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.: PACTR201910580959319 Date of Approval: 09/10/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Extracorporeal shock wave therapy in diabetic patients with frozen shoulder
Official scientific title Effectiveness of radial extracorporeal shock-wave therapy versus ultrasound-guided low dose intra-articular steroid injection in improving shoulder pain, function and range of motion in diabetic patients with shoulder adhesive capsulitis
Brief summary describing the background and objectives of the trial Shoulder adhesive capsulitis is common in diabetic patients. It has a considerable impact on patients quality of life and resistant to treatment. Extracorporeal shock wave therapy was found to be effective in treatment of the primary frozen shoulder. the aim of this study is to compare the effectiveness of radial extracorporeal shock wave therapy versus low dose ultrasound-guided intraarticular steroid injection in relieving pain and improving function and shoulder range of motion in diabetic patients with shoulder adhesive capsulitis.
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 25/12/2017
Actual trial start date 25/12/2017
Anticipated date of last follow up 24/12/2018
Actual Last follow-up date 24/12/2018
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants) 103
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group radial Extracorporeal shock wave therapy rESWT one session of rESWT per week four weeks rESWT was administered with BTL-5000 BTL Industries, Inc., USA 52
Control Group Ultrasound guided intraarticular steroid injection Once One Injection 20mg of triamcinolone acetonide was injected under ultrasound guidance 51 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with controlled type 2 DM Unilateral adhesive capsulitis of the shoulder symptoms duration of more than 3 months limited shoulder range of motion more than 25% in at least two directions normal X-ray shoulder except for osteoporosis Uncontrolled DM Rotator cuff tear or calcifications bilateral shoulder affection Previous surgery or trauma bleeding disorders pregnancy implanted pacemaker unwilling to participate 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 19/12/2017 Research Ethics Committee Faculty of Medicine Suez Canal University
Ethics Committee Address
Street address City Postal code Country
Ring Road Ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome quick Disabilities of the Arm, Shoulder, and Hand And Shoulder pain by VAS baseline, and at 4,8,and 12 weeks from baseline
Secondary Outcome Shoulder Range of Motion Baseline, and at 4, 8, and 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University Hospitals Ring Road Ismaila 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tasneem ElDessouky ElNaggar Ring Road Ismailia 41522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Suez Canal University Ring Road Ismailia 41522 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Halal Ring ROAD Ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tasneem El Naggar tasneemeldesouky@yahoo.com 00201024871357 Ring Road Faculty of Medicine, Department of Physical Medicine, Rheumatology and Rehabilitation
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt Assistant Lecturer of PMR
Role Name Email Phone Street address
Scientific Enquiries Aly Mohamed ali_elsayed@med.suez.edu.eg 00201066406438 ring road, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
City Postal code Country Position/Affiliation
Ismaila 41522 Egypt Associate Prof. PMR
Role Name Email Phone Street address
Public Enquiries Ahmed Maaty aimaaty@hotmail.com 00201004978451 Ring Road Faculty of Medicine, Suez Canal University
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt Lecturer of PMR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the sharing will be through this email: aimaaty@hotmail.com Informed Consent Form,Study Protocol Within 2 years of the completion date. Access will be restricted to academic requests after reviewing the qualification and type of data requested
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