Nucleotides and B Vitamins in the Treatment of Low Back Pain
April 18, 2019 updated by: Marco Antonio Naslausky Mibielli, Fundação Educacional Serra dos Órgãos
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
Intervention / Treatment
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
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
|
Oral treatment with either Nucleotides + Vitamin B12
Other Names:
|
|
Active Comparator: B vitamins
Vitamin B1 + Vitamin B6 + Vitamin B12 Dose: one tablet, three times daily + placebo corresponding to Group A treatment
|
Oral treatment with vitamins B1, B6, and B12
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Event Occurrence
Time Frame: Throughout 60 day treatment period
|
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
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
|
Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
|
|
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
|
Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
|
|
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
|
Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marco AN Mibielli, MD, UNIFESO - Fundação Educacional Serra dos Órgãos
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHCN-03-12-15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.