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.: PACTR202111695655746 Date of Approval: 19/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasonographic guided intra articular steroid and hyaluronic acid and injection in adhesive capsulitis with and without suprascapular nerve block
Official scientific title Ultrasonographic guided intra articular steroid and hyaluronic acid injection in adhesive capsulitis with and without suprascapular nerve block
Brief summary describing the background and objectives of the trial The aim of the present study was to compare the effectiveness of Ultrasonographic guided intra articular steroid and hyaluronic acid and injection in adhesive capsulitis with and without suprascapular nerve block in providing pain relief, functional improvement, and reduction of disabilities.
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 compare the effectiveness of Ultrasonographic guided intra articular steroid and hyaluronic acid and injection in adhesive capsulitis with and without suprascapular nerve block in providing pain relief, functional improvement, and reduction of disabilities
Anticipated trial start date 10/12/2020
Actual trial start date
Anticipated date of last follow up 01/11/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
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 created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Ultrasonographic guided intra articular steroid injection in adhesive capsulits once once ultrasound guidance intra-articular steroid injection into the shoulder joint was performed by posterior approach (4 ml of 2% lidocaine and 2 ml of 40 mg/ml triamcinolone half of them had ultrasound-guided (USG) SSN block provided sufficient anaesthesia, (9 ml of 0.5% bupivacaine for nerve block and 1 ml of 0.4% dexamethasone sodium phosphate to increase the duration of nerve blockade). 40 Active-Treatment of Control Group
Experimental Group intra articular injection of hyaluronic acid ultrasound guided. once once ultrasound guidance intra-articular hyaluronic acid injection into the shoulder joint was performed by posterior approach (4 ml of 2% lidocaine and hyaluronic acid 2 ml ). half of them had ultrasound-guided (USG) SSN block provided sufficient anaesthesia, (9 ml of 0.5% bupivacaine for nerve block and 1 ml of 0.4% dexamethasone sodium phosphate to increase the duration of nerve blockade). 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients of both sex aged between 35 and 75 years complaning of shoulder pain and stiffness persisting ≥12 weeks were recruited. 2. Patient who had received conservative management of pain with no relief from symptoms for at least 2 weeks were screened for eligibility. 1. Shoulder pain due to secondary causes, e.g., acute trauma, fractures, bony deformity, glenohumeral joint pathology, acromioclavicular joint pathology, and rotator cuff disorder . 2. Patients with known contraindications for block interventions, e.g., bleeding disorder, acute and chronic infection. 3. Individual having comorbid conditions such as uncontrolled diabetes, chronic renal failure, thyroid diseases, coronary artery disease, stroke, and connective tissue disorders were excluded from the study. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 75 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 08/12/2020 Al Azhar university faculty of medicine Ethical committee
Ethics Committee Address
Street address City Postal code Country
71524 king faisal St Assiut 71511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pre and post intervention assessment using both active and passive ranges and visual analogue scale (VAS) and range of movement (ROM) measurements by goniometer. baseline and 1 weak, 3 weak and 6 weak after injection
Secondary Outcome decrease pain and improve range of motion baseline 1 weak ,3 weak ,6weak
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Azhar university Assiut branch faculty of medicine 71524 king faisal St Assiut 71511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Al Azhar university Assiut branch faculty of medicine faisal St Assiut 71511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al Azhar university Assiut branch faculty of medicine 71524 king faisal St Assiut 71511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mosalem ahmosallam@yahoo.com 01006424150 faisal St
City Postal code Country Position/Affiliation
assiut 71511 Egypt Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Mohammed Elwan drelwan77@yahoo.com 01093105199 faisal St
City Postal code Country Position/Affiliation
Assiut 71511 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Abdelhafeez Moshreif Dr.moshrif@live.com 01062930120 faisal St
City Postal code Country Position/Affiliation
Assiut 71511 Egypt Assistant Professor
Role Name Email Phone Street address
Principal Investigator Eman Mohammed emandr95@yahoo.com 01013770341 faisal St
City Postal code Country Position/Affiliation
Assiut 71511 Egypt Resident Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Immediately following publication. end after one year Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal Data are available indefinitely at (Link to be included).
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 - 17/11/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information