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.: PACTR202308825168287 Date of Approval: 18/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Platelet-Rich Plasma (PRB) combined with Medial Calcaneal Nerve Block in patients with planter fasciitis
Official scientific title Effect Of Combined Medial Calcaneal nerve Block and platelet rich plasma for planter fascitis
Brief summary describing the background and objectives of the trial Local PRP injections are an emerging treatment modality in the management of chronic tendon and ligament pathologies, including plantar fasciitis. The theory behind PRP treatment is that an injection of large doses of growth factors, cytokines and cellular contents into soft tissue will promote cellular proliferation and possibly regeneration. An injection of PRP directly at the site of tenderness within the plantar fascia allows these contents to reach an area that is otherwise relatively inaccessible due to its hypo vascularity (Martinelli et al., 2013). Recently In chronic pain management, interruption of nociceptive transmission produces pain relief. Medial calcaneal nerve (MCN), a branch of the posterior tibial nerve provides sensory innervation in heel and its Antero medial aspect. It is anticipated that blocking the MCN near its origin could possibly have a role in managing pain in patients of PF (Thapa and Ahuja, 2014). The study aim to compare and evaluate effect of addition of ultrasound guided medial calcaneal nerve block to Platelet Rich Plasma (PRP) vs (PRP) for treatment of planter fasciitis Primary outcome is Measurement of pain intensity using visual analog scale (VAS), Secondary outcomes are Measurement of Functional Limitation using Foot Function Index (FFI) and Patient satisfaction using (modified criteria of the Roles and Maudsley score)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 25/06/2022
Actual trial start date 30/06/2022
Anticipated date of last follow up 21/06/2022
Actual Last follow-up date 30/06/2023
Anticipated target sample size (number of participants) 70
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PRP with MCNB 3 mL of PRP will be obtained from the “buffy coat” for injection. n (0.5 ml of 2% lignocaine and 0.5 ml of 0.5% bupivicaine) one injection and follow-up 2-, 4-, 12-, and 16-weeks To prepare the PRP 27 mL of venous blood will be obtained from each participant and mixed with 3 mL of anticoagulant citrate. • The blood will be centrifuged for 12 minutes. 3 mL of PRP will be obtained from the “buffy coat” for injection. We will decide to perform the MCN block near its origin rather than inside the flexor retinaculum to avoid direct heel puncture, atrophy of heel pad and plantar fascia rupture • This site will be marked as 'X' on skin for MCN block. • Under aseptic precautions, 1.0 ml solution (0.5 ml of 2% lignocaine and 0.5 ml of 0.5% bupivicaine) of local anesthetic will be injected under ultrasound guidance. 35
Control Group PRP 3 mL of PRP will be obtained from the “buffy coat” for injection. one injection and follow-up 2-, 4-, 12-, and 16-weeks To prepare the PRP 27 mL of venous blood will be obtained from each participant and mixed with 3 mL of anticoagulant citrate. • The blood will be centrifuged for 12 minutes. 3 mL of PRP will be obtained from the “buffy coat” for injection. 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Cases with six-months minimum of conservative therapies, such as icepacks, stretching of the Achilles tendon and NSAID medication, which provided inadequate improvement of pain and function • Other associated pathologies (alterations in ipsilateral ankle and knee, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, Reiter’s syndrome). • Neurological abnormalities. • Skin infections. • History of infection at the application site (within the previous three months). • Coagulopathies such as Hemophilia, Von Willebrand disease, clotting factor deficiencies, hypercoagulable states and deep venous thrombsis . Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 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
Yes 05/06/2022 Medical Research Ethics Committe Institutional Review Board Mansoura faculity of medicine Mansoura university
Ethics Committee Address
Street address City Postal code Country
Institutional Review Board Bulding A - Faculty of medicine mansoura university Mansoura Dakahlia Governorate 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome is Measurement of pain intensity using visual analog scale (VAS). 4 months
Secondary Outcome Secondary outcomes are Measurement of Functional Limitation using Foot Function Index (FFI) and Patient satisfaction using (modified criteria of the Roles and Maudsley score) 4 monthes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospitals El Gomhouria Street, Mansoura Dakahlia Governorate mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura University Hospital El Gomhouria Street, Mansoura Dakahlia Governorate Mansoura Dakahlia Governorate 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Hospitals El Gomhouria Street, Mansoura Dakahlia Governorate Mansoura Dakahlia Governorate 35511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abd Elrhman Salama salama.body11@yahoo.com +201008654191 El Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Resident
Role Name Email Phone Street address
Scientific Enquiries Elsayed Elemam sayedemam5@mans.edu.eg +201008765996 El Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt associate professor
Role Name Email Phone Street address
Public Enquiries Ghada El Rahmawy aslany.salama@gmail.com +201550434587 El Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data that will be shared is individual participant data that underlie results reprted in this article after deidentification (text,Tables and figures) Informed Consent Form Begining 6 months and ending 12 months following article publication we will provide individual participant data and share it through 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