Nucleotides and B Vitamins in the Treatment of Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640417
• Other study ID #: NHCN-03-12-15
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: October 2018

Study information

• Verified date: April 2019
• Source: Fundação Educacional Serra dos Órgãos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Nucleotides + B12
Oral treatment with either Nucleotides + Vitamin B12
• B Vitamins
Oral treatment with vitamins B1, B6, and B12

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundação Educacional Serra dos Órgãos

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event Occurrence	Percentage of subjects in each treatment group presenting with adverse events	Throughout 60 day treatment period
Secondary	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)
Secondary	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)
Secondary	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)