The Impact of Phototherapy on the modification of Fatigue and Cognitive functions for patients with Relapsing Remitting Multiple Sclerosis.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001025628
• Date of registration: 24/09/2014
• Prospective Registration: Yes
• Primary sponsor: Shimaa Essa
• 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.
• Date of first enrolment: 16/10/2014
• Target sample size: 40
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001025628.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Egypt

Contacts

• Name: Dr Shimaa Essa

• Name: Dr Shimaa Essa

Key inclusion & exclusion criteria

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.



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.


Age minimum: 20 Years
Age maximum: 45 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Mental Health - Studies of normal psychology, cognitive function and behaviour

Fatigue caused by Multiple sclerosis;Stress reaction tolerance (cognitive function), of patients with Multiple sclerosis;Multiple Sclerosis;
Fatigue caused by Multiple sclerosis
Stress reaction tolerance (cognitive function), of patients with Multiple sclerosis
Multiple Sclerosis

Physical Medicine / Rehabilitation - Physiotherapy

Neurological - Multiple sclerosis

Intervention(s)

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.

Primary Outcome(s)

Stress reaction tolerance, through S1 adaptive Determination Test (DT) of the computerized Vienna system.[Baseline and by the end of the 4 week treatment program]

Fatigue severity, using the Fatigue Severity Scale (FSS)[Baseline and by the end of the 4 week treatment program]

Secondary Outcome(s)

Disability status, through using the Expanded Disability Status Scale (EDSS) [Baseline and by the end of the 4 week treatment program]

Secondary ID(s)

NIL

Source(s) of Monetary Support

Shimaa Essa

Secondary Sponsor(s)

Wael Shendy

Ethics review

Status: Approved
Approval date:
Contact:

Faculty of physical therapy research ethical committee, Cairo University