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.: PACTR201906789887048 Date of Approval: 24/06/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of low level laser therapy on knee range of motion and functional abilities after total knee arthroplasty
Official scientific title Effect of Low Level Laser Therapy on Knee Range of Motion and Functional Abilities after Total Knee Arthroplasty
Brief summary describing the background and objectives of the trial The present study is conducted to determine the effectiveness of Low level Laser therapy on knee range of motion and functional abilities after total knee arthroplasty. Osteoarthritis of the knee is considered the most common orthopedic problem and when it becomes severe, total knee arthroplasty is the recommended solution. If the patients cannot participate in the training and perform the activities of daily living after TKR, their qualities of life would be affected. Finally, it will increase the suffering of patient and affect the length of convalescence so that, adequate pain management and controlling localized swelling are necessary and important. Despite the influence of knee swelling on the rehabilitation process, little researches have been conducted on functional abilities of daily living on patients with TKA. So that, this study was applied to fill this gap of knowledge and find an optimum rehabilitation strategy reaching by patients with TKA to maximum level of independence in their activities of daily living.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TKA
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 30/06/2019
Actual trial start date 30/06/2019
Anticipated date of last follow up 14/12/2020
Actual Last follow-up date 14/12/2020
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
012002218 Research Ethical Committee of Faculty of Physical therapy Cairo university
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 Numbered containers Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A These procedures were applied until complete the (12) treatment sessions in 6 weeks, each session lasted for 60-90 minutes. 6 weeks as two sessions per week Low level Laser therapy besides intensive functional rehabilitation program (mofee et al., 2004) Twenty (20) subjects received a laser dose of 6 J/cm2 over 8 points around the knee, the selected points were the surgical incision, medial and lateral femoral condyle, patellar up and down, and popliteal space (Youssef et al., 2016). Laser therapy was administered at a low power (continuous wave, wavelength 650 nm), 60 seconds per point with a total dose of 48J in each session (Xu et al., 2017), beside the intensive functional rehabilitation program which include 12 sessions in 6 weeks, 60-90 minutes each in form of warm up (5-10mins): lower limb flexion /extension, alternate ankle dorsiflexion-plantarflexion, hamstring stretch. Specific strength exercises (15mins): isometric knee extension in 00 and 600 flexion at visit (1-2); isometric hamstrings 600 flexion at visits (3-6): concentric eccentric hip abductors against gravity at visits (1-4). Functional task-oriented exercises (15-20 mins): get up- sit down, knee extensor strengthening in standing with thera band at visits (1-6); controlled bilateral knee flexion-extension in standing at visits (1-8); unilateral knee flexion to 900 in standing at visits (7-10); climbing stairs and walk laterally while crossing lower limbs at visits (3-12): walk in place with large amplitude hip and knee flexion with upper limb movements at visits (9-12). Endurance exercises (15-20 mins): walk at visits (3-12), bike exercise at visits (4-12). Cool down (10 mins), slow walk and ice application (Moffet et al., 2004). 20
Control Group Group B Group B (control group): Twenty (20) subjects received only the intensive functional rehabilitation program (Moffet et al., 2004). 6 weeks by two sessions per week Only receives intensive functional rehabilitation program (mofee et al., 2004) 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: 1. 50 to 70 years old. 2. Patients with a diagnosis of knee osteoarthritis symptoms and surgical indications. 3. Patients underwent first total knee replacement. 4. All patients have the same operation method, normal blood clotting index. 5. Conscious and without cognitive impairment. 6. No other medical conditions other than an osteoarthritis; have no risk of falling and can ambulate after surgery; have no paralysis of central or peripheral nerves; and have no inflammation or side effects (Seung-Keun et al., 2014). 7. Not more than 2 weeks after TKA. Exclusion criteria: 1. Patients with serious cardiovascular disease, neurological disease, osteoporosis and metabolic disease. 2. Hemophilic patients, sever diabetic patients, tumor, or patients with coagulative disorder. 3. Patients with fracture or dislocation or any other surgeries. 4. Patients who had not signed the informed consent form were automatically be excluded from this study. 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 03/02/2019 Research Ethical Committee at Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
El-Tahrir St. in front of Ben El-Sarayat Traffic- Dokki- Giza Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome This study will be conducted to investigate the effect of low level laser therapy on the following: 1. Pain intensity level after total knee arthroplasty. 2. Level of knee swelling after total knee arthroplasty. 3. Range of motion of the knee after total knee arthroplasty. 4. Functional abilities of patients after total knee arthroplasty. 5. Length of time for returning to full functional activity Just after 6 weeks of intervention
Secondary Outcome This study was applied to fill this gap of knowledge and find an optimum rehabilitation strategy reaching by patients with TKA to maximum level of independence in their activities of daily living. At the end of intervention just after 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Knee unit at Mansoura University and Physical therapy department at Mansoura Health insurance Hospital Al-gomhoreia Street and Al-geish Street Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Mahmoud Nasr Gudaiedat Al-hala Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Mahmoud Nasr Tolba Gudaiedat Al- Hala, Mansoura, Dakahlia Mansoura Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mahmoud Nasr Tolba ahmednasr6080@yahoo.com 0201001897666 Gudaiedat El Hala - Mansoura, Dakahlia.
City Postal code Country Position/Affiliation
Mansoura Egypt Assistant lecturer at Basic Science Department at Faculty of Physical Therapy Delta University for Science and Technology
Role Name Email Phone Street address
Scientific Enquiries Rania Nagy Karkousha rania.nagy@pt.cu.edu.eg 0201227244630 El Tahrir St. in front of Ben Al Sarayat Traffic, Dokki, Giza
City Postal code Country Position/Affiliation
Giza Egypt Assistant professor of Basic Science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Adham Abdel Raouf Elsharkawy Elgeidi elgeidi@doctors.org.uk 0201061057973 Gihan st. in front of Al- Defaa Al- Madany, Mansoura, Dakahlia.
City Postal code Country Position/Affiliation
Mansoura Egypt Assistant professor of Orthopedics and Traumatology at Orthopedic Department at Faculty of Medicine Mansoura University.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Pre intervention data from participants in form of level of functional abilities, level of knee swelling, knee range of motion and level of pain intensity Informed Consent Form,Statistical Analysis Plan,Study Protocol From 8/2020 till 7/2021 Open and controlled access journals
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