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.: PACTR202109625368648 Date of Approval: 14/09/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of intraarticular combined injection of platelet-rich plasma and botulinum toxin versus platelet-rich plasma monotherapy for knee osteoarthritis: A randomized superiority trial
Official scientific title Efficacy of intraarticular combined injection of platelet-rich plasma and botulinum toxin versus platelet-rich plasma monotherapy for knee osteoarthritis: A randomized superiority trial
Brief summary describing the background and objectives of the trial Recent studies have worked on new non-surgical approaches for the management of knee osteoarthritis including intra-articular injection of hyaluronic acid, platelet-rich plasma (PRP), botulinum toxin, ozone therapy, and prolotherapy with different mechanisms of action and a varying degree of satisfactory relief of pain and improvement of function. To the best of our knowledge, there are no studies evaluating the efficacy of combined use of PRP and botulinum toxin in reducing pain and improving the function of painful knee OA. We hypothesize that combined intraarticular injection of PRP and botulinum toxin may be superior to PRP in reducing pain and improving function. The patients were randomly allocated to the PRP group and PRP plus botox group using computer-generated random numbers and sealed opaque envelopes. For any statistical tests used results will be considered statistically significant if P-value ≤0.05.
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 15/09/2021
Actual trial start date 26/12/2021
Anticipated date of last follow up 07/06/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Combined PRP and botulinum toxin injection 100 units of botulinum toxin and 3–4 cc of platelet-rich plasma with 2 ccs of 2% bupivacaine will be injected intraarticular in the knee joint. one injection PRP injection: For PRP preparation, a Y-CELL BIO KİT kit will be used. In this process, 13.5 ccs of blood will be taken from the antecubital vein using a G18 needle. Afterward, 1.5 ccs of acid citrate dextrose will be added as an anticoagulant. The blood sample will be centrifuged for 15 min at 4000 rpm, which results in three separate layers. The lower layer being RBC precipitate, the middle layer WBCs, and the top layer plasma. In the final stage, 3–4 cc of plasma remains in each tube. After disinfection, the ultrasound-guided suprapatellar recess approach be performed using G22 needles with the knee extended. After 15–20 min of rest, the patient will be asked to actively flex and extend their knee. Botulinum toxin injection: 100 units of botulinum toxin with 2 ccs of 2% bupivacaine will be injected intraarticular in the knee joint. 30
Control Group PRP injection 3–4 cc of platelet-rich plasma will be injected one injection For PRP preparation, a Y-CELL BIO KİT kit will be used. In this process, 13.5 ccs of blood will be taken from the antecubital vein using a G18 needle. Afterward, 1.5 ccs of acid citrate dextrose will be added as an anticoagulant. The blood sample will be centrifuged for 15 min at 4000 rpm, which results in three separate layers. The lower layer being RBC precipitate, the middle layer WBCs, and the top layer plasma. In the final stage, 3–4 cc of plasma remains in each tube. After disinfection, the ultrasound-guided suprapatellar recess approach be performed using G22 needles with the knee extended. After 15–20 min of rest, the patient will be asked to actively flex and extend their knee. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age of 40–70 years old Suffering from knee pain in the past six months History of complaints for at least one month The need for painkillers Knee osteoarthritis was confirmed by radiography (Kellgren-Lawrence classification grade 2–3). presence of systemic disorders (ie, diabetes mellitus, immunodeficiency, and collagen vascular diseases) the history of malignancy, the history of autoimmune diseases or platelet disorders, body mass index of over 33 kg/m2, the presence of IAIs within the past three months before the injection, the history of a recently occurred severe knee trauma, knee septic arthritis, the active ulcer or septic arthritis of the knee, genu varum or valgum of over 20°, history of clinically significant cardiac, hepatic, renal, or neurological dysfunction, coagulopathy, known allergy to study drugs Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 70 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 07/07/2021 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El Gohorria street Mansoura 35546 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The reduction of pain and an improvement of function after intraarticular injections 2weeks, one month, 2 months, and 6th months after the injection
Secondary Outcome patients’ satisfaction after 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospital 2 El-Gomhouria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university hospital 2 El-Gomhouria Street Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mahmoud Mohammed Alseoudy 2 El-Gomhouria Street Mansoura 35516 Egypt
Elsayed Mahmoud Elemam 2 El-Gomhouria Street Mansoura 35516 Egypt
Ibrahim Ibrahim Abdelbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Alseoudy drs3ody.mansora@mans.edu.eg +201006224551 2 ElGomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Elsayed Elemam sayedemam0606@gmail.com +201008765995 2 ElGomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Public Enquiries Ibrahim Abdelbasir ibrahimbaser2010@yahoo.com +201004976825 2 ElGomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will provide summary results or a link to summary results within the trial registration record Informed Consent Form Beginning 6 months and ending 12 months following article publication We will provide individual participant data and share it through the PubMed indexed journal
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