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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nucleotides + B12 | Experimental | Nucleotides + Vitamin B12 Dose: two capsules, three times per day + placebo corresponding to Group B treatment |
|
| B vitamins | Active Comparator | Vitamin B1 + Vitamin B6 + Vitamin B12 Dose: one tablet, three times daily + placebo corresponding to Group A treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucleotides + B12 | Drug | Oral treatment with either Nucleotides + Vitamin B12 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Occurrence | Percentage of subjects in each treatment group presenting with adverse events | Throughout 60 day treatment period |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco AN Mibielli, MD | UNIFESO - Fundação Educacional Serra dos Órgãos | Principal Investigator |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D009711 | Nucleotides |
| D014805 | Vitamin B 12 |
| D014803 | Vitamin B Complex |
| ID | Term |
|---|---|
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D045728 | Corrinoids |
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| B Vitamins | Drug | Oral treatment with vitamins B1, B6, and B12 |
|
|
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) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D045725 |
| Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D014815 | Vitamins |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |