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.: PACTR202401785557046 Date of Approval: 18/01/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Injection of Hyaluronic Acid versus Corticosteroid in Management of Plantar Fasciitis: Randomized Clinical Trial
Official scientific title Injection of Hyaluronic Acid versus Corticosteroid in Management of Plantar Fasciitis: Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Hyaluronic acid (HA) injections have been used to treat a wide range of joint disorders, including osteoarthritis. In recent years, HA has been associated with extended therapeutic indications in extra-articular areas such as plantar fascia and ligament injuries. The mechanism by which HA acts on enthesopathies remains poorly understood. Recently, a number of studies have investigated the efficacy of HA injections in treating plantar fasciitis. They have reported a beneficial effect of HA in these cases. However, most of these studies have been open pilot studies without a control group and have involved a small number of patients. Our study aims to investigate the efficacy of HA in patients suffering from plantar fasciitis. This product is believed to act through its potential analgesic and anti-inflammatory properties by inhibiting the growth of blood vessels and sensory nerves. Additionally, its lubricating properties are thought to prevent tissue adhesion. The primary objective of our study is to examine the superiority of HA over corticosteroids in reducing pain after 3 months in the treatment of plantar fasciitis. Secondary objectives include studying the tolerability and complications of HA in the treatment of plantar fasciitis.
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 04/03/2024
Actual trial start date
Anticipated date of last follow up 31/03/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Not yet 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 Injection of Hyaluronic Acid 20 mg/2ml Hyaluronic Acid + 1 ml 2% Lidocaine One time only The patient is positioned prone, with the knee extended, and the ankle in a neutral position. The injection will be performed under aseptic conditions, guided by ultrasound. A 22G needle will be inserted through the medial heel using the cross-section (in-plane technique) toward the target area (fasciitis plantaris thickening > 4 mm and/or abnormal hypoechoic areas in the fascia). Subsequently, 2 ml of hyaluronic acid (HA) will be injected using a single cutaneous penetration followed by several fascial penetrations. 25
Control Group Corticosteroid injection 40mg/ml for Methylprednisolone Acetate + 1 ml 2% Lidocaine one single injection The patient is positioned prone, with the knee extended, and the ankle in a neutral position. The injection will be performed under aseptic conditions, guided by ultrasound. A 22G needle will be inserted through the medial heel using the cross-section (in-plane technique) toward the target area (fasciitis plantaris thickening > 4 mm and/or abnormal hypoechoic areas in the fascia). Subsequently, 2 ml of corticoids will be injected using a single cutaneous penetration followed by several fascial penetrations 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age: 20 and 60 years Chronic talalgia (3 months), resistant to conservative treatment: rest, insoles, physical treatment (such as deep transverse massages, stretching, shock waves, etc.), and NSAIDs. Clinical diagnosis of PA: Pain initiated or aggravated by exertion and pain on palpation of the enthesis. Absence of fissures detected in ultrasound examinations. Visual Analog Scale (VAS) pain > 3/10 Plantar fascia surgery Shock waves within the last 3 months A corticosteroid or PRP injection in the last 3 months Bilateral plantar fasciitis Uncontrolled diabetes mellitus Chronic inflammatory rheumatism (spondyloarthritis) Tarsal tunnel syndrome Infection or local trauma near the injection site. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 30/11/2023 AC 49 NV 2023
Ethics Committee Address
Street address City Postal code Country
Rabat road Km 17 BP 398 Gzinaya Tangier 90100 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain intensity will be assessed by : The Visual Analogue Scale (VAS) Before injection - At 2 weeks - At 12 weeks - At 24 weeks
Secondary Outcome Function will be assessed by : Roles and Maudsley score and Functional Foot Index (FFI) Before injection - At 2 weeks - At 12 weeks - At 24 weeks
Secondary Outcome Ultrasound evaluation: Measurement of AP thickness / Absence of fissures Before injection - At 2 weeks - At 12 weeks - At 24 weeks
Secondary Outcome Patient satisfaction using Satisfaction likert scale At 2 weeks - At 12 weeks - At 24 weeks
Secondary Outcome Complications: Fissure/rupture, infection At 2 weeks - At 12 weeks - At 24 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mohammed VI University Hospital Center Rabat road Km 17 BP 398, Gzinaya Tangier 90100 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
ARUTA Rabat road Km 17 BP 398 Gzinaya Tangier 90050 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohammed VI University Hospital Rabat Road Km 17 BP 398 Gzinaya Tangier 90050 Morocco Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Nihad Takhrifa Nihadtakhrifa@gmail.com +212642286993 Residence Hamza Oued el Bahrain Floor 2 N14
City Postal code Country Position/Affiliation
Tangier 90100 Morocco Mohammed VI University Hospital
Role Name Email Phone Street address
Principal Investigator Fatima Ezzahra Abourazzak f.abourazzak@gmail.com +212661601814 Rabat road Km 17 BP 398 Gzinaya
City Postal code Country Position/Affiliation
Tangier 90050 Morocco Mohammed VI University Hospital
Role Name Email Phone Street address
Scientific Enquiries Fatima Zahrae Taik taikfatimazhrae@gmail.com +212664466928 Rabat road Km 17 BP 398 Gzinaya
City Postal code Country Position/Affiliation
Tangier 90050 Morocco Mohammed VI University Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Informed Consent Form Beginning 3 months and ending 5 years following article publication - Anyone who wishes to access the data - Any types of data analysis permitted - Process for requesting data/documents : Contact the principal invertigator -Criteria for reviewing requests : reasonable request
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