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.: PACTR202302648824229 Date of Approval: 08/02/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluating the efficacy of local corticosteroid injection, platelet-rich plasma, and Extracorporeal shockwave therapy in patients with Pes Anserine bursitis
Official scientific title Evaluating the efficacy of local corticosteroid injection, platelet-rich plasma, and Extracorporeal shockwave therapy in patients with Pes Anserine bursitis
Brief summary describing the background and objectives of the trial Pes anserine bursitis is one of the causes of painful knee syndromes. It limits physical activity and impairs the quality of life of a patient. Obesity and osteoarthritis (OA) of the knee are common predisposing factors for pes anserine bursitis. It is treated with non-steroidal anti-inflammatory drugs (NSAIDs), physiotherapy, injections of local anesthetics, and corticosteroids. This study examines the efficacy of local corticosteroid injection, Platelet-rich plasma (PRP) injection, and extracorporeal shock wave therapy (ESWT) as different modalities to alleviate pain and improve function in patients with pes anserine bursitis.
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 01/06/2021
Actual trial start date 30/06/2021
Anticipated date of last follow up 01/05/2022
Actual Last follow-up date 05/05/2022
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 180
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group I local corticosteroid injection , Depo-Medrol 40 mg baseline local corticosteroid injection, platelet-rich plasma, and Extracorporeal shockwave therapy 60 Uncontrolled
Experimental Group Group II PRP injection Baseline PRP injection 60
Experimental Group Group III ESWT Baseline ESWT 60
Experimental Group Western Ontario and McMaster Universities pain score Western Ontario and McMaster Universities (WOMAC) pain score 8 weeks Western Ontario and McMaster Universities (WOMAC) pain score 60
Experimental Group Western Ontario and McMaster Universities physical function score Western Ontario and McMaster Universities physical function score after 8 weeks Western Ontario and McMaster Universities physical function score 60
Experimental Group Ritchie score for tenderness Ritchie score for tenderness after 8 weeks Ritchie score for tenderness 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients are clinically diagnosed with chronic pes anserine bursitis by a rheumatologist based on Larson and Baum's criteria: - Pain in the anteromedial area of the knee, especially when moving uphill or downstairs - Morning discomfort and stiffness lasting more than an hour - Nocturnal pain; and difficulty rising from a chair or getting out of a car. - Resistant to traditional treatments such as NSAIDs and Physiotherapy. - blood disorders - pacemakers - paresis of lower limbs - active malignancy or infection - pregnancy - fractures - having undergone knee surgery - Patients who declined to participate in the trial - those allergic to corticosteroid injections, - those suffering from fibromyalgia Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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
No 30/11/2022 Al Azhar University School of Medicine
Ethics Committee Address
Street address City Postal code Country
Al Azhar University Square Assiut 71524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Ritchie score for tenderness 8 weeks
Primary Outcome Western Ontario and McMaster Universities (WOMAC) pain score 8 weeks
Primary Outcome WOMAC physical function score 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Azhar University Al Azhar University Square Assiut 71524 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal Investigator Al Azhar University Square Assiut 71524 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al Azhar University Al Azhar University Square Assiut Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Wesam Gouda drwesamgouda@yahoo.com +201002753754 Al Azhar University Square
City Postal code Country Position/Affiliation
Assiut Egypt Rheumatology Department Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Tarek M AbdelAziz TarekMohamed.44@azhar.edu.eg +201093769458 Al Azhar University Square
City Postal code Country Position/Affiliation
Assiut Egypt Rheumatology Department Faculty of Medicine
Role Name Email Phone Street address
Principal Investigator Awad Abbas Awad.saad1980@gmail.com +201020907414 Al Azhar University Square
City Postal code Country Position/Affiliation
Assiut Egypt Rheumatology Department Faculty of Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Statistical Analysis Plan Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. The corresponding author email
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