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.: PACTR202111473947054 Date of Approval: 26/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound-guided injection of low molecular weight hyaluronic acid versus steroid for inflammatory and degenerative sacroiliitis: a controlled clinical trial
Official scientific title Ultrasound-guided injection of hyaluronic acid versus steroid for sacroiliitis
Brief summary describing the background and objectives of the trial Background: Sacroiliitis may be degenerative (DSI) or inflammatory (ISI) and the latter is one of the clinical features of spondyloarthropathies. Aim: To determine the effect of hyaluronic acid versus corticosteroid injection for chronic sacroiliac joint arthropathy.
Type of trial CCT
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 Treatment: Drugs
Anticipated trial start date 01/01/2021
Actual trial start date 01/02/2021
Anticipated date of last follow up 26/09/2021
Actual Last follow-up date 22/10/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 40
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 Non-randomised Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group injection of sacroiliac joint with low molecular weight hyaluronic acid once once The sacroiliac joint injection was done under aseptic precautions using ultrasound guidance (TOSHIBA xario 200, Tokyo, Japan). While the patient was in a prone position, the transducer was settled in a transverse direction at the level of the sacral hiatus, and the sacral cornuae were identified. Then, the lateral edge of the sacrum was identified by moving the transducer laterally, and a second bony contour, the ileum, was identified by following this bony edge in a cephalic direction. The SIJ was observed as a hypoechoic cleft area between the 2 echogenic lines of the sacrum and iliac bone as previously described. The posterior caudate SIJ, the portion of the joint into which the injection was performed, was identified by tilting the transducer in a caudal direction. After administration of local anesthesia with lidocaine using a 22 gauge cutting–edge spinal needle. with the needle inside the joint, the patient was asked about the disappearance of pain to exclude the spinal radicular pain then a mixture of lidocaine with low molecular weight hyaluronic acid was injected. 20
Control Group Steroid injection group once once The sacroiliac joint injection was done under aseptic precautions using ultrasound guidance (TOSHIBA xario 200, Tokyo, Japan). While the patient was in a prone position, the transducer was settled in a transverse direction at the level of the sacral hiatus, and the sacral cornuae were identified. Then, the lateral edge of the sacrum was identified by moving the transducer laterally, and a second bony contour, the ileum, was identified by following this bony edge in a cephalic direction. The SIJ was observed as a hypoechoic cleft area between the 2 echogenic lines of the sacrum and iliac bone as previously described. The posterior caudate SIJ, the portion of the joint into which the injection was performed, was identified by tilting the transducer in a caudal direction. After administration of local anesthesia with lidocaine using a 22 gauge cutting–edge spinal needle. with the needle inside the joint, the patient was asked about the disappearance of pain to exclude the spinal radicular pain then a mixture of lidocaine with betamethazone dipropionate was injected. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patient above 18 years old patient with radiculopathy infection previous surgical intervention pregnant or postpartum women Adult: 19 Year-44 Year,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 31/01/2021 Faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Al-Azhar University square Assuit 71511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VAS for pain zero day -one week-two week- one month
Secondary Outcome intervention related side effects 0, week1, week2, and week 4
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
azhar assuit university hospital and outpatient al waleedya assuit 71511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
AlAzhar university hospial Assuit Al-Azhar University Square Assuit 71511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AlAzhar University hospital Assiut Al-Azhar university square Assuit 71511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohammed ismaeal Abdelkreem and Abdelhfeez Moshrif AlAzhar University square Assuit 71511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries dr.Abdelhfeez Moshrif Dr.moshrif@live.com +201062930120 Al-Azhar University square
City Postal code Country Position/Affiliation
Assiut 71524 Egypt assist Professor of rheumatology
Role Name Email Phone Street address
Principal Investigator Khalid Hussein kh1121992@gmail.com +201144015278 Al-Azhar University square
City Postal code Country Position/Affiliation
Assiut 71524 Egypt resident physician
Role Name Email Phone Street address
Public Enquiries Mohamed Elwan drelwan77@yahoo.com +201093105199 Al-Azhar University square
City Postal code Country Position/Affiliation
Assiut 71524 Egypt lecturer
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 de identification (text, tables,figures and appendices) Study Protocol Immediately following publication end after one year Researchers who provides 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
https 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