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.: PACTR201711002410392 Date of Approval: 07/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Dexamethasone Phonophoresis in the Treatment of Knee Osteoarthritis
Official scientific title Effect of Dexamethasone Phonophoresis in the Treatment of Knee Osteoarthritis
Brief summary describing the background and objectives of the trial Osteoarthritis of the knee is the most common form of arthritis and leads to more activity limitations (e.g., disability in walking and stair climbing) than any other disease, especially in the elderly. Symptomatic knee OA (defined as pain on most days plus positive findings on a radiograph of the symptomatic knee) occurs in 6.1% of adults over the age of 30. Many studies reported the effect of phonophoresis of topical NSAIDs in reducing the symptoms of articular degenerative diseases and comparison between the efficiency of these treatments on reduction of inflammation. With regard to high prevalence of knee osteoarthritis and its debilitating pain in patients, it is essential to explore new methods of osteoarthritis treatment. Therefore, in order to improve therapeutic methods, reduce health care costs, and reduce OA symptoms, the effect of phonophoresis of dexamethasone on the treatment of knee OA will be assessed and compared with ultrasound therapy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Osteoarthritis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2017
Actual trial start date 01/08/2017
Anticipated date of last follow up 26/10/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 44
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
nil known Mohamed Ahmed Said Ahmed
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 coin tossing sealed envelopes 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 Dexamethasone phonophoresis 12 Sessions 1 month A continuous mode ultrasound at a frequency of 1 MHz and intensity of 1 W/cm² with treatment duration of 10 minutes using coupling media of 0.4% dexamethasone gel on the maximum pain point in the medial compartment of the knee 22
Control Group ultrasound therapy 12 Sessions 1 month A continuous mode ultrasound at a frequency of 1 MHz and intensity of 1 W/cm² with treatment duration of 10 minutes using coupling media of ultrasound gel on the maximum pain point in the medial compartment of the knee 22 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with mild to moderate medial tibiofemoral osteoarthritis on the basis of the Radiological criteria (Kellgren-Lawrence grade II-III) and American College of Rheumatology criteria (ACR) Rheumatologic problems such as rheumatoid arthritis. Previous surgery on the knee joint. Previous fracture of the lower extremity with knee joint involvement. Severe knee osteoarthritis. Thrombosis of the lower limbs. People who are not able to cooperate in order to complete the questionnaire for any reason. Previous physiotherapy treatment for knee in last 6 months. History of injections in knee joint in the last 6 months. Balance disorders. Neuropathy and sensory disorders. Skin damage around the knee. Contraindications or precautions for the use of corticosteroids (e.g. High blood pressure, osteoporosis and diabetes). Contraindications or precautions for the use of ultrasound. 40 Year(s) 65 Year(s) Female
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 07/06/2017 Faculty of physical therapy- Cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Giza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain using VAS (Visual Analog Scale) Before starting first session. After last session.
Primary Outcome Functional mobility using WOMAC Arabic version (The Western Ontario and McMaster Universities Osteoarthritis Index) and Timed Up and Go Test (TUG). Before starting first session. After last session.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El-Sahel Teaching Hospital Denshwai street, shobra Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Ahmed Said Giza Egypt
Mohamed Ahmed Said building 9, Mohamed hanafy Salman street, Elwarak Giza 12674 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed Ahmed Said building 9, Mohamed hanafy Salman street, Elwarak Giza 12674 Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Salwa Fadl Abdelmajeed Building 22, Haroon street, Dokki Giza 12611 Egypt
Nasr Awad Abd Elkader Building 6, South Sinai Street, Maadi Giza 11728 Egypt
Emad Samuel Boles Saweeres Building 15, shobra street Cairo 11672 Egypt
Ahmed Roshdy Fares Building 67, Elgesh street, Elmanial Cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Ahmed msa3ed@live.com 00201113391681 9, mohamed hanafy salman street
City Postal code Country Position/Affiliation
Giza Egypt Physical Therapist
Role Name Email Phone Street address
Public Enquiries Nasr othman dr.nasrawad@gmail.com 00201025771117
City Postal code Country Position/Affiliation
Giza Egypt manager of postgradute studies affairs
Role Name Email Phone Street address
Scientific Enquiries Nast Othman dr.nasrawad@gmail.com 0020102 577 1117 Building 6, South Sinai Str, Maadi
City Postal code Country Position/Affiliation
Cairo 11728 Egypt Lecturer: Physical Therapy, Surgery - Musculoskeletal Disord, Faculty Physical Therapy, Cairo Univ
REPORTING
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