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.: PACTR202204912139585 Date of Approval: 19/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Radiofrequency Ablation of Genicular Nerves in Chronic Knee Osteoarthritis: A Randomized Controlled Trial of Local Anesthetic versus a combination of Local Anesthetic and Corticosteroid to alleviate post procedural neuritis
Official scientific title Radiofrequency Ablation of Genicular Nerves in Chronic Knee Osteoarthritis: A Randomized Controlled Trial of Local Anesthetic versus a combination of Local Anesthetic and Corticosteroid to alleviate post procedural neuritis
Brief summary describing the background and objectives of the trial The aim of the study is to compare the effects of using a mixture of triamcinolone and bupivacaine versus bupivacaine alone to reduce the intensity and duration of post procedural neuritis, during fluoroscopic-guided radiofrequency ablation of genicular nerves in patients with chronic knee OA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Post Radiofrequency Neuritis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 10/06/2019
Actual trial start date 10/06/2019
Anticipated date of last follow up 10/07/2020
Actual Last follow-up date 01/07/2020
Anticipated target sample size (number of participants) 60
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Injection of the genicular nerves before radiofrequency 4 weeks A volume of 5 ml of the mixture (3 ml of bupivacaine 0.5% and 2 ml of normal saline) will be injected before the start of the RF; then, the electrode will be re-inserted through the cannula and tip temperature gradually raised up to 80 °C for 270 seconds (3 cycles of 90 sec.) 30 Active-Treatment of Control Group
Experimental Group Injection of the genicular nerves before radiofrequency 4 weeks A volume of 5 ml of the mixture (3 mls of bupivacaine 0.5% and 2mls (80 mg) of triamcinolone) will be injected before the start of the RF; then, the electrode will be re-inserted through the cannula and tip temperature gradually raised up to 80 °C for 270 seconds (3 cycles of 90 sec.) 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age between 50 and 80 years. • Presence of refractory knee pain of at least 3 months duration and at least grade 2 radiographic evidence of OA on the 5-point Kellgren–Lawrence scale. • Numerical Rating Scale (NRS) score at Day 1 ≥ 4 on chronic pain medication and ≥ 6 if not on chronic pain medication. • All patients should have a good response to the diagnostic genicular nerve block. • Acute knee pain, prior knee surgery, other connective tissue diseases that affected the knee. • Serious neurological or psychiatric disorders. • Steroid, hyaluronic acid injection therapy or electroacupuncture treatment during the previous 12 weeks. • Associated sciatic pain. • Anticoagulant medication use. • Pacemaker use. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 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 10/07/2019 Research Ethics Committee of Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine Abbassia Square Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduced or absent intensity of post radiofrequency neuritis with steroids 1 year
Secondary Outcome Any complication related to RF ablation such as infection, haemorrhage, thermal injury, loss of motor, and or sensory control in the corresponding area of the involved nerves 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals Abbasia square Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Saad Salah Aly Elfaioumy 3 High Street Bromley BR11AH United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospital Abbasia square Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Hesham Mohammed Elazzazi Heliopolis Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Elfaioumy ahmedsaad_elfaioumy@yahoo.com +447376477170 3 High Street
City Postal code Country Position/Affiliation
Bromley BR11AH United Kingdom Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries Ahmed Elfaioumy ahmedsaad_elfaioumy@yahoo.com +447376477170 3 High Street
City Postal code Country Position/Affiliation
Bromley BR11AH United Kingdom Assistant Lecturer
Role Name Email Phone Street address
Scientific Enquiries Ahmed Elfaioumy ahmedsaad_elfaioumy@yahoo.com +447376477170 3 High Street
City Postal code Country Position/Affiliation
Bromley BR11AH United Kingdom Assistant Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data that will underlie the results reported in this protocol after deidentification Study Protocol 9 months from April 2022 Investigators whose proposed use of the data has been approved by an independent review committee
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