Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001025628
Ethics application status
Approved
Date submitted
6/09/2014
Date registered
24/09/2014
Date last updated
20/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of Phototherapy on the modification of Fatigue and Cognitive functions for patients with Relapsing Remitting Multiple Sclerosis.
Scientific title
The Impact of Photobiostimulation by low level laser therapy and Broad Band Ultraviolet B Radiation on Fatigue and Cognitive Functions of Patients with Relapsing Remitting Multiple Sclerosis.
Secondary ID [1] 285296 0
NIL
Universal Trial Number (UTN)
U1111-1161-3997
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigue caused by Multiple sclerosis 292964 0
Stress reaction tolerance (cognitive function), of patients with Multiple sclerosis 292965 0
Multiple Sclerosis 293079 0
Condition category
Condition code
Neurological 293258 293258 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 293259 293259 0 0
Physiotherapy
Mental Health 293260 293260 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group (2) -- Broad Band Ultraviolet B Radiation, BB-UVBR (280-320 nm) with a radiant power = 0.396 W/cm2, and total sub-erythemal dose = 470 mJ/cm2 on the whole back region from 100 cm distance perpendicularly , for 20 minutes (starting at 50% of the total dose (235 mJ/cm2˜ 10 minutes for the first session), with an incremental increase of 10% of the total dose (47 mJ/cm2˜ one minute increase/ session), session 3 days/week (4 weeks) for 12 sessions.
Intervention code [1] 290199 0
Treatment: Devices
Comparator / control treatment
Group (1)--- Low Level Laser Therapy, GaAlAs diode Scanner laser, emitting near infrared wavelength (NIR) 850 nm, Pulsed wave (PW); pulse duration (PD) 50 ns (nanoseconds), frequency 2084 Hz, maximum power (Pmax) 10 W, average power (AP) 0.00104 W. Radiant power 0.00208 W/cm2, Radiant energy (Q) 2 J, Radiant exposure (E/a)act 4 J/cm2) on the cervical region for 10 minutes, session 3 days/week (4 weeks) for 12 sessions. .
Control group
Active

Outcomes
Primary outcome [1] 293109 0
Fatigue severity, using the Fatigue Severity Scale (FSS)
Timepoint [1] 293109 0
Baseline and by the end of the 4 week treatment program
Primary outcome [2] 293110 0
Stress reaction tolerance, through S1 adaptive Determination Test (DT) of the computerized Vienna system.
Timepoint [2] 293110 0
Baseline and by the end of the 4 week treatment program
Secondary outcome [1] 310356 0
Disability status, through using the Expanded Disability Status Scale (EDSS)
Timepoint [1] 310356 0
Baseline and by the end of the 4 week treatment program

Eligibility
Key inclusion criteria
1- During remission state, regardless of the duration of Multiple Sclerosis (MS) established diagnosis, with less than or equal to score (6) on the EDSS scale.

2- Patients 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 (SCI), human immunosuppressive virus (HIV), hyperthyrodism, cancer or in risk of chemical or atomic radiation exposure.

3- Patients with skin type of grade 3 or 4 only.
Minimum age
20 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- Female patients who get pregnant or other patients who develop an allergic reaction to phototherapy or go into an MS relapse were excluded of the study.

2- Patients who miss more than 3 successive sessions will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be chosen from the registry of the MS outpatient clinic of the neurology department in Kasr-Aliny hospital, Cairo.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be assigned into two groups (study, and control).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Two groups, pre-post treatment design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Dependent T-test to compare pre and post treatment results in the same group. and independent T-test for comparison of pre and post treatment results between the two groups.

Person's Correlation study to test the EDSS association to the fatigue and stress reaction tolerance per and post treatment results for each group apart.

Sample size was calculated for a population of 34000 patients with MS, with 95% confidence level, 15.49 confidence interval, and 50 percentage.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/10/2014
Actual
16/10/2014
Date of last participant enrolment
Anticipated
Actual
30/11/2014
Date of last data collection
Anticipated
Actual
7/02/2015
Sample size
Target
40
Accrual to date
Final
32
Recruitment outside Australia
Country [1] 6340 0
Egypt
State/province [1] 6340 0
Cairo

Funding & Sponsors
Funding source category [1] 289915 0
Self funded/Unfunded
Name [1] 289915 0
Shimaa Essa
Country [1] 289915 0
Egypt
Primary sponsor type
Individual
Name
Shimaa Essa
Address
Faculty of physical therapy, Cairo University. Ben EL Sarayat St., Giza Square, Giza.
Postal code: 12613

Shimaa Essa: 41 Ahmed Kasem Jodah St., Nasr city, Cairo
Postal code: 11759
Country
Egypt
Secondary sponsor category [1] 288606 0
Individual
Name [1] 288606 0
Wael Shendy
Address [1] 288606 0
Faculty of physical therapy, Cairo University. Ben EL Sarayat St., Giza Square, Giza.
Postal code: 12613

Wael Shendy: 12 Abodawod Elzahery St., Nasr city, Cairo.
Postal code: 11759
Country [1] 288606 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291634 0
Faculty of physical therapy research ethical committee, Cairo University
Ethics committee address [1] 291634 0
Faculty of Physical Therapy, Cairo University, Ben El Sarayat St., Giza square, Giza.

Postal code: 12613
Ethics committee country [1] 291634 0
Egypt
Date submitted for ethics approval [1] 291634 0
23/06/2014
Approval date [1] 291634 0
24/06/2014
Ethics approval number [1] 291634 0
P.T REC/ 012/552

Summary
Brief summary
Phototherapy efficacy in ameliorating fatigue and cognitive deficits suffered by patients with MS had never been challenged before in previous applied research work. Therefore, our controlled clinical trial is the first to test the efficacy of both low level laser therapy (LLLT) and broad band ultraviolet B radiation (BB-UVBR) therapy in that domain. with clear determination of the superiority of one of the two therapies over the other.

Hypothesis:

1. Broad band Ultraviolet B radiation (BB-UVBR) will not reduce fatigue more than the low level laser therapy (LLLT).

2. Broad band Ultraviolet B radiation (BB-UVBR) will not improve reactive stress tolerance more than the low level laser therapy (LLLT) .
Trial website
Trial related presentations / publications
https://www.physiotherapyjournal.com/article/S0031-9406(15)01351-6/pdf
Public notes
Attachments [1] 177 177 0 0
/AnzctrAttachments/367053-Ethical committee approval, Shimaa Essa.pdf

Contacts
Principal investigator
Name 51270 0
Dr Shimaa Essa
Address 51270 0
Faculty of Physical therapy, Cairo University, Ben El Sarayat St., Giza Square, Giza.

Postal code: 12613
Country 51270 0
Egypt
Phone 51270 0
20 1223721631
Fax 51270 0
Email 51270 0
[email protected]
Contact person for public queries
Name 51271 0
Dr Shimaa Essa
Address 51271 0
Faculty of Physical therapy, Cairo University, Ben El Sarayat St., Giza Square, Giza.

Postal code: 12613
Country 51271 0
Egypt
Phone 51271 0
20 1223721631
Fax 51271 0
Email 51271 0
[email protected]
Contact person for scientific queries
Name 51272 0
Dr Shimaa Essa
Address 51272 0
Faculty of Physical therapy, Cairo University, Ben El Sarayat St., Giza Square, Giza.

Postal code: 12613
Country 51272 0
Egypt
Phone 51272 0
20 1223721631
Fax 51272 0
Email 51272 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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