This is a double-blind, randomized study in parallel groups of subjects presenting with low back pain. Randomized subjects will receive treatment for 60 days with either a combination of nucleotides and vitamin B12 or vitamin B1+B6+B12.
This is a double-blind, randomized study in parallel groups of subjects presenting with low back pain. Randomized subjects will receive treatment for 60 days with either a combination of nucleotides and vitamin B12 or vitamin B1+B6+B12. The aim of this study is to evaluate and compare the therapeutic effect of the combination of nucleotides + vitamin B12 with that of the combination of vitamins B1, B6 and B12 in low back pain. Safety and efficacy will be monitored throughout the treatment period. Subjects will be randomized in a double-blind fashion to either treatment group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Oral treatment with either Nucleotides + Vitamin B12
Oral treatment with vitamins B1, B6, and B12
Adverse Event Occurrence
Percentage of subjects in each treatment group presenting with adverse events
Time frame: Throughout 60 day treatment period
Low back pain Questionnaire
Percentage of subjects in each treatment group presenting improvement of \>5 points in Questionnaire scores
Time frame: Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
Visual Analog Pain Scores
Percentage of subjects in each treatment group presenting improvement of VAS pain scores in relation to pretreatment
Time frame: Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
Finger-to-Floor Distance
Percentage of subjects in each treatment group presenting improvement of \>3cm in finger to floor distance in relation to pretreatment values
Time frame: Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
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