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.: PACTR202205801336085 Date of Approval: 18/05/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Fluoroscopic C-Arm guided versus Ultrasound guided therapeutic injection of lower cervical radiculopathies
Official scientific title Fluoroscopic C-Arm guided versus Ultrasound guided therapeutic injection of lower cervical radiculopathies
Brief summary describing the background and objectives of the trial This study aims to compare the mid-term therapeutic efficacy, safety and advantages of Ultrasound-guided selective cervical intra-tubercular nerve root block (SNRB) versus fluoroscopy-guided cervical interlaminar epidural block (CIEI) in lower cervical radiculopathies through assessment of pain relief and functional improvement.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Fluoroscopic C-Arm guided versus Ultrasound guided therapeutic injection of lower cervical radiculopathies
Anticipated trial start date 01/10/2020
Actual trial start date 01/10/2020
Anticipated date of last follow up 01/10/2021
Actual Last follow-up date 01/10/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
Publication URL FWA 000017585
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group cervical epidural injection Patients with cervical radiculopathy will be initially assessed and followed up at 2 weeks, 3 months and 6 months fluoroscopy-guided cervical interlaminar epidural block (CIEI) in lower cervical radiculopathies 30
Control Group Cervical injection Patients with cervical radiculopathy will be initially assessed and followed up at 2 weeks, 3 months and 6 months Ultrasound-guided selective cervical intra-tubercular nerve root block (SNRB) 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
60 patients with lower cervical radiculopathies confirmed by cervical MRI, not responding to conventional medical treatment 1. Patient will refuse or suffer from known allergies to contrast, dye or local anesthetics. 2. Pregnant, tumor or metastasis in the involved area of the spine. 3. Spinal instability or infections. 4. Active coagulopathy, severe systemic and metabolic conditions. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 70 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 29/08/2021 FMASU REC
Ethics Committee Address
Street address City Postal code Country
Abbasia cairo 11566 Egypt
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 29/08/2022 FMASU REC
Ethics Committee Address
Street address City Postal code Country
Abbasia Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome This study aims to compare the mid-term therapeutic efficacy, safety and advantages of Ultrasound-guided selective cervical intertubercular nerve root block (SNRB) versus fluoroscopic C-Arm guided cervical interlaminar epidural injection (CIEI) for lower cervical radiculopathies through assessment of pain relief and functional improvement. Patients with cervical radiculopathy will be initially assessed and followed up at 2 weeks, 3 months and 6 months
Primary Outcome relief of pain Patients with cervical radiculopathy will be initially assessed and followed up at 2 weeks, 3 months and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The outpatients of the ultrasonography unit of pain clinics of neurology and anathesia departments and fluoroscopic operating theatres of Ain Shams University hospitals Eastern Cairo, Egypt Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Mohamed Mahmoud ELHusseiny Nephia, Tanta, Gharbia Tanta 31742 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed ELHusseiny Nepha beside Nepha secondary school Tanta 31511 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Haitham Mohamed Hamdy Salem Haitham.hamdy@medasu.ed.eg +201002279912 Ain shams university
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Professor of Neurology
Role Name Email Phone Street address
Principal Investigator Nagia Ali Fahmy dr.nagiafahmy@med.asu.edu.eg +201001372015 Ain Shams University
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Professor of Neurology
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mohamed ELSadek ahmedelsadek_79@yahoo.com +201002414522 Ain Shams University
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Assistant Professor of Neurology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will individual participant data be available (including data dictionaries)? Yes What data in particular will be shared? Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) What other documents will be available? Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report, Analytic Code When will data be available (start and end date)? Immediately following publication, No end date With who? Anyone who wishes to access the data For what types of analyses? Any purpose By what mechanism will date be made available? Data are available indefinitely at (https://www.who.int/ictrp/results/en/), (Drelhusseiny87@yahoo.com) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Starting date in 1 octobar 2020 and end date in 1 octobar 2021 and IPD will be available Immediately following publication, No end date Will individual participant data be available (including data dictionaries)? Yes What data in particular will be shared? Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) What other documents will be available? Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report, Analytic Code When will data be available (start and end date)? Immediately following publication, No end date With who? Anyone who wishes to access the data For what types of analyses? Any purpose By what mechanism will date be made available? Data are available indefinitely at (https://www.who.int/ictrp/results/en/), (Drelhusseiny87@yahoo.com)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
(https://www.who.int/ictrp/results/en/), (Drelhusseiny87@yahoo.com) 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