Efficacy of combined use of Low Intensity Laser Therapy and Ultraviolet Radiation in the treatment of Relapsing-Remitting Multiple Sclerosis patients

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001186842

Enrollment

Registered

2012-11-12

Start date

2012-11-20

Completion date

Unknown

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

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).

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

25 Years to 45 Years

Healthy volunteers

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.

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.

Outcome results