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.: PACTR201611001878318 Date of Approval: 19/11/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title interlaminar versus transforaminal infraneural approach for treatment of lumbar disc herniation
Official scientific title A comparative study between interlaminar nerve root targeted epidural and infraneural transforaminal epidural steroids for treatment of intervertebral disc herniation.
Brief summary describing the background and objectives of the trial Low back pain is increasing at an uncontrollable rate, and is the number one contributor to most years lived with a disabilityTransforaminal epidural steroid injections (TFES) and interlaminar epidural steroid injections(ILESI) are commonly performed procedures for the management of unilateral lumbosacral radicular pain (LSRP). By definition, an interlaminar injection is an approach to the dorsal epidural space going through the space between the lamina of the vertebrae. A transforaminal injection is an approach toward the epidural space via the intervertebral foramen where the spinal nerves exit. As regard transforaminal injection we frequently wondered whether TFESI should be performed at the neural foramen near the exit zone of the compressed nerve root (eg, at the L5-S1 neural foramen for an L5 nerve root compressed at the L4-5 disk) or at the neural foramen near the compression level .The infraneural approach known as kambin triangle approach which is a right triangle overlying the dorsolateral disc, in which the hypotenuse of the tri-angle is the exiting nerve, the base is the caudad vertebral body, and the height is the traversing nerve root (Kambin P,2000). the purported advantage of TFESI over ILESI is attributed to enhanced deposition of medication in closest proximity to the pain generators found in the ventral epidural space(Lutz GE,1998).and hence reaching the targeted pain generators with a smaller dose of medication. We hypothesis that the this new technique for ILES may be beneficial in achieving rapid painrelief like with TFESI and more durable and better functional improvement . Aim of the work The aim of our study is to compare between the efficacy of infraneural transforaminal epidural steriod injection and lumbar paramedian interlaminar steriod injection in reduction of low back pain in unilateral radiculer pain secondary to disc proloapse.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IL vs Infraneural TF
Disease(s) or condition(s) being studied Low back pain,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 04/10/2015
Actual trial start date 13/12/2015
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date 20/11/2016
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
MS/15.9.45 ocal ethical committee /Mansoura faculty of medicicne
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 randomisation using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group interlaminar nerve root targeted epidural 2ml ( 80 mg) of depomedrol plus 4 ml of bupivacaine 0.125 % plus 4 ml of normal saline 0.9 percent in a total volume of 10 ml. once For the paramedian approach, the fluoroscopic centering and squaring of the targeted vertebra will be achieved with appropriate craniocaudal tilting of the C-arm. Then, a 18 G 3.5 inch Tuohy epidural needle will be inserted at the midpoint of the interlaminar space with a slight lateral direction toward the paramedian epidural area near the most affected nerve root. The selected nerve root will b 20
Experimental Group Retrodiscal transforaminal 2ml ( 80 mg) of depomedrol plus 3 ml of bupivacaine 0.12 % in a total volume of 5 ml once approach the targeted nerve root will be determined and the fluoroscopy will be directed in the AP ( anteroposterior) view before obtaining the trajectory view. A caudad or cephalad tilt is used to line up both the superior endplate (SEP) and the inferior endplate (IEP) ofthe adjacent lumbar vertebrae. (Preferentially line up the SEP interior to the target.) The C-arm is then obliqued approximat 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
single level or multi- level lumbar disc protrusion with leg radiation of minimum 4 weeks duration unrelieved by conventional treatment as well as physiotherapy 1. Patients with a history of backache without leg radiation, 2. Previous spine surgery, 3. LESI in the past months 4. Allergy to the drugs used, 5. Concurrent use of systemic steroid medications, 6. Opioid addiction 7. Pregnancy. 8. and patients with any neurological deficit will be excluded. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 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 12/12/2015 IRB Mansoura faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Elgmhoria street Elmansourah 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome effective pain relief (¿60% from baseline) 1 hour after the procedure 1 day every month for a duration of 6 months after the procedure .
Secondary Outcome . Functional improvement by Modified Oswestry Disability Questionnaire (MODQ) 2 weeks, 1 month, 2 months, 3 months and 6 months after the procedure.
Secondary Outcome Incidence of possible complications anytime
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansourah university hospital , Mansourah university . Elgmhoria street ElMansourah 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura University hospitals Elgmhoria street Elmansourah 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University hospitals Elgmhoria street ElMansourah 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Alaa-Eldin Adel El Maadawy Elgmhoria street ElMansourah 35516 Egypt
Mohamed El Metwally Mansour Elgmhoria street ElMansourah 35516 Egypt
Prof.Ashraf Abd EL Moneim El Metwally Elgmhoria street ElMansourah 35516 Egypt
Ayman Mohamed Abd El Naby Elgmhoria street ElMansourah 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mansour drmohamedmetwally@hotmail.com 00201008872766 Elgomhoria Street
City Postal code Country Position/Affiliation
Elmansoura 35516 Egypt resident in neurology
Role Name Email Phone Street address
Public Enquiries alaa eldin Elmaadawy a_maadawy@hotmail.com 00201153304999 Elgomhoria street, Anesthesia department,mansoura university hospitals.
City Postal code Country Position/Affiliation
Elmansoura 35516 Egypt Lecturer in anesthesia , pain management
Role Name Email Phone Street address
Scientific Enquiries alaa eldin Elmaadawy a_maadawy@hotmail.com 00201153304999 Elgomhoria street, Anesthesia department,mansoura university hospitals.
City Postal code Country Position/Affiliation
Elmansourah 35516 Egypt Lecturer in anesthesia , pain management
REPORTING
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