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.: PACTR202002823070938 Date of Approval: 04/02/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Shock wave therapy versus intra-articular platelt in knee osteoarthritis
Official scientific title Efficacy of shock wave therapy versus intra-articular platelt-rich plasma injection in management of knee osteoarthritis
Brief summary describing the background and objectives of the trial This study aim for comparison between the effect of PRP and shock wave in cases of 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 Rehabilitation
Anticipated trial start date 01/10/2019
Actual trial start date
Anticipated date of last follow up 30/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
P.T.REC/012/002310
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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional physical therapy program 3 sessions per week 12 sessions Stretch exercises for hamstring and cafe muscle Strength exercise for quadriceps muscle Ultrasound Hot packs 15 Active-Treatment of Control Group
Experimental Group Shock wave One session per week 4 sessions Shock wave Stretch exercise for hamstring and cafe muscle Strength exercise for quadriceps muscle Ultrasound Hot pack 15
Experimental Group Injection of intra articular platelet rich plasma Only one session One session PRP Strech exercise for hamstring and cafe muscle Strength exercise for quadriceps Ultrasound Hot pack 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients have grade 2 or 3 of unilateral KOA Age 40 to 65 All patients have functional disturbance assessed by (WOMAC) BMI <30 Traumatic injury to the knee joint Any neurological condition Several knee deformities Diabetes Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 65 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 31/03/2019 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayat Bein Elsarayat Dokki Giza Giza 12618 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Laser goniometer Before and after treatment
Secondary Outcome Visual analogue scale Before and after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Soad kfafi hospital 6 October Motamyz neighborhood Giza Giza 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sara Elsamahy 6 Abdelaziz Fahmy st. 6 October Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy Cairo university 7 Ahmed Elzayat st. Bein Elsarayat, Dokky, Giza Giza 12618 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Hussein Elgendy 7 Ahmed Elzayat st Bein Elsarayat, Dokki, Giza Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Hussein Elgendy prof.mgendy@hotmail.com 01005747169 7 Ahmed Elzayat st Bein Elsarayat Dokki Giza
City Postal code Country Position/Affiliation
Giza Egypt Professor of physical therapy
Role Name Email Phone Street address
Principal Investigator Mohamed Serag drseragany-79@hotmail.com 011460974442 7 Ahmed El Zayat st Bein Elsaryat Dokki Giza
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of physical therapy
Role Name Email Phone Street address
Public Enquiries Mohamed Serag drseragany-79@hotmail.com 01140974442 7 Ahmed Elzayat st Bein Elsaryat Dokki Giza
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Mohamed Serag drseragany-79@hotmail.com 01140974442 7 Ahmed Elzayat st Bein Elsaryat Dokki Giza
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 Individual participant data that underline the results reported in this article after deidentification ( text, tables, figures and appendices) Statistical Analysis Plan,Study Protocol 6 months following publication Any one who wishes to access the 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