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.: PACTR201805003383422 Date of Approval: 13/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Magnetic Stimulation on Cross-Sectional Area of Quadriceps Muscle in Knee Osteoarthrititic Patients
Official scientific title Effect of Magnetic Stimulation on Cross-Sectional Area of Quadriceps Muscle in Knee Osteoarthrititic Patients
Brief summary describing the background and objectives of the trial Magnetic stimulation (MS) is a novel noninvasive method to preserve muscle contour . The stimulating effect of weak stimulating magnetic field (WSMF) on proliferation and differentiation of skeletal muscle cells, and increase in [Ca¿]ions were observed for the first time for magnetic field with the magnetic flux density equal to 160¿200 micro Tesla. the Quadriceps muscles play critical role in protecting the articular cartilage of the knee from excessive impact loading .In this study , a new method of developing muscular function will be used by Magnetic stimulation , the technical parameters of magnetic stimulator provide painless stimulation of skeletal muscles and activation of high ¿threshold motor units, which normally are not recruited ,The method proposed can be used to preserve muscle cross section , as well as in the prevention of muscles atrophy after an injury of the spinal cord and skeletal muscles.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) no acronym
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,knee osteoarthritis,Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/08/2018
Actual trial start date 01/08/2018
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date 31/12/2018
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Not yet recruiting
Publication URL still not published
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomization from outpatient clinic Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group magnetic stimulation + isomtric strength 30 minutes twice weekly for 3 weeks magnetic stimulation 15 Active-Treatment of Control Group
Control Group isometric strength exercise 3 sets each set contain 10 repetitions twice weekly for 3 weeks isometric strength exercise 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Thirty patient of mild to moderate knee arthritis (primary or secondary) -Age will range from 40 to 60 years old, male and female. - ultrasound¿s calliper will be used to measure quadriceps cross section before and after magnetic intervention. - Individuals with malaligned or lax knee. - Individuals with history of cancer. - Patients with advanced osteoarthritis. 40 Year(s) 60 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 06/05/2018 at faculty of physical therapy , cairo university
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st -Dokki Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome increase cross section of quadriceps muscle after 6 sessions of intervention
Secondary Outcome decrease pain after 6 sessions ,visual analogue scale will be used to indicate pain level
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy outpatient clinic EL-tahrir st- in front of Ben-El-Sarayat,Traffic -Dokki Giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
null null null null Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor prof .Dr. Haytham M El Hafez 7 Ahmed Elzayyat St Dokki, Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
dr.Ahmed fathy Genidy 6 october St -sheikh zaied cairo 12573 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haytham El hafez elhafez@yahoo.com 01001909630 6 october -sheikh zaied
City Postal code Country Position/Affiliation
cairo 12612 Egypt professor
Role Name Email Phone Street address
Principal Investigator soheir shehata soheirshehata@yahoo.com 01224003374 25 shubra street
City Postal code Country Position/Affiliation
cairo 11672 Egypt Ass.professor
Role Name Email Phone Street address
Public Enquiries Haytham El hafez elhafez@yahoo.com 01001909630 6 october -sheikh zaied
City Postal code Country Position/Affiliation
cairo 12612 Egypt professor
Role Name Email Phone Street address
Scientific Enquiries Magda Ramadan Magdaramadan2000@yahoo.com 01025891348 7 Ahmed Elzayat St,Dokki, Egypt
City Postal code Country Position/Affiliation
Giza 12612 Egypt lecturer
REPORTING
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