Low Back Pain
Conditions
Keywords
Nucleotides (uridine, cytidine), Vitamin B1, Vitamin B6, Vitamin B12
Brief 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.
Detailed description
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.
Interventions
DRUGNucleotides + B12
Oral treatment with either Nucleotides + Vitamin B12
DRUGB Vitamins
Oral treatment with vitamins B1, B6, and B12
Sponsors
Fundação Educacional Serra dos Órgãos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Occurrence | Throughout 60 day treatment period | Percentage of subjects in each treatment group presenting with adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low back pain Questionnaire | Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment) | Percentage of subjects in each treatment group presenting improvement of \>5 points in Questionnaire scores |
| Visual Analog Pain Scores | Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment) | Percentage of subjects in each treatment group presenting improvement of VAS pain scores in relation to pretreatment |
| Finger-to-Floor Distance | Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment) | Percentage of subjects in each treatment group presenting improvement of \>3cm in finger to floor distance in relation to pretreatment values |
Outcome results
None listed