Nucleotides and B Vitamins in the Treatment of Low Back Pain

Phase 4

Completed

• Conditions: Low Back Pain
• Interventions: Drug: Nucleotides + B12; Drug: B Vitamins

• Registration Number: NCT02640417
• Lead Sponsor: Fundação Educacional Serra dos Órgãos

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.

Study Timeline

• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-29
• Study Start: 2016-03
• Primary Completion: 2018-03
• Study Completion: 2018-10
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-18
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nucleotides + B12	Nucleotides + B12	Nucleotides + Vitamin B12 Dose: two capsules, three times per day + placebo corresponding to Group B treatment
B vitamins	B Vitamins	Vitamin B1 + Vitamin B6 + Vitamin B12 Dose: one tablet, three times daily + placebo corresponding to Group A treatment

Primary Outcome Measures

Name	Time	Method
Adverse Event Occurrence	Throughout 60 day treatment period	Percentage of subjects in each treatment group presenting with adverse events

Secondary Outcome Measures

Name	Time	Method
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
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
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