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.: PACTR201811567176951 Date of Registration: 30/11/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Laser Therapy Versus Electromagnetic Field on Mucosal Membrane Thickening in Children with Chronic Rhinosinusitis
Official scientific title Laser Therapy Versus Electromagnetic Field on Mucosal Membrane Thickening in Children with Chronic Rhinosinusitis
Brief summary describing the background and objectives of the trial Background: Rhinosinusitis is a frequent disease in children but could be under diagnosed. Numerous reasons of the disease are being missed in children. It’s essential to provide other modalities to treat chronic health conditions like such cases. So, This controlled clinical study was conducted to compare the effect of two non-pharmacological, painless and safe modalities; Low Level Laser Therapy (LLLT) against pulsed electromagnetic field (PEMF) on mucosal membrane thickening in children with chronic Rhinosinusitis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 07/03/2017
Actual trial start date 10/03/2017
Anticipated date of last follow up 20/04/2017
Actual Last follow-up date 25/04/2017
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Ethics committee, Faculty of Physical Therapy, Cairo University
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pulsed electromagnetic field 20 gauss for 10 minutes, 7Hz 1 month Each child in group A was placed comfortably in the seneloid of PEMF device, the device was switched on , selecting the appropriate program ( 20 gauss for 10 minutes, 7Hz), and this protocol of treatment was conducted 3 sessions/week, for one month. 15
Experimental Group Laser Therapy 1.5 J for all sinuses for 8 minutes this dose was divided on the eight sinuses, 6.12 Hz, 905 nm 1 month Each child in group B was placed in comfortable position, wear the protective eye glasses, then the device was switched on , the appropriate program was selected (1.5 J for all sinuses for 8 minutes this dose was divided on the eight sinuses, 6.12 Hz, 905 nm), and this protocol of treatment was conducted 3 sessions/week, for one month. 15
Control Group Medical treatment antibiotic and antihistamine 1 month they received the regular medical treatment for such case. 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
thirty children participated in this study; They were suffering from chronic rhinosinusitis as referred by physician, both gender were involved, their ages were from 6 to 13 years, They were selected from the Ear, Nose and Throat (ENT) Department of Kasr El –Aini teaching Hospital in Egypt. any immune-deficiency disorders or diseases that might interfere with the healing process and influence the results Adolescent: 13 Year(s)-17 Year(s),Child: 6 Year-12 Year 6 Year(s) 13 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 24/11/2018 Faculty of Physical Therapy. Cairo University
Ethics Committee Address
Street address City Postal code Country
Ahmed El-Ziat st. Giza 12611 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mucosal membrane thickness before starting the trial and after 1 month of trial
Secondary Outcome quality of life before starting the trial and after 1 month of trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University teaching hospital. Kasr El-Aini St. Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Authors Ahmed Elziat Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy. Cairo University Ahmed El-Ziat Giza 12611 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hamada Ayoub hamada.ayob@pt.cu.edu.eg +201220313532 Hadaek AlAhram
City Postal code Country Position/Affiliation
Giza 12556 Egypt Lecturer. Pediatric P.T deparment. Faculty of Physical Therapy. Cairo University. Egypt.
Role Name Email Phone Street address
Scientific Enquiries Nesrein Afify nessrien.afify@pt.cu.edu.eg +201143872680 Ahmed Al-Ziat
City Postal code Country Position/Affiliation
Giza 12611 Egypt Lecturer. Department of surgery. Faculty of Physical Therapy. Cairo University.
Role Name Email Phone Street address
Public Enquiries Dalia Mosaad drdaliamosaad@gmail.com +201001469096 Ahmed Al-Ziat
City Postal code Country Position/Affiliation
Giza 12611 Egypt Professor of Basic Science. Faculty of Physical Therapy. Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Thirty children suffering from CRS from both genders enrolled in the study, classified into two groups; group A (PEMF) consisted of 15 children (8 boys and 7 girls), the mean + SD for their ages was 6.47+3.23. While group B(LLLT) consisted of 15 children (9 boys and 6 girls), the mean + SD for their ages was 7.6+2.97. pre and post treatment measures of the mucosal membrane thickening (Mm) on right side for group (A) PEMF. The Wilcoxon matched pairs test revealed a significant reduction of mucosal membrane thickness between pre and post treatment values, as the median value of pre treatment was (0.5) and for post treatment was (0) where P-value was (0.02). Mucosal membrane thickening on right side pre and post treatment for group (B)LLLT. The Wilcoxon matched pairs test revealed a significant reduction of mucosal membrane thickness between pre and post treatment values, as the median value of pre treatment was (4) and for post treatment was (2.7) where P-value was (0.01). 29/11/2018 11/07/2018
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks P.T.REC/003/001735, 07/03/2017
Changes to trial information