Nucleotides and B Vitamins in the Treatment of Low Back Pain

Avaliação clínica-terapêutica Comparativa em Lombalgias de Etiologia Traumato-compressivas Utilizando-se Vitaminas do Complexo B e nucleotídeos

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.

Inclusion Criteria:

• Patients of both genders, at least 18 years of age
• Clinical presentation of acute lumbago (<3 days of initial visit, with and without functional alteration, with medium intensity: Visual Analog Pain score between 20mm and 80mm
• Female subjects should be post-menopausal or using birth control
• Subjects must sign informed consent document

Exclusion Criteria:

• Intolerance to any component of the study treatments
• Pregnancy or breastfeeding
• Need for surgical treatment
• Use of other analgesic drugs
• dyshematopoiesis or coagulation disorder
• Gastric or intestinal ulcer
• Gastrointestinal, cerebrovascular, or other bleeding
• Creatinine >3x% reference range
• Urea, ALT, AST, or GGT >2x% reference range
• Any other disease or condition that in the investigator's opinion should exclude the subject from the study