Nucleotides and B Vitamins in the Treatment of Low Back Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: Nucleotides + B12; Drug: B Vitamins

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Fundação Educacional Serra dos Órgãos
• Investigators: Principal Investigator: Marco AN Mibielli, MD, UNIFESO - Fundação Educacional Serra dos Órgãos

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Vitamin B12; Vitamin B1; Vitamin B6; Nucleotides (uridine, cytidine)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex
• Other Study ID Numbers: NHCN-03-12-15