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.: PACTR201902813618503 Date of Approval: 07/02/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Image guided pulsed RF in chronic lumbar radicular pain
Official scientific title Role of Image Guided Pulsed Radiofrequency of Lumbar Dorsal Root Ganglion in Management of Chronic Lumbar Radicular Pain
Brief summary describing the background and objectives of the trial Pulsed RF can be used without concern of producing sensory or motor loss. Since there is no satisfactory surgical solution for patients with chronic radicular pain or peripheral neuropathy, this mode of treatment offers a potentially valuable alternative to maintaining patients on chronic opiate therapy . The objectives of the trial evaluate the effectiveness of application of pulsed radiofrequency on lumbar dorsal root ganglion in management of chronic lumbar radicular pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/04/2019
Actual trial start date 01/04/2018
Anticipated date of last follow up 01/06/2019
Actual Last follow-up date 01/06/2019
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Closed to recruitment,follow-up continuing
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 Permuted block randomization 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 Radiofrequency Twice 2 cycles of pulsed RF administered to the DRG at 42°C for 120 s each. 20
Control Group Medical treatment NSAIDs:100-150 mg/d. Pregabalin: 150-600 mg/d. Carbamazepine: 400-800 mg/d from the start of the study till final assessment after 3 months Oral administration of: NSAIDs:100-150 mg/d. Pregabalin: 150-600 mg/d. Carbamazepine: 400-800 mg/d 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Chronic radicular pain, radiating down to the leg, resistant to conservative treatment and has no indication for open surgery. Magnetic resonance imaging showed evidence of mild to moderate nerve root compression. Absence of progressive motor defect. The radicular syndrome should have been present for at least 3 months, despite conservative treatment consisting of medication and physical therapy. The leg pain should be the primary complaint with an average pain score of at least 5 on the Numerical Rating Scale (NRS, 0 no pain and 10 the worst pain imaginable). Sepsis. 
 Coagulopathy. Patients with anatomical deformity or derangement, either congenital or acquired such as extreme scoliosis. Patients with cancer to account for their symptoms. Patients with known significant psychiatric history. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 14/03/2018 IRB Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Mesalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual Analogue scale (VAS) Before the procedure, at 2 weeks, 1 month and 3 months post-procedure.
Secondary Outcome The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) Before the procedure, at 2 weeks, 1 month and 3 months post-procedure.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Elhadara university hospital El-mostashfa el-italy street., elhadara, alexandria, egypt Alexandria 21581 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Shaaban Abd Elhady Abd ElMawla 17 Champollion Street, El Mesalah Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Orthopedics Surgery Faculty of Medicine El-mostashfa el-italy street., elhadara, alexandria, egypt Alexandria 21581 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sherif ElSayed Hegab 17 Champollion Street, El Mesalah Alexandria 21521 Egypt
Mohamed Ihab Samy Reda 17 Champollion Street, El Mesalah Alexandria 21521 Egypt
Sahar Ahmed ElKaradawy 165,elhorya street,el ebrahimia, alexandria. Alexandria 21561 Egypt
Mowaffak Moustafa Saad 17 Champollion Street, El Mesalah Alexandria 21521 Egypt
Omar Sameh Elaassar 17 Champollion Street, El Mesalah Alexandria 21521 Egypt
Shaaban Abd Elhady Abd ElMawla 17 Champollion Street, El Mesalah Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Hegab Sherif.Hegab.RD@gmail.com 00201005284937 17 Champollion Street El Messalah
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Radiodiagnosis Faculty of Medicine University of Alexandria Egypt
Role Name Email Phone Street address
Scientific Enquiries sahar Elkaradawy Sahar.Elkaradwy.Ana@gmail.com 00201067940614 165 Elhoryea Street Elhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Professor of Anesthesia and Pain Management Medical Research Institute University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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