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.: PACTR202301832676408 Date of Approval: 25/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Radiofrequency ablation of genicular nerve versus intra-articular botox injection for knee osteoarthritis pain
Official scientific title Radiofrequency ablation of genicular nerve versus intra-articular botox injection for knee osteoarthritis pain; a randomized single blinded study.
Brief summary describing the background and objectives of the trial Osteoarthritis of the knee (KOA) is the most common debilitating joint disorders and a leading cause of pain and disability worldwide Knee osteoarthritic pain can be managed by many pharmacological and interventional therapeutic modalities; each entails a number of concerns. Use of common therapies such as nonsteroidal anti-inflammatory drugs (NSAIDs), Intra-articular corticosteroid injection is associated with significant adverse events in some patients. Radiofrequency (RF) genicular neurotomy is a means of inducing analgesia in patients with chronic knee pain due to OA who fail to respond to conservative treatment. It is an effective, minimally invasive method for the treatment of chronic knee OA pain and loss of function . Botulinum toxin (BTX) decreases the production of substance P and other pain generator substances through attaching to C fibers. Intra-articular BTX injection is proposed to manage resistant joint pains and has shown some encouraging results. To the best of our knowledge, there is no previous studies comparing ultrasound guided genicular neurotomy versus intraarticular botox injection in the management of knee osteoarthritis.  
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied analgesia for chronic osteoarthritis.
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 07/09/2022
Actual trial start date 31/01/2023
Anticipated date of last follow up 31/07/2023
Actual Last follow-up date 27/05/2024
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Radiofrequency ablation of genicular nerves. • 20 msec pulse width and a 2 Hz frequency at 42°C for 120 second duration applied twice for each nerve, . total of 12 minutes. under ultrasound guidance. radiofrequency ablation of the genicular nerve will be carried out using 20 msec pulse width and a 2 Hz frequency at 42°C for 120 second duration applied twice for each nerve, .. 30 Uncontrolled
Experimental Group knee intraarticular Botox injection The medial approach will be the preferred method of injection, when the patient lies in supine position, botox will be administered via intraarticular injection of . 50 u. one injection Knee intraarticular injection of Botolinum toxin A 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients with chronic primary knee osteoarthritis. • Age > 40 years. • Failure to respond to other non-interventional therapies (physical therapy and rehabilitation, oral NSAIDs). • Grade III – IV according to the Kellgren-Lawrence Grading Scale on a documented radiological study. • Secondary osteoarthritis. • Body mass index (BMI) > 35 kg/m2. • Ongoing psychiatric illness. • Presence of infections at the injection site. • Malignancy. • Coagulopathy or use of anticoagulants. • History of rheumatological disorders, prolotherapy, or intraarticular injection in the three months. • History of trauma within 3 months before the study. • Presence of an indication for arthroplasty. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 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 04/04/2021 MFM IRB
Ethics Committee Address
Street address City Postal code Country
al Gomhoria street Mansoura 35511 Egypt
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 31/12/2022 MFM IRB
Ethics Committee Address
Street address City Postal code Country
Al Gomhoria Mansoura 53311 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Improvement in pain (VAS) for 6 months after therapy 1, 3, and then after 6 months after the procedure
Secondary Outcome The patient will be followed up for 6 months after procedure • Procedural complications. • Patient satisfaction 1, 3, and then after 6 months after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University hospital El Gomhoria street Mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self Al Gomhoria Mansoura 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University hospitals Al Gomhoria street Mansoura 35511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elsayed Elemam sayedemam0606@gmail.com 01008765995 Algomhoria street
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt assistant professor
Role Name Email Phone Street address
Public Enquiries Ibrahim Abdelbaser ibrahimbaser2010@yahoo.com 01004976825 Algomhoria street
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Samah Elkenany sk_20022000@yahoo.com 00201002262557 Hay El Gamaa street
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt assistant professor
Role Name Email Phone Street address
Public Enquiries Khalid elbahrawy Khali_bahrawy@gmail.com 00201067240357 Algomhoria street
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt assistant professor
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) Statistical Analysis Plan,Study Protocol Immediately following publication, No end date . open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not applicable 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