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Trial registered on ANZCTR


Registration number
ACTRN12612001186842
Ethics application status
Approved
Date submitted
6/11/2012
Date registered
12/11/2012
Date last updated
10/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of combined use of Low Intensity Laser Therapy and Ultraviolet Radiation in the treatment of Relapsing-Remitting Multiple Sclerosis patients
Scientific title
Efficacy of combined use of Low Intensity Laser Therapy and Ultraviolet Radiation on limiting the pathogenic process, improving cerebral haemodynamics and neurophysiological functions in Relapsing-Remitting Multiple Sclerosis patients
Secondary ID [1] 281499 0
None
Universal Trial Number (UTN)
U1111-1136-7366
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis 287769 0
Condition category
Condition code
Neurological 288116 288116 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Biostimulation Low Intensity laser therapy (LILT) Scanner device (850 nm, 400 mW, 4 J/cm2) on the cervical region for 10 minutes, once every other day for 12 sessions (4 weeks). in addition to traditional drug therapy for Multiple sclerosis (MS).

and

Ultraviolet Radiation (UV)with a broad band Ultraviolet B class (UVB) device (280- 315 nm) will be used to deliver UV radiation on the whole back and neck regions from 50 cm distance and for 10 minutes, once every other day for 12 sessions (4 weeks). in addition to traditional drug therapy for Multiple Sclerosis (MS) .

The Range of broad band UVB wave length is (280- 315 nm), which is fixed range in all broad band UVB devices. as for the dose used in this study it would be determined according to the Minimal Erythema Dose (MED) which is a pretreatment test for erythema caused by the exposure to ultraviolet radiation. we would start with a dose equal to 50% of the MED- that would differ from one patient to another- then we would increase 10% of MED each successive session. As to keep the treatment dose at the sub-erythemal level for all patients.

There will be 3 study groups :

1- Laser group
2- Ultraviolet (UV) group
3- Laser + UV group
Intervention code [1] 286013 0
Treatment: Devices
Comparator / control treatment
Randomized controlled study, the control group would receive only the traditional Multiple sclerosis drug therapy (Immuno-supressant drug [Steroid (Solu-medrol) 1 mg intravenous injection- once per month]) for the control of patients on remission stage of the disease, the drug would be used before the enrollment and after the end of our treatment program because of the chronic nature of the disease ( the duration of drug therapy is related to the disease course not related to the study time). they will be tested soon after allocation and retested twice (after one month and after another 3 months).
Control group
Active

Outcomes
Primary outcome [1] 288320 0
Expanded disability Status Scale (EDSS)
Timepoint [1] 288320 0
Pretreatment, post treatment (right at the end of the treatment program), 3 months after the end of the treatment program
Primary outcome [2] 288321 0
Electroneurography (Evoked potentials) device will be used to pick up the Evoked potentials (Visual, Auditory, Somatosensory)
Timepoint [2] 288321 0
Pretreatment, post treatment (right at the end of the treatment program), 3 months after the end of the treatment program
Primary outcome [3] 288322 0
Transcranial Doppler to assess total cerebral blood volume
Timepoint [3] 288322 0
Pretreatment, post treatment (right at the end of the treatment program), 3 months after the end of the treatment program
Secondary outcome [1] 299846 0
Electromyogram (EMG) test for H- Reflex
Timepoint [1] 299846 0
Pretreatment, post treatment (right at the end of the treatment program), 3 months after the end of the treatment program
Secondary outcome [2] 299847 0
The serum level of 25-hydroxyvitamin D3 [25(OH)D3] (Calcidiol) will be assessed through laboratory blood test.
Timepoint [2] 299847 0
Pretreatment, post treatment (right at the end of the treatment program).

Eligibility
Key inclusion criteria
During remission state, regardless of the duration of MS established diagnosis, but having not more than (6) on EDSS scale.


They are Free from any systemic vascular or blood disease, vasculitis, diabetes, liver disease, kidney failure, heart failure, traumatic brain injury (TBI), cerebrovascular accident (CVA), spinal cord injury, human immunosuppressive virus (HIV), hyperthyrodism, cancer or in risk of chemical or atomic radiation exposure.
Minimum age
25 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If any patient develop an allergic reaction to phototherapy or passed into an Multiple Sclerosis relapse would be excluded from the study.


Patients who will miss more than 3 successive sessions would be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered container
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization, by allocating the first patient to participate in group (1) the second patient to group (2) third patient to group (3) forth patient to group (4). then start allover again the next patient to group (1) and so on.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 4671 0
Egypt
State/province [1] 4671 0
Cairo

Funding & Sponsors
Funding source category [1] 286281 0
Self funded/Unfunded
Name [1] 286281 0
Shimaa Abdelalim Essa
Country [1] 286281 0
Egypt
Primary sponsor type
Individual
Name
Shimaa Abdelalim Essa
Address
41 Ahmed Kasem Jodah Street, Nasr city, Cairo.

Area: Rabaa Eladawia post office /Nasr city

Postal code: 11759
Country
Egypt
Secondary sponsor category [1] 285074 0
University
Name [1] 285074 0
Cairo University
Address [1] 285074 0
Cairo University- Ben Elsarayat Street, Al Jezah city


Postal code: 12613
Country [1] 285074 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288351 0
National Institute of Enhanced Laser Science- Cairo University
Ethics committee address [1] 288351 0
Cairo University- Ben Elsarayat Street, Al Jezah city


postal code: 12613
Ethics committee country [1] 288351 0
Egypt
Date submitted for ethics approval [1] 288351 0
07/10/2012
Approval date [1] 288351 0
05/11/2012
Ethics approval number [1] 288351 0

Summary
Brief summary
in our study we would investigate the efficacy of combined Ultraviolet Radiation (UVR) on the whole back and Low Intensity Laser Therapy (LILT) paravertebrally over the cervical region’s vertebral veins and arteries) treatment regimen on improving total cerebral blood flow (Transcranial Doppler), limiting the pathogenic process of relapsing-remitting multiple sclerosis (blood test for vitamin D), neurophysiological functions (Evoked potentials studies) of the central nervous system (CNS) and after all improving the well being of MS patients (Expanded Disability Status Scale EDSS).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34921 0
Address 34921 0
Country 34921 0
Phone 34921 0
Fax 34921 0
Email 34921 0
Contact person for public queries
Name 18168 0
Shimaa Abdelalim Essa
Address 18168 0
41 Ahmed Kasem Jodah Street, Nasr city- Cairo.

Area: Rabaa Eladawia post office /Nasr city

Postal code: 11759
Country 18168 0
Egypt
Phone 18168 0
002-0122-3721631
Fax 18168 0
Email 18168 0
[email protected]
Contact person for scientific queries
Name 9096 0
Shimaa Abdelalim Essa
Address 9096 0
41 Ahmed Kasem Jodah Street, Nasr city- Cairo.

Area: Rabaa Eladawia post office /Nasr city

Postal code: 11759
Country 9096 0
Egypt
Phone 9096 0
002-0122-3721631
Fax 9096 0
Email 9096 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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