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.: PACTR202007638955907 Date of Registration: 28/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Shock Wave Therapy versus High Power Laser Therapy in Knee Osteoarthritis
Official scientific title Shock Wave Therapy versus High Power Laser Therapy in Knee Osteoarthritis
Brief summary describing the background and objectives of the trial The purpose of this study was to compare the effects of extracorporeal shock wave therapy (ESWT) and High-Intensity Laser Therapy (HILT) in patients with knee OA. Setting: A physical therapy outpatient clinic.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 05/08/2020
Actual trial start date 02/09/2020
Anticipated date of last follow up 10/10/2020
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 Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group extracorporeal shock wave therapy one session a week for four weeks 4 weeks the patient was placed in a supine lying position with knees bent to 90o. The therapist applied 1,000 pulses of a shockwave with an energy dose of 0.05 mJ/mm2. He directed it to the tender point of the medial tibial plateau area in the affected knee. The therapist asked the participants to refrain from physical activities such as jogging, lifting heavy objects for 48 hours following each session. 20 Active-Treatment of Control Group
Experimental Group High Intensity Laser Therapy They received three sessions a week for four weeks. 4 weeks the handpiece of pulsed Nd:YAG laser was positioned in contact and perpendicularly while the patient in a supine lying position with the knee flexed at 30° to open the joint surfaces to the laser beam (optical windows). A separation distance of around 1 cm between the handpiece and the skin was also maintained throughout the treatment. The scanning was performed transversely and longitudinally in the anterior, medial, and lateral aspects of the knee joint with emphasis on the application on the joint line between the tibial and femoral epicondyles. The intensity of the HILT was level 2, the frequency was 11 Hz with total energy delivered to the patient during one session was 1,500 mJ/cm2 through three phases of treatment. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients diagnosed with knee OA based on the clinical criteria of the American College of Rheumatology and those who had tenderness in the medial tibial plateau. history of neurologic diseases and those with external injuries, surgeries, cancer, and malignant tumors affecting the knees. Also, patients who have received intraarticular injection on the affected knee within the past 3 months Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 55 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 24/06/2020 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elziat st. bein srayyat giza ,Egypt Giza 11411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome visual analogue scale (VAS). Pain intensity before and after intervention
Secondary Outcome Distance walked in 6 minutes before and after intervention
Secondary Outcome Western Ontario and McMaster Universities Osteoarthritis for functional disability. before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic of Cleopatra Hospital 39 Cleopatra street salah eldin square heliopolis Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding 77 shalhoub street ahmed essmat ain shams, Cairo .egypt Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Cleopatra Hospital 39 Cleopatra street Heliopolis Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Serag Eldein Mahgoub Mostafa drsergany_79@hotmail.com 00201140974442 77 shalhoub street ahmed essmat ain shams, Cairo .Egypt
City Postal code Country Position/Affiliation
Cairo Egypt Associate professor Basic Sciences department Faculty of Physical Therapy Cairo University.
Role Name Email Phone Street address
Public Enquiries Nesma Helmy nesmaahmed101@gmail.com 00201287902936 7Ahmed elzyat street bein srayat .Giza .Egypt
City Postal code Country Position/Affiliation
Giza Egypt Lecturer basic science department Faculty of physical therapy Beni suef university Faculty of physical therapy Delta University for Science and Technology
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mostafa drsergany_79@hotmail.com 00201140974442 77 shalhoub street ahmed essmat ain shams, Cairo .Egypt
City Postal code Country Position/Affiliation
Cairo Egypt Associate professor Basic Sciences department Faculty of Physical Therapy Cairo University.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data summary of results Study Protocol 5 month period of time after publication Controlling access to data
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