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.: PACTR202310697176998 Date of Approval: 25/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Study between Platelet-Rich Plasma, Corticosteroids and Perineural Dextrose local Injections for Treatment of Carpal Tunnel Syndrome
Official scientific title Comparative Study between Platelet-Rich Plasma, Corticosteroids and Perineural Dextrose local Injections for Treatment of Carpal Tunnel Syndrome
Brief summary describing the background and objectives of the trial Background: Carpal tunnel syndrome (CTS), one of the most common entrapment neuropathies, is considered as a socio-economic issue that reduces work productivity and increases disability. Objectives: to compare the effect of Platelet-Rich Plasma (PRP), corticosteroids (CS) and perineural Dextrose 5 % in water ( D5W) local injections for the treatment of idiopathic mild and moderate CTS.
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 Diagnosis / Prognosis
Anticipated trial start date 08/11/2017
Actual trial start date 10/12/2017
Anticipated date of last follow up 08/07/2021
Actual Last follow-up date 08/01/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Local corticosteroids once Reassessment after 3 months Ultrasound guided injection of 1 ml of Methyl prednisolone Acetate (as 40 mg of Depo-Medrone 40mg/ml) at the volar side of the wrist proximal to the wrist crease medial to the Palmaris longus tendon and the injection was given using 25 Gauge needle with angle of introduction 30- 40. 20
Experimental Group Perineural Dextrose injection once Reassessment after 3 months Ultrasound-guided with 5 ml of D5W using an in-plane ulnar approach at the proximal carpal tunnel inlet (ie, the scaphoid-pisiform level). A 3-ml injectate was used to remove the nerve from the flexor retinaculum via hydrodissection, and a residual 2-ml injectate was delivered to the inferior part of the median nerve for separation from the underlying subsynovial connective tissue and flexor tendon. After injection, the whole carpal tunnel was scanned to ensure that the injectate was distributed throughout the proximal-to-distal carpal tunnel 20
Experimental Group Platelet rich plasma injection Once Reassessment after 3 months ultrasound guided Platelet rich plasma injection:15 ml of whole blood was taken from the patient and it was added quickly to anticoagulant citrate dextrose solution in the centrifuge tube with a ratio 10:1. It was mixed gently then put in the centrifugation device. The apparatus was adjusted for double spin (The first was 1500 rpm for 15 mins to separate the erythrocytes, the second was 3500 rpm for 10 mins). The plasma obtained was of high concentration of platelets 4-5 times the average normal value found in the whole blood. One ml of Platelet rich plasma was collected by a 22 gauge syringe 3 cm and injected ultrasound-guided into the carpal tunnel. 20
Control Group NA NA NA NA 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients included in the study were diagnosed with mild and moderate idiopathic carpal tunnel syndrome With clinical symptoms for at least 3 months, and According to the electrophysiological studies classification of carpal tunnel syndrome into mild, moderate as follows: Mild CTS: Prolonged distal motor latency( DML) but less than 150% of the highest normal value (5.4 ms); Slowed sensory nerve conduction velocity (SNCV) but greater than 75% of the lowest normal value (30.1 m/s), Reduced compound muscle action potential (CMAP) or sensory nerve action potential (SNAP) amplitude but greater than 75% of the lowest normal value (CMAP: 3.9 mV, SNAP: 6.1 mV), Mildly increased polyphasic waves or duration of motor units action potential (MUAPs) in electromyography (EMG) tests. Moderate CTS: Prolonged distal latencies at the range of 150% to 200% of the highest normal value (5.4–7.2 ms), Slowed SNCV at the range of 50% to 75% of the lowest normal value (20–30 m/s), Reduced CMAP or SNAP amplitude at the range of 50% to 75% of the lowest normal value (CMAP: 2.5–3.8 mV, SNAP: 4.0–6.0 mV) Markedly increased polyphasic waves or duration of (MUAPs) in EMG tests. Patients with a history and symptoms consistent with: Severe carpal tunnel syndrome (wasting of thenar muscles) Cervical radiculopathy Thoracic outlet syndrome Brachial plexopathies Secondary CTS e.g.: Diabetes mellitus Rheumatoid arthritis Myxedema Acromegaly Pregnancy Oral contraceptive pills intake Fracture or dislocation of carpal bone Patient on chemotherapy or radiotherapy or cardiac drugs Peripheral median nerve trauma Patients with carpal tunnel syndrome who underwent surgical operation Patients with coagulation disorders, Seizure disorders and severe psychiatric illness Renal and liver impairment Skin diseases at site of injection. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 23 Year(s) 53 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 08/11/2017 Ain Shams University Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
56 Ramsis St., Abbasseya Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The result of this study may determine which treatment may be more beneficial for treatment of carpal tunnel syndrome Before injection and after 3 months
Secondary Outcome All of the three studied groups (corticosteroids, perineural dextrose and platelet rich plasma) have shown a great result regarding improving in clinical examination, clinical assessment scales, nerve conduction studies and improving in neuromuscular ultrasound results of carpal tunnel syndrome with favorable results of corticosteroids group over perineural dextrose group and platelet rich plasma group. Before injection and 3 months after
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ain Shams Faculty of medicine 56 Ramsis St., Abbasseya Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sarah Magdy Abbas Mohamed Ain Shams University Hospitals, El-Khalifa El-maamoun St. Abbassia, Cairo, Egypt. Cairo 11588 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Faculty of Medicine 56 Ramsis St., Abbasseya Cairo 11566 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sarah Magdy Abbas Mohamed 56 Ramsis St., Abbasseya Cairo 11566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sarah Magdy Abbas Mohamed dr.saramagdyabbas@gmail.com 01001630597 Ain Shams University Hospitals, El-Khalifa El-maamoun St. Abbassia, Cairo, Egypt.
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer of Rheumatology Rehabilitation and Physical Medicine
Role Name Email Phone Street address
Scientific Enquiries Mary Atef Nassif yan_rheum@med.asu.edu.eg 01006135348 Ain Shams University Hospitals, El-Khalifa El-maamoun St. Abbassia
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Rheumatology Rehabilitation and Physical Medicine
Role Name Email Phone Street address
Public Enquiries Sarah Sarah Magdy Abbas Mohamed dr.saramagdyabbas@gmail.com 01001630597 Ain Shams University Hospitals, El-Khalifa El-maamoun St. Abbassia
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer of Rheumatology Rehabilitation and Physical Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after de identification (text, tables, and figure) Analytic Code,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Researchers who provide a methodologically sound proposal, to achieve the aims in the approved proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 17/10/2023 21/06/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 17/10/2023 Result - 20/10/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://docs.google.com/document/d/1S3JyRcfZYJwLCCCr6LFGDnlr5rVb2HTt/edit?usp=sharing&ouid=105131762347206704633&rtpof=true&sd=true
Changes to trial information