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.: PACTR201901523042787 Date of Approval: 16/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EPIDURAL STEROID INJECTION VERSUS INTERFERENTIAL CURRENT IN TREATMENT OF CHRONIC LOW BACK PAIN
Official scientific title EPIDURAL STEROID INJECTION VERSUS CONSERVATIVE MEASURES IN TREATMENT OF CHRONIC AXIAL LOW BACK PAIN: A RANDOMIZED PROSPECTIVE STUDY
Brief summary describing the background and objectives of the trial Chronic low back pain (LBP) is a very common disorder with various management strategies. There is still debate regarding management of axial LBP. So, we aimed to compare the effect of epidural steroid injection (ESI) plus exercises versus interferential current (IFC) plus exercises versus exercises alone in a prospective randomized controlled manner. Sixty patients complaining of chronic axial LBP were included and randomly assigned into either a group of ESI plus exercises (group A) or IFC plus exercises (group B) or exercises only (group C); each group was of 20 patients. Visual analogue scale (VAS) for pain, Oswestry disability index (ODI) for function and Beck's depression inventory (BDI) for depression were used for assessment of all participants; before treatment and at 3weeks, 6 weeks and 12 weeks after the start of treatment.
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 Treatment: Other
Anticipated trial start date 20/08/2017
Actual trial start date 01/09/2017
Anticipated date of last follow up 01/05/2018
Actual Last follow-up date 15/06/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 72
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 a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group blind epidural steroid injection plus exercises Epidural mixture consisted of triamcinolone acetonide 40 mg diluted in normal saline to a total volume of 10 ml, and injected into the epidural space (L2–L3 and L4–L5 interspace). (5 ml was injected at each site). one blind interlaminar epidural corticosteroid injections one blind interlaminar epidural corticosteroid injections in corresponding lumbar interspace using midline approach and 18-gauge Tuohy disposable needle inserted in the prone position. This procedure was carried out in the operating theater under complete aseptic precautions by the same physician; besides isometric strengthening exercises for the back and abdominal muscles 20
Experimental Group interferential current therapy plus exercises For 20 minutes; besides isometric strengthening exercises for the back and abdominal muscles; four sessions per week for three successive weeks (total of 12 sessions) two pole technique, amplitude modulation (Endomed 482, Enraf-Nonius BV, Rotterdam, The Netherlands).) 20
Control Group exercises four times per week three successive weeks isometric contractions of the lumbar multifidus and transversus abdominis. Static lumbar stability exercises were started with curl-up, pelvic bridge, side bridge, and quadruped positions. The intensity of exercises for each participant was controlled based on the exercise tolerance and pain thresholds 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients complaining of chronic axial LBP. patients aged between 20-65 years, BMI> 35 poor abdominal muscle power spinal nerve root compression presenting with sciatica spinal canal stenosis, multiple level disc prolapse, spondylolisthesis, previous spinal surgery, pre-existing neurologic deficits, uncontrolled psychiatric illnesses , polyneuropathy, generalized pain or any associated regional pain. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 65 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 17/08/2017 the ethics committee of the faculty of Medicine Alexandria university
Ethics Committee Address
Street address City Postal code Country
17 Champlion street, El Messalah Alexandria 02030 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome evaluation of pain using the Numerical Rating Scale (NRS), at three weeks, 6 weeks and 12 weeks after beginning of treatment
Secondary Outcome of function capacity using the Oswestry Disability Index (ODI), 3 weeks, 6 weeks and 12 weeks after start of treatment
Secondary Outcome evaluation of depression using the Arabic version of Beck's Depression Inventory (BDI). 3 weeks, 6 weeks and 12 weeks after start of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria university faculty of medicine Medaan El-Khartoom Square, Al-Azaritah, Alexandria 02030 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mayada Fawzy Medaan El-Khartoom Square, Al-Azaritah, Alexandria, Egypt Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mayada Fawzy Medaan El-Khartoom Square, Al-Azaritah, alexandria 02030 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Tarek Saad Shafshak Physical Medicine, Rheumatology and Rehabilitation Department, Faculty of Medicine, Alexandria University, Medaan El-Khartoom Square, Al-Azaritah., Egypt alexandria Egypt
Mazen Mohamed Fakhry Neurosurgery Department, Faculty of Medicine, Alexandria University,Medaan El-Khartoom Square, Al-Azaritah alexandria Egypt
Hoda Mohamed AbdelNaby Physical Medicine, Rheumatology and Rehabilitation Department, Faculty of Medicine, Medaan El-Khartoom Square, Al-Azaritah, Alexandria Egypt
Ahmed Rabie Abdelfadil Neurosurgery Department, Faculty of Medicine,Medaan El-Khartoom Square, Al-Azaritah Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mayada fawzy dr_mayada2007@yahoo.com 00201025738606 Medaan El-Khartoom Square, Al-Azaritah
City Postal code Country Position/Affiliation
Alexandria 02030 Egypt registerate
Role Name Email Phone Street address
Public Enquiries Hoda AbdelNaby hoda_naby@yahoo.com 00201227380883 Medaan El-Khartoom Square, Al-Azaritah
City Postal code Country Position/Affiliation
alexandria 02030 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Ahmed Abdelfadil dr_a_rabie@hotmail.com 00201002715340 Medaan El-Khartoom Square, Al-Azaritah,
City Postal code Country Position/Affiliation
alexandria 02030 Egypt lecturer
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