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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201802002971380 Date of Registration: 14/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title SFEMG in CTS
Official scientific title Role of concentric needle Single Fiber Electromyography in detection of subclinical motor involvement in carpal tunnel syndrome
Brief summary describing the background and objectives of the trial Conventional motor nerve conduction studies are usually normal in early and mild carpal tunnel syndrome (CTS). Single Fiber Electromyography (SFEMG) measures the mean consecutive difference (MCD) as an expression of the variability in impulse transmission over the motor endplates and along the nerve fibers distally to the last branching point and along the muscle fibers. Study objectives: Application of concentric needle single fiber electromyography (SFEMG) in a group of CTS patients who showed pure sensory abnormalities in nerve conduction studies to examine for subclinical motor involvement
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied carpal tunnel syndrome,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 14/01/2015
Actual trial start date 14/01/2015
Anticipated date of last follow up 14/01/2015
Actual Last follow-up date 14/01/2015
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 60
Recruitment status Stopped early/ terminated
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group single fiber EMG in CATS patients 1 once single fiber EMG of the extensor digitorum communis, abductor pollicis brevis and abductor digiti minimi muscles 30
Control Group single fiber EMG in healthy patients 1 once single fiber EMG of the extensor digitorum communis, abductor pollicis brevis and abductor digiti minimi muscles 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
CTS patients with only sensory involvement proved by conventional nerve conduction studies other neuromuscular disorders, proven clinically or electrodiagnostically e.g. cervical radiculopathy, polyneuropathy patients with systemic diseases which may be associated with neuropathy e.g. diabetes mellitus patients in whom EMG examination is contraindicated e.g. bleeding disorders 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 05/01/2015 kasr alaini ethics committee of neurology and clinical neurophysiology department
Ethics Committee Address
Street address City Postal code Country
kasr alaini cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome SFEMG may be useful tool in detecting the abnormalities affecting the motor branches to the APB which are missed by conventional nerve conduction techniques at the early and mild stages of carpal tunnel syndrome after ending all the patients
Secondary Outcome establishing normative data values using concentric needle SFEMG for the APB, EDC and ADM muscles at the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
cairo university hospitals kasr alaini Cairo 020 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
cairo university university street Giza 020 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university university street Giza 020 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Aliaa Tawfeek 27 Nafezet Sheem El Shafaey St.¿ KASR EL AINY¿ Cairo Cairo 11562 Egypt
Amani Nawito 27 Nafezet Sheem El Shafaey St.¿ KASR EL AINY¿ Cairo Cairo 11562 Egypt
Amr Hassan 27 Nafezet Sheem El Shafaey St.¿ KASR EL AINY¿ Cairo Cairo 11562 Egypt
Lamiaa Afifi 27 Nafezet Sheem El Shafaey St.¿ KASR EL AINY¿ Cairo Cairo 11562 Egypt
Saly ElKholy 27 Nafezet Sheem El Shafaey St.¿ KASR EL AINY¿ Cairo Cairo 11562 Egypt
Radwa Azmy 27 Nafezet Sheem El Shafaey St.¿ KASR EL AINY¿ Cairo Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aliaa Tawfeek aliaa6610@gmail.com 01006210939
City Postal code Country Position/Affiliation
Giza Egypt Faculty of medicine-Cairo university
Role Name Email Phone Street address
Principal Investigator Aliaa Tawfeek aliaa6610@gmail.com 01006210939 27 Nafezet Sheem El Shafaey St.¿ KASR EL AINY¿ Cairo
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Faculty of medicine-Cairo university
Role Name Email Phone Street address
Public Enquiries Saly ElKholy elkholysaly@yahoo.com 01222286787 27 Nafezet Sheem El Shafaey St.¿ KASR EL AINY¿ Cairo
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Faculty of medicine-Cairo university
Role Name Email Phone Street address
Scientific Enquiries Amani Nawito amani.nawito@kasralainy.edu.eg 01006077405 27 Nafezet Sheem El Shafaey St.¿ KASR EL AINY¿ Cairo
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Faculty of medicine-Cairo university
REPORTING
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