Nucleotides and B Vitamins in the Treatment of Low Back Pain

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundação Educacional Serra dos Órgãos
• Treatments: Hydroxocobalamin; Thiamine; Vitamin B 12; Vitamin B 6; Vitamin B Complex; Vitamins

Criteria

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