Nucleotides and B Vitamins in the Treatment of Low Back Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Nucleotides + B12
* Drug: B Vitamins


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nucleotides + B12<br>Nucleotides + Vitamin B12 Dose: two capsules, three times per day + placebo corresponding to Group B treatment | Drug: Nucleotides + B12<br>* Oral treatment with either Nucleotides + Vitamin B12<br>* Other names: Group A;|
| Active Comparator: B vitamins<br>Vitamin B1 + Vitamin B6 + Vitamin B12 Dose: one tablet, three times daily + placebo corresponding to Group A treatment | Drug: B Vitamins<br>* Oral treatment with vitamins B1, B6, and B12<br>* Other names: Group B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event Occurrence | Percentage of subjects in each treatment group presenting with adverse events | Throughout 60 day treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back pain Questionnaire | Percentage of subjects in each treatment group presenting improvement of >5 points in Questionnaire scores | 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 | 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 | Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nucleotides (uridine, cytidine), Vitamin B1, Vitamin B6, Vitamin B12