Multiple Sclerosis Clinical Trial
Official title:
Effect of Photobiomodulation Treatment in the Sublingual Region and Along the Spinal Column in Individuals With Multiple Sclerosis: Protocol for a Randomized, Controlled, Double-blind, Clinical Trial
Background: Multiple sclerosis (MS) is an autoimmune disease, for which the forms of
treatment are medication and rehabilitation. However, in vitro and in vivo studies have
demonstrated that photobiomodulation can be an effective treatment modality for inflammatory
diseases, including MS. Photobiomodulation has a broad range of benefits, such as the
avoidance of cell and tissue death, the stimulation of healing and injury repair, reductions
in pain, edema and inflammation, cell proliferation and even apoptosis. The outcomes of
photobiomodulation include the regeneration of cells, the stimulation of the growth of
Schwann cells, a reduction in spasticity, functional improvements, a reduction in nitric
oxide levels and the upregulation of the cytokine IL10, demonstrating that this therapeutic
modality can offer neuro-protection.
Methods: A randomized, controlled, double-blind, clinical trial is proposed. The patients
will be divided into six groups. Groups 1 and 2 will receive sham and active
photobiomodulation in the sublingual region, respectively. Groups 3 and 4 will receive sham
and active photobiomodulation along the spinal cord, respectively. Group 5 will receive
placebo treatment with photobiomodulation on the skin in the region of the radial artery with
a specific bracelet. Group 6 will be treated with photobiomodulation on the skin in the
region of the radial artery with a specific bracelet.
Discussion: Treatment for MS is directed at the immune response and slowing the progression
of the disease. This is one of the first clinical trials with sublingual and along the spinal
cord photobiomodulation, which could help establish a new, promising treatment of the disease
associated with pharmacological treatment.
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