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.: PACTR202202675152263 Date of Registration: 28/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound-Guided Diagnostic Block and Radiofrequency Ablation Technique for Sacroiliac Joint Pain
Official scientific title Ultrasound-Guided Diagnostic Block and Radiofrequency Ablation Technique for Sacroiliac Joint Pain
Brief summary describing the background and objectives of the trial The Sacroiliac (SI) joint is the largest axial joint in the body. It is most often characterized as a large, auricular-shaped, diarthrodial synovial joint. SIJ pain can present as a localized and/or referred pain. The most common complaints include pain in the lower back, buttocks, leg, groin, and hip. IA injections of SIJ with corticosteroids are often performed for pain relief. Image guidance of the SIJ injection seems to be important, due to the complex anatomy of the joint causing a low accuracy when performed according to clinical judgment only. The feasibility of ultrasound-guided injections of SIJs has been recently demonstrated resulting in very high success rates up to 90%. In the past several years, pulsed radiofrequency has emerged as a promising treatment alternative for refractory cases of sacroiliac joint pain The present study is conducted to evaluate the effectiveness of the Ultrasound-Guided Radiofrequency ablation technique and to compare its efficacy with local steroid injection for Sacroiliac joint pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/03/2022
Actual trial start date
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
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 Pulsed radiofrequency of Sacroiliac joint N/A 15 minutes After identification of the sacroiliac joint, US-guided, the 22 gauged 50-mm RF curved insulated cannula with a 10 mm active tip is advanced toward the center of the joint. After proper needle tip placement is confirmed, gentle aspiration is carried out and 2 milliliters of saline are injected to confirm needle position. The PRF probe is inserted inside the insulated cannula. PRF is applied with 42°C temperature and a pulse width of 20 milliseconds for 15 minutes then 4 milliliters of short-acting 2% lidocaine are injected intra-articularly under US guidance. 10
Control Group Steroid intrarticular Injection of Sacroiliac Joint 2 ml of Triamcinilone acetonide Once After Identification of the Sacroiliac joint, US-guided, a spinal needle is inserted intra-articular. After proper needle tip placement is confirmed, gentle aspiration is carried out and 2 milliliters of saline were injected to confirm needle position, then 2 milliliters of Triamcinolone acetonide is injected followed by injection of 4 milliliters of short-acting 2% lidocaine., under US guidance. 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Sacroiliac joint pain on history, at least 3 positive provocative tests. VAS pain score ≥ 3/10 refractory to oral anti-inflammatory and/or opioid analgesic therapy. BMI above 35 kg/m2. Ongoing litigation related to the patient’s pain, a diagnosis of severe anxiety or depression, allergy to local anesthetics or steroids, pregnancy, and multiple comorbidities. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 85 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 03/01/2022 Research ethics committee REC Faculty of Medicine Benha University
Ethics Committee Address
Street address City Postal code Country
Benha, Al-Sahaa Street, diverted from Farid Nada Street, Unique to Benha University Hospitals Benha 13518 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual Analogue Scale VAS Preintervention, 1 week, 3 weeks, 6 weeks
Secondary Outcome Oswestry Disability Index (ODI) Preintervention, 1 week, 3 weeks, 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical Research Institute Pain Outpatient clinic Department of Anaesthesia and Intensive care 165,El- Horreya Avenue, Al-Ibrahimeyah Qebli wa Al- Hadara Bahari, Qesm Bab Sharqi Alexandria 21561 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Raghdaa Mohsen Elsayed Eid 29,Mohamed Aly Street, Royal Tower above Royal care , Tanta Tanta 31512 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Institute Alexandria University 165,El- Horreya Avenue, Al-Ibrahimeyah Qebli wa Al- Hadara Bahari, Qesm Bab Sharqi Alexandria 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Gamal Abd ElGhaffar Hammad Al-Sahaa Street diverted from Farid Nada Street Benha University Hospitals Department of Rheumatology and Physical Medicine Benha 13518 Egypt
Refaat Moustafa Eltanawy Al-Sahaa Street diverted from Farid Nada Street Benha University Hospitals Department of Rheumatology and Physical Medicine Benha 13518 Egypt
Sahar Ahmed Elkaradawy 165 ElHorreya Avenue AlIbrahimeyah Qebli wa AlHadara Bahari Qesm Bab Sharqi Medical Research Institute Dpartment of Anaethesia and Intesive Care Alexandria 21561 Egypt
Waleed Ahmed Salah ElDeen AlSahaa Street diverted from Farid Nada Street Benha University Hospitals Department of Rheumatology and Physical Medicine Benha 13518 Egypt
Raghdaa Mohsen Elsayed Eid 29 Mohamed Aly Street Royal Tower above Royal care Tanta 13512 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 Waleed Salah ElDeen waleed22101979@yahoo.com 00201095000886 AlSahaa Street diverted from Farid Nada Street Benha University Hospitals, Department of Rheumatology and Physical Medicine
City Postal code Country Position/Affiliation
Benha 13518 Egypt Professor of Rheumatology and Physical Medicine Faculty of Medicine Benha University
Role Name Email Phone Street address
Scientific Enquiries Sahar Elkaradawy saharelkaradawy@yahoo.com 00201067940614 165,ElHorreya Avenue, AlIbrahimeyah Qebli wa AlHadara Bahari, Qesm Bab Sharqi Medical Research Institude Department of anaethesia and Intensive Care
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Professor of Anaesthesia and Pain Management Medical research Institute Alexandria University
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 an e-mail to elsayedamr@yahoo.com (public relations) 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