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.: PACTR201711002482359 Date of Approval: 28/07/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of static stretching exercises versus proprioceptive neuromuscular facilitation stretching techniques on pain severity and functional perform
Official scientific title Efficacy of static stretching exercises versus proprioceptive neuromuscular facilitation stretching techniques on pain severity and functional performance in patients with knee osteoarthritis
Brief summary describing the background and objectives of the trial This study is aiming to determine the efficacy of Static stretching exerises Versus Proprioceptive neuromuscular facilitation (PNF) stretching techniques On Pain Severity And Functional Performance In patients with Knee Osteoarthritis
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied knee osteoarthritis,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 15/06/2016
Actual trial start date 15/06/2016
Anticipated date of last follow up 15/06/2018
Actual Last follow-up date 15/06/2018
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
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 Stratified allocation where factors such as age, gender, centre, or previous treatment are used in the stratification (please specify factors used for stratification) Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group treatment static stretching exercises 10 repetitions 45 minutes Active-assistive stretching of knee was performed in the supine position, and holding the positions of knee flexion and extension at the end points of the ROM for 30 seconds for each and 20s periods of rest 15
Experimental Group proprioceptive neuromuscular facilitation stretching techniques 10 repetitions 45 hold - relax stretching exercises which is type of PNF stretching techniques 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women and men aged 50 ¿70 years _ Clinical knee osteoarthritis according to the American College of Rheumatology Clinical Criteria _ Kellgren and Lawrence (KL) radiographic osteoarthritis grade 2 and 3 (mild to moderate radiographic osteoarthritis) _ Severe knee osteoarthritis according to the KL classification (grade 4) _ Other known major musculoskeletal impairments in the lower extremities or the back or prostheses in any joint of the lower extremities _ Known serious coronary heart diseases or cancer _ Body mass index >35 _ Scheduled for surgery in any joint _ Known mental or psychological diseases _ Known drug abuse _ Persons who already perform sports relate moderate physical activity more than two times a week. Patients with lowback pain arising from a serious medical condition, such as fracture, infection, cancer or cauda equina syndrome. 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 15/06/2016 research ethical committee- faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 - Ahmed Elziat st. Ben Elsaryat - El dokki - Giza - Egypt giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Flexibility Test Of hamstring and rectus femoris muscles. ¿ Flexibility Test Of hamstring and rectus femoris muscles. ¿
Primary Outcome The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (Bellamy Et Al., 1988). ¿ The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (Bellamy Et Al., 1988). ¿
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national authority of health insurance 43 ahmed maher st. quesna menofia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
cairo university 7 ahmed elziat st. ben elsayat - el dokki - giza 12612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university cairo University
Primary Sponsor cairo university 7 ahmed elziat st. ben elsayat - el dokki - giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
prof
prof salwa fadl 7 - ahmed elziat st. ben elsayat - el dokki - giza - egypt giza 12612 Egypt
prof hamid khozamy 7 - ahmed elziat st. ben elsayat - el dokki - giza - egypt giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ehab ali ehab aliehab93@gmail.com 00201223674916 7 ahmed elzayat st. ben elsarayat - eldokki
City Postal code Country Position/Affiliation
giza 12612 Egypt physiotherapist
Role Name Email Phone Street address
Public Enquiries ehab ali ehab aliehab93@gmail.com 00201223674916 7 ahmed elzayat st. ben elsarayat - eldokki
City Postal code Country Position/Affiliation
giza 12612 Egypt physiotherapist
Role Name Email Phone Street address
Scientific Enquiries ehab ali aliehab93@gmail.com 00201223674916 7 ahmed elziat st. ben elsaryat - eldokki
City Postal code Country Position/Affiliation
giza 12612 Egypt physiotherapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information