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.: PACTR201811706960533 Date of Approval: 12/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Different Dose-Related Effects of Radial Extracorporeal Shock Wave on knee Osteoarthritis
Official scientific title Different Dose-Related Effects of Radial Extracorporeal Shock Wave on knee Osteoarthritis
Brief summary describing the background and objectives of the trial Osteoarthritis is the most common cause of pain and disability worldwide, especially in the elderly population. Women are affected more frequently than men, and the hip and knee joints are most commonly affected. Despite its high prevalence and negative impact on quality of life of affected individuals, there is no cure for OA. Therapeutic measures aim to relieve painful symptoms and maximize functional capacity and quality of life, while minimizing adverse effects from drugs and invasive interventions. Patients worldwide with knee OA reporting severe disabling and refractory pain are usually referred for a total or partial arthroplasty.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EFD MANOVA KL
Disease(s) or condition(s) being studied Knee osteoarthritis,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/05/2018
Actual trial start date
Anticipated date of last follow up 15/02/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants) 54
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 the patients will be assigmed randomly by random generator and will be allocated to three groups the allocation will be determined by a third person (the holder of the sequence whois situated off site) Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised the patients will be assigmed randomly by random generator and will be allocated to three groups the allocation will be determined by a third person (the holder of the sequence whois situated off site) Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised the patients will be assigmed randomly by random generator and will be allocated to three groups the allocation will be determined by a third person (the holder of the sequence whois situated off site) Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised the patients will be assigmed randomly by random generator and will be allocated to three groups the allocation will be determined by a third person (the holder of the sequence whois situated off site) Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised the patients will be assigmed randomly by random generator and will be allocated to three groups the allocation will be determined by a third person (the holder of the sequence whois situated off site) Open-label(Masking Not 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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group low energy radial extracorporeal shock wave therapy four sessions once per week one month low energy radial shock wave therapy (2000 shock/ session, 10 Hz and 1 bar plus strenghening exercise 18 Dose Comparison
Experimental Group medium energy radial extracorporeal shock wave therapy four sessions once per week one month medium energy radial shock wave therapy (2000 shock/session, 10Hz and 4 bars) plus strengthening exercises 18 Dose Comparison
Control Group sham radial extracorporeal shock wave therapy four sessions once per week one month sham shock wave therapy patients will receive shockwave therapy (2000 shock/session, 10Hz and EFD 0 mJ/mm²) plus strengthening exercises 18
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) Subjects age between 45- 55 years old. (2) Symptomatic knee OA for at least 3 months according to clinical criteria of American College of Rheumatology. (3) Radiologic findings had to be compatible with knee OA, with kelgren and Lawrence (K-L) grade 2 or 3 in a simple X ray. (4) Tenderness on medial tibial plateau. (5) Intensity of pain: visual analogue scale equal to 5 or greater (6) Failure of two or more types of previous conservative treatment (medication, anti-inflammatory drugs, physical therapy, stretching, acupuncture, orthotics and others) (7) Availability to attend the hospital during the treatment and follow up (1) Neuorological and vestibular system disorder, systematic inflammatory disease, steroid injections in the last six months. (2) Any contraindication to magnetic resonance imaging or radiography, or trauma history on knee Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 45 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
No 30/08/2018 faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El zayed street, Dokki, Giza, Egypt Giza 12652 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome proprioception will be measured by 1- Biodex multi-joint system pro Isokinetic dynamometer before and at the end of the treatment sessions
Secondary Outcome physical function will be measured by Arabic-language version of the knee injury and osteoarthritis outcome score physical function short form before and at the end of the treatment sessions
Primary Outcome pain will be measured by visual analogue scale before and at the end of the treatment sessions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
modern university for thechnology and information modern university street- El hadaba EL wosta cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of physical therapy cairo university 7Ahmed elzayat street, dokki Giza 12613 Egypt
Cairo university 1 gamma street Giza 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy 7 Ahmed Elzayad street, Dokki Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof Dr Ragia Mohammed Kamel 7 el tahreer street- el dokki Giza Egypt
Dr Salah El Din Bassit 9 abbas el akad street cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries ragia Kamel radwafayek@gmail.com 01222404923 7 el tahreer street el dokki
City Postal code Country Position/Affiliation
Giza 8655 Egypt professor of physical therapy basic science department cairo university
Role Name Email Phone Street address
Scientific Enquiries salah el din bassit utcsalah@gmail.com 01020233023 9 abbas el akkad street
City Postal code Country Position/Affiliation
cairo 11765 Egypt assisstant professor of physical therapy basic science department cairo university
Role Name Email Phone Street address
Principal Investigator radwa fayek radwafayek@gmail.com 01004466229 417t,hadayeq elahram, Giza. Egypt
City Postal code Country Position/Affiliation
Giza 12611 Egypt lecturer Assistant at basic science department at modern university for technology and information
Role Name Email Phone Street address
Scientific Enquiries Shaimaa Taha dr_shymaelshazly@yahoo.com 01229823327 7 el tahreer street el dokki
City Postal code Country Position/Affiliation
Giza 12511 Egypt Lecturer at basic science department faculty of physical therapy. cairo university
REPORTING
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Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information