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.: PACTR201811597207089 Date of Approval: 14/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intra articular corticosteroid injection versus shock wave and traditional physiotherapy modalities in treatment diabetic frozen shoulder.
Official scientific title Intra articular corticosteroid injection versus extracorporeal shock wave and traditional physiotherapy modalities in treatment diabetic frozen shoulder.
Brief summary describing the background and objectives of the trial study effects of intra articular injection of corticosteroid drugs versus traditional physiotherapy modalities and shock wave in treatment of both pain and range of motion.
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 04/11/2018
Actual trial start date 07/11/2018
Anticipated date of last follow up 06/02/2019
Actual Last follow-up date 15/02/2019
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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 Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group extracorporeal shock wave and other traditional physiotherapy modalities shock wave ( 4 bar, 8 frequency, 2000 shocks) 20 min of hot packs.30 min of transcutanous nerve stimulation, shoulder mobilization techniques and active (assisted - free - resisted) range of motion. three months ( three session per week) shock wave ( 4 bar, 8 frequency, 2000 shocks) 20 min of hot packs.30 min of transcutanous nerve stimulation, shoulder mobilization techniques and active (assisted - free - resisted) range of motion. 25
Control Group intra articular injection of corticosteriod 1 cm of dexamethasone + 10 cm of lignocaine three months ( one injection every month) injection of 1 cm of dexamethasone + 10 cm of lignocaine in shoulder joint every month for three months 25 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Efficacy on pain and/or function of both type of intervention. efficacy on shoulder range of motion. adhesive capsulitis patient. diabitic frozen shoulder. shoulder pain from causes other than diabetic adhesive capsulitis and frozen shoulder. the use of corticosteroid injection in conjunction with distension arthrography. manipulation under anaesthesia. Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 64 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 02/11/2018 cairo university ethical committe
Ethics Committee Address
Street address City Postal code Country
elziat street cairo 43561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain and functional ability, shoulder range of motion every month
Secondary Outcome blood glucose level in both fasting and post prandial every month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outclinc of kaferelshiek university hosbital Elgaish street kaferelshiek Egypt
out clinic of professor Dr. hany hamed professor of orthopedic surgery Elmoharbien Elgdedida kaferelshiek Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded el gaiesh kaferelshiek Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor kaferelshiek university elgaiesh kaferelshiek Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed ebrahim elarian madii cairo Egypt
hany hamed slah salem kaferelshiek Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mahmoud ewidea mahewidea@gmail.com 00201005098423 elgaiesh street
City Postal code Country Position/Affiliation
kaferelshiek Egypt assistant professor faculty of physical therapy
Role Name Email Phone Street address
Public Enquiries hany hamed hanyhamed123@gmail.com 00201220157706 elgeish
City Postal code Country Position/Affiliation
kafer Egypt assistant professor of orthopedic surgery
Role Name Email Phone Street address
Scientific Enquiries ahmed elarian dr_ahmed_elerian77@yahoo.com 0201288280082 el mady
City Postal code Country Position/Affiliation
cairo Egypt professoe of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes if its requirement of WHO I do not mind to share my results when completed Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 3 months after finishing my trial I do not understand what it mean
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