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.: PACTR202006697506244 Date of Approval: 09/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound Guided Injection of Steroids versus Platelet Rich Plasma for Sacroiliac Joint Chronic Pain Management
Official scientific title Ultrasound Guided Injection of Steroids versus Platelet Rich Plasma for Sacroiliac Joint Chronic Pain Management
Brief summary describing the background and objectives of the trial The sacroiliac joint (SIJ) is the largest axial joint in the body consisting of the articulation of the lateral sacrum with the posteromedial ilium having a synovial part and a fibrous part. It transfers weight from the spine to the lower limbs and provides certain elasticity to the pelvic ring together with the symphysis pubis. SIJ pain is an underappreciated source of mechanical low back pain, affecting between 15 and 30% of individuals with chronic i.e more than 3 months, non-radicular low back pain below the L5 vertebra. The joint capsule, surrounding ligaments, and the intra-articular portion of the joint have been reported to be potential pain generators. The treatment of SIJ pain remains a therapeutic challenge. Besides physiotherapy and systemic therapies such as nonsteroidal anti-inflammatory drugs (NSAIDs), intra-articular and periarticular injections of SIJ, radiofrequency denervation, and surgical fusion are often performed for pain relief. The aim of this work is To assess and compare the efficacy of ultrasound (US) guided intraarticular and periarticular SIJ injection with steroids (methylprednisolone) versus platelet-rich plasma (PRP) in relieving chronic SIJ pain and to assess the patient’s satisfaction, record any complications and deal with them accordingly.
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 Treatment: Drugs
Anticipated trial start date 10/01/2019
Actual trial start date 10/01/2019
Anticipated date of last follow up 31/07/2019
Actual Last follow-up date 15/08/2019
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 Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Platelet Rich Plasma 1.5 ml 0.5% bupivacaine + 2ml PRP + 0.5 ml PRP activator (calcium gluconate) Once US guided intraarticular SIJ injection of 1.5 ml 0.5% bupivacaine + 2ml PRP + 0.5 ml PRP activator (calcium gluconate) and periarticular injection of 1.5 ml 0.25% bupivacaine + 2ml PRP + 0.5 ml PRP activator (calcium gluconate). 25
Control Group Steroid 1.5 ml 0.5% bupivacaine + 1ml methylprednisolone (40mg/ml) + 1.5 ml normal saline and periarticular injection of 1.5 ml 0.25% bupivacaine + 1 ml methylprednisolone (40mg/ml) + 1.5 ml normal saline. Once US guided intraarticular injection of 1.5 ml 0.5% bupivacaine + 1ml methylprednisolone (40mg/ml) + 1.5 ml normal saline and periarticular injection of 1.5 ml 0.25% bupivacaine + 1 ml methylprednisolone (40mg/ml) + 1.5 ml normal saline. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with 3 or more positive provocative tests (sacral thrust, iliac distraction, iliac compression, thigh thrust, Patrick’s test, and Gaenslen’s test) OR Patients with positive radiological (X-ray or MRI) findings of SIJ inflammation plus at least 1 provocative test will be included in the study • Pregnancy. • History of intervertebral disc disease; Sciatica (low back pain with radiculopathy). • Zygapophyseal joint (facet joint) pain. • Spinal pathology; such as spondylolisthesis at L5/S1, scoliosis, or central canal stenosis. • Systemic infection or localized infection at the anticipated introducer entry site. • Immunocompromised patients. • Diabetes mellitus as a contraindication for steroid injection. • Contraindications to the use of platelet concentrate; such as thrombocytopenia, use of anticoagulant therapy, active infection, tumor, or metastatic disease. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 18/10/2018 Ethics Committee Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual Analogue Scale VAS Pre-injection, during the follow up period 2, 4, 6, 8 weeks and 4 months after injection
Secondary Outcome The Modified Oswestry Disability Questionnaire (MODQ) score Pre-injection, during the follow up period 2, 4, 6, 8 weeks and 4 months after injection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Clinic of Anesthesia and Surgical Intensive Care Department Faculty of Medicine Alexandria University Champollion st, El Azareta Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Yasmine Ragab El Sayed Mohamed 23 ElMosheer Street Sidi Gaber Alexandria 21523 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anesthesiology and Surgical Intensive Care Faculty of Medicine Alexandria University Champollion st, El Azareta Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Yasmine Ragab Elsayed Mohamed 23 elmosheer street sidi gaber Alexandria 21523 Egypt
Ahmed Saeed Aly Hassan okasha 17 Champllion street El Messalah Alexandria 21521 Egypt
Ahmed Mansour Ahmed Abdo 17 Champllion street El Messalah Alexandria 21521 Egypt
Akram Abdelmoneim Deghedy 17 Champllion street El Messalah Alexandria 21521 Egypt
Rabab saber Saleh Elsayed 17 Champllion street El Messalah Alexandria 21521 Egypt
Aly Mahmoud Moustafa Ahmed 17 Champllion street El Messalah Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Principal Investigator Ahmed okasha Saedokashaalex@gmail.com 00201223115046 17 Champollion Street El Messalah
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Anaesthesia and Surgical Intensive Care Faculty of Medicine Alexandria Univlersity
Role Name Email Phone Street address
Scientific Enquiries Ahmed Abdo am9277287@gmail.com 00201119277287 17 Champollion Street El Messalah
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Anaesthesia and Surgical Intensive Care Faculty of Medicine Alexandria Univlersity
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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