduce pain and increase the muscular flexibility of PFPS patients, Kinesio taping technique used for muscles can relieve pain but cannot change patellar alignment, Although there are many studies including the use of electrostimulation, sufficient data does not exist on the effects of KT use in patients with PFPS. A study investigated the bioelectric effect of KT on the vastus medialis muscle. It showed that muscle bioelectrical activity increased 24 hours after taping and continued for 48 hours after the tape was removed. McConnell introduced a rehabilitation program that incorporates patellar-taping techniques to improve patellar tracking within the patellofemoral groove, as well as lateral knee structure stretching, VMO strengthening, and closed kinematic chain training. The McConnell patellar taping (MT) is intended to correct patellar tracking by medialising the patella, allowing patients to engage in pain-free physical therapy exercises.There have been numerous reports about the use of knee braces to prevent traumatic knee injuries. Despite the frequent use of braces, very few prospective studies have been performed to study the effect of knee braces for preventing PFPS. The use of patellofemoral braces improves subjectively the knee stability and pain perceptionin patellofemoral patients, but they could not demonstrate any objective effect.Upon available knowledge, there are gap of knowledge in assessment and comparing the effect of the most three popular forms of patellar support in the physical therapy.in this study we need to know which is more effective McConnell tape ,Kinesio tape or open knee brace in improving patellofemoral pain, range of motion and functional activities.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/11/2018
Actual trial start date 01/10/2018
Anticipated date of last follow up 01/11/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants)
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 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 open knee brace Three times per week Six weeks Open knee brace beside physical therapy ( electro therapy interferential current - hot pack- patellar mobilization and strengthening exercises. 16 Active-Treatment of Control Group
Experimental Group McConnell taping three times per week Six weeks Mcconnell taping beside The traditional physical therapy program, which includes interferential therapy (Fuentes, 2010) patellar mobilization (Stakes et al., 2006) (Rowlands & Brantingham,1999), quadriceps-strengthening exercise, 16
Experimental Group kinesiology taping three times per week Six weeks Kinesiology taping beside The traditional physical therapy program, which includes interferential therapy (Fuentes, 2010) patellar mobilization , quadriceps-strengthening exercise, 16
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-The patient age 20 to 40 years old from both sexes . -The body mass index(BMI) of the patients ranged between 23 - 31Kg/ m2. -The patients will be diagnosed and referred by orthopedist as patellofemoral syndrome -The diagnosis will be confirmed by knee x-ray three views (anterior – posterior, Axial, sagittal view) or knee MRI. - Anterior knee pain in one or both knees -inclusion requirement included two or more of the following pain complaints: 1. ascending/descending stairs 2. Squatting 3. Sitting with knee bent greater than 15 minutes 4. running, jumping, or hopping - Meniscal injury(medial – lateral) -Osteoarthritis Knee joint -Previous patellar dislocation or subluxation -Previous fractures with or without internal fixation in the knee region  -Any previous knee surgery ( ACL reconstruction or mensectomy)  -Patellar tendon pathology -Any lower limb deformities changing the global alignment  Referred pain from the spine Adult: 19 Year-44 Year 20 Year(s) 40 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 04/11/2018 faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District, Cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome TheAnterior Knee Pain scale (Kujala) three weeks after beging the treatment and after treatment termination
Secondary Outcome measuring Active Range of Motion of The Knee Joint three weeks after the starting the treatment and after the treatment termination
Secondary Outcome Visual Analogue Scale three weeks after the treatment starting and after the treatment termination
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Menshaw hospital El baher street Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
engy Fares adly 8 Abdullah ebn masood st Tanta 31511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor El Menshaw hospital El baher street Tanta 31511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Peter Ramzy naguib 8 Abdullah ebn masood Tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator engy Fares www.engyfaresadly@gmail.com 0201227002927 8 Abdullah ebn masood
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Physical therapist
Role Name Email Phone Street address
Scientific Enquiries abeer abd El rahman Abeer.yamany@pt.cu.edu.eg 0201006899872 alagoza
City Postal code Country Position/Affiliation
Cairo 12654 Egypt professor of physical therapist
Role Name Email Phone Street address
Public Enquiries Nabil mahmoud Nabil.mahmoud@cu.edu.eg 0201200133613 opera city compound, sheikh Zayed
City Postal code Country Position/Affiliation
Giza Egypt lecturer of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Age -sex-BMl - Anterior knee pain scale score (kujala)- Knee Active Range of Motion measurements -visual Analogue Scale score Statistical Analysis Plan,Study Protocol 3months Patellofemoral pain
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