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NCT Number: NCT02640417

Nucleotides and B Vitamins in the Treatment of Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nucleotides + B12

Drug

Oral treatment with either Nucleotides + Vitamin B12

Other names: Group A

B Vitamins

Drug

Oral treatment with vitamins B1, B6, and B12

Other names: Group B

Primary outcomes

  1. Adverse Event Occurrence

    Time frame: Throughout 60 day treatment period

    Percentage of subjects in each treatment group presenting with adverse events

Secondary outcomes

  1. Low back pain Questionnaire

    Time frame: 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

  2. Visual Analog Pain Scores

    Time frame: 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

  3. Finger-to-Floor Distance

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fundação Educacional Serra dos Órgãos

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2015
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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