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

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.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001025628

Enrollment

Registered

2014-09-24

Start date

2014-10-16

Completion date

2014-11-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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) .

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

20 Years to 45 Years

Healthy volunteers

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.

Outcome results