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: www.pactr.org
Trial no.: PACTR202004822698484 Date of Approval: 02/04/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Genicular nerve blockade for the treatment of chronic knee pain: a clinical study comparing the classical versus revised anatomical targets
Official scientific title A comparison of genicular nerve blockade using classical versus revised anatomical landmarks for painful knee osteoarthritis: a double-blind, randomized clinical study.
Brief summary describing the background and objectives of the trial Genicular nerve blockade (GNB) and radiofrequency ablation (RFA) have recently emerged as promising technique for the treatment of chronic knee pain. These methods are based on the principle that interrupting sensory nerve fibers to a painful structure may alleviate pain and restore function. Then, their success rely on the precise placement of the needle or cannulas, as close as possible to the consistent nerves supplying the knee joint capsule. However, an increasing number of anatomical studies and systematic reviews concluded that the anatomical basis for needle placement was unclear, incomplete and somewhat inaccurate. Because of much discussion about the accuracy of the current anatomical targets for genicular nerve blockade, recent studies have proposed more accurate revised targets. This study aims to compare the effectiveness of the two techniques for genicular nerve blockade in patients suffering from chronic knee pain. We hypothesize that, in patients with knee osteoarthritis, GNB using revised anatomical targets alleviate knee pain and improve knee function and the gait of patients more significantly than GNB using classical targets.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2019
Actual trial start date
Anticipated date of last follow up 01/06/2020
Actual Last follow-up date
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Genicular nerve Blockade using revised landmarks 0.5 ml of 1% Lidocaïne + 0.5 ml (20 mg) of Triamcinolone 40mg/ml single treatment The patient is placed in supine position on an radioluscent table, with a cushion in the popliteal fossa to slightly flex the treatment knee. Unser sterile conditions, local anesthetic is applied to the skin and subcutaneous tissues at each injection site. A 22-gauge cannula is inserted toward each of the anatomical targets under fluoroscopic guidance. After verification of proper needle placement, 0.5 ml of 1% Lidocaïne + 0.5 ml (20 mg) of Triamcinolone 40mg/ml is injected at each site. The revised procedure targets five nerves as follows 1. The superior lateral genicular nerve: the target is located at the junction between superior edge of the lateral femoral condyle and the posterior femoral cortex on the lateral view, and at the superior edge of the lateral femoral condyle on the A-P view 2. The superior medial genicular nerve: the target is located in front of the adductor tubercle (very posteriorly) on the lateral view, and at the superior edge of the medial femoral condyle on the A-P view. 3. The inferior medial genicular nerve: the target is the same for both techniques 4. The infrapatellar branch of the saphenous nerve: the target is a treatment longitudinal line connecting both following lines, 4cm medially to the patella apex: the transversal line passing by the apex patella and the transversal line passing by the tibial tuberosity. 5. The recurrent fibular nerve: the target is located at 1 cm longitudinally below the Gerdy’s tubercle. 30
Control Group Genicular nerve Blockade using classical landmarks 0.5 ml of 1% Lidocaïne + 0.5 ml (20 mg) of Triamcinolone 40mg/ml single treatment The patient is placed in supine position on an radioluscent table, with a cushion in the popliteal fossa to slightly flex the treatment knee. Unser sterile conditions, local anesthetic is applied to the skin and subcutaneous tissues at each injection site. A 22-gauge cannula is inserted toward each of the anatomical targets under fluoroscopic guidance. After verification of proper needle placement, 0.5 ml of 1% Lidocaïne + 0.5 ml (20 mg) of Triamcinolone 40mg/ml is injected at each site. The classical procedure targets three nerves as follows: 1. The superior lateral genicular nerve: the target is located at the confluence of the lateral femoral shaft and condyle in the anteroposterior (A-P) plane and at the midpoint of the femur in the lateral plane. 2. The superior medial genicular nerve: the target is located at the confluence of the medial femoral shaft and the condyle 3. The inferior medial genicular nerve: the target is located at the confluence of the medial tibial shaft and the tibial flare in the A-P plane and the midpoint of the tibia in the lateral plane 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Chronic knee pain (Numeric rating scale (NRS) >5/10, for more than three months); radiological tibio-femoral confirmation of knee osteoarthritis (Kellgren-Lawrence grade 2–4); and pain was not relieved by conservative treatment (oral medication, intra-articular injections with corticoids and viscosupplementation). Connective tissue diseases that affected the knee; skin lesion on the knee; steroid or hyaluronic acid injection therapy during the previous 3 months; knee surgery scheduled in the next three months; anticoagulant medication use; unbalanced diabetes mellitus or hypertension; patients unable to walk. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),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 21/05/2019 Cameroon Center Region Ethics Committee for Human Health Research approved the study protocol
Ethics Committee Address
Street address City Postal code Country
Rue de la delegation regionale de la sante du centre, Nlongkak yaounde Yaounde 0001 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in NRS score from baseline knee pain to 3 months after the treatment before treatment: baseline. After treatment: H1, H24, J7, J30, J90
Secondary Outcome - The proportion of subjects whose knee pain was reduced by 50% or greater from baseline at 3 months after treatment. - Change in knee function detected by OKS and WOMAC - Objective change in the locomotion as reflected by the walking speed on a 10 meter-track and the walking endurance assessed during a 6 minute free walking test - Analgesic use, as measured by subject self-reported quantitative analgesic questionnaire before treatment: baseline data. After treatment: H1, H24, J7, J30, J90
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre Hospitalier Dominicain Saint Martin De Porres Rue du centre saint martin de porres Mvogbetsi Yaounde Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Fonkoue Loic Rue de Santa Barbara Yaounde Cameroon
Olivier Cornu Avenue Mounier 53 Brussels 1200 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fonkoue Loic Rue de santa barbara, yaounde Yaounde 3911 Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
Olivier Cornu Avenue Mounier 53 Brussels 1200 Belgium
Eric Bandolo Rue du cradat Yaounde Cameroon
Julien Lebleu Avenue Mounier 53 Brussels 1200 Belgium
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fonkoue Loic fonkoueloic@yahoo.fr +237699666757 Rue de Santa Barbara
City Postal code Country Position/Affiliation
Yaounde Cameroon University of Yaounde 1
Role Name Email Phone Street address
Principal Investigator Olivier Cornu olivier.cornu@uclouvain.be +32475387566 Avenue Mounier 53
City Postal code Country Position/Affiliation
Brussels 1200 Belgium Catholic University of Louvain
Role Name Email Phone Street address
Public Enquiries Herman Fossoh hffossoh@yahoo.fr +237696393762 Rue du centre hospitalier saint martin de porres Mvogbetsi
City Postal code Country Position/Affiliation
Yaounde Cameroon Centre Hospitalier Dominicain saint Martin de Porres
Role Name Email Phone Street address
Public Enquiries Loic Fonkoue fonkoueloic@yahoo.fr +237699666757 Rue de Santa Barbara
City Postal code Country Position/Affiliation
Yaounde Cameroon University of Yaounde 1
Role Name Email Phone Street address
Scientific Enquiries Olivier Cornu olivier.cornu@uclouvain.be +32475387566 Avenue Mounier 53
City Postal code Country Position/Affiliation
Brussels 1200 Belgium Catholic University of Louvain
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the de-indentified individual participant data collected during the trial will be made available after the end of the study Clinical Study Report,Study Protocol Three months after article publication Co-authors' agreement
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
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided Clinical Study Report,Study Protocol
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
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 30/03/2020 Ethics letter received TRUE, Cameroon Center Region Ethics Committee for Human Health Research approved the study protocol, Rue de la delegation regionale de la sante du centre, Nlongkak yaounde, Yaounde, 0001, Cameroon, , 21 May 2019, 00237677944889, crersh_centre@yahoo.com, TRUE, Cameroon Center Region Ethics Committee for Human Health Research approved the study protocol, Rue de la delegation regionale de la sante du centre, Nlongkak yaounde, Yaounde, 0001, Cameroon, , 21 May 2019, 00237677944889, crersh_centre@yahoo.com, 10912_11209_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 30/03/2020 Recruitment is complete, but the assessment of the last patients has not yet been completed. Active, not recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 30/03/2020 Changed in accordance with the reviewers comments. Fonkoue Loic, Rue de Santa Barbara, Yaounde, , Cameroon, ,
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 30/03/2020 To comply with WHO requirements Undecided Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 30/03/2020 Not included in the previous application All the de-indentified individual participant data collected during the trial will be made available after the end of the study
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 30/03/2020 Not included in the previous application After article publication
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 30/03/2020 Not included in the previous application Co-authors' agreement
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 30/03/2020 Not included in the previous application Study Protocol, Clinical Study Report
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 30/03/2020 Changed after the explanations from reviewer Olivier Cornu, Avenue Mounier 53 , Brussels , 1200, Belgium, University,
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 30/03/2020 good address Olivier Cornu, Avenue Hippocrate 10, 1200 Brussels, Brussels, 1200, Belgium Olivier Cornu, Avenue Mounier 53, Brussels, 1200, Belgium
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 30/03/2020 Good adress Julien Lebleu, Avenue Hippocrate 10, 1200 Brussels, Brussels, 1200, Belgium Julien Lebleu, Avenue Mounier 53, Brussels, 1200, Belgium
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 30/03/2020 good address Scientific Enquiries, Olivier , Cornu, Prof., olivier.cornu@uclouvain.be, , +32475387566, Avenue Hippocrate 10, 1200 Brussels, Brussels, , Cameroon, Catholic University of Louvain Scientific Enquiries, Olivier , Cornu, Prof., olivier.cornu@uclouvain.be, , +32475387566, Avenue Mounier 53, Brussels, 1200, Belgium, Catholic University of Louvain
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 30/03/2020 Correction Public Enquiries, Loic, Fonkoue, Dr., fonkoueloic@yahoo.fr, , +237699666757, Rue de Santa Barbara, Yaounde, , Cameroon, University of Yaounde 1
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 30/03/2020 Correction Public Enquiries, Herman, Fossoh, Dr., hffossoh@yahoo.fr, , +237696393762, Rue du centre hospitalier saint martin de porres Mvogbetsi, Yaounde, , Cameroon, Centre Hospitalier Dominicain saint Martin de Porres Scientific Enquiries, Herman, Fossoh, Dr., hffossoh@yahoo.fr, , +237696393762, Rue du centre hospitalier saint martin de porres Mvogbetsi, Yaounde, , Cameroon, Centre Hospitalier Dominicain saint Martin de Porres
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 30/03/2020 Correction Scientific Enquiries, Olivier , Cornu, Prof., olivier.cornu@uclouvain.be, , +32475387566, Avenue Mounier 53, Brussels, 1200, Belgium, Catholic University of Louvain Principal Investigator, Olivier , Cornu, Prof., olivier.cornu@uclouvain.be, , +32475387566, Avenue Mounier 53, Brussels, 1200, Belgium, Catholic University of Louvain
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 30/03/2020 Correction Principal Investigator, Fonkoue , Loic, Dr., fonkoueloic@yahoo.fr, , +237699666757, Rue de nlongkak Yaounde, Yaounde, , Cameroon, University of Yaounde 1 Principal Investigator, Fonkoue , Loic, Dr., fonkoueloic@yahoo.fr, , +237699666757, Rue de Santa Barbara, Yaounde, , Cameroon, University of Yaounde 1
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 30/03/2020 Correction Scientific Enquiries, Olivier, Cornu, Prof., olivier.cornu@uclouvain.be, , +32475387566, Avenue Mounier 53, Brussels, 1200, Belgium, Catholic University of Louvain
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 30/03/2020 Correction Scientific Enquiries, Herman, Fossoh, Dr., hffossoh@yahoo.fr, , +237696393762, Rue du centre hospitalier saint martin de porres Mvogbetsi, Yaounde, , Cameroon, Centre Hospitalier Dominicain saint Martin de Porres Public Enquiries, Herman, Fossoh, Dr., hffossoh@yahoo.fr, , +237696393762, Rue du centre hospitalier saint martin de porres Mvogbetsi, Yaounde, , Cameroon, Centre Hospitalier Dominicain saint Martin de Porres
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 30/03/2020 Not included in the previous application After article publication Three months after article publication