Back to resultsNucleotides and B Vitamins in the Treatment of Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Nucleotides + B12
B Vitamins
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Nucleotides (uridine, cytidine), Vitamin B1, Vitamin B6, Vitamin B12
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nucleotides + B12
B vitamins
Arm Description
Nucleotides + Vitamin B12 Dose: two capsules, three times per day + placebo corresponding to Group B treatment
Vitamin B1 + Vitamin B6 + Vitamin B12 Dose: one tablet, three times daily + placebo corresponding to Group A treatment
Outcomes
Primary Outcome Measures
Adverse Event Occurrence
Percentage of subjects in each treatment group presenting with adverse events
Secondary Outcome Measures
Low back pain Questionnaire
Percentage of subjects in each treatment group presenting improvement of >5 points in Questionnaire scores
Visual Analog Pain Scores
Percentage of subjects in each treatment group presenting improvement of VAS pain scores in relation to pretreatment
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
Full Information
NCT ID
NCT02640417
First Posted
December 15, 2015
Last Updated
April 18, 2019
Sponsor
Fundação Educacional Serra dos Órgãos
1. Study Identification
Unique Protocol Identification Number
NCT02640417
Brief Title
Nucleotides and B Vitamins in the Treatment of Low Back Pain
Official Title
Avaliação clínica-terapêutica Comparativa em Lombalgias de Etiologia Traumato-compressivas Utilizando-se Vitaminas do Complexo B e nucleotídeos
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundação Educacional Serra dos Órgãos
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Nucleotides (uridine, cytidine), Vitamin B1, Vitamin B6, Vitamin B12
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nucleotides + B12
Arm Type
Experimental
Arm Description
Nucleotides + Vitamin B12 Dose: two capsules, three times per day + placebo corresponding to Group B treatment
Arm Title
B vitamins
Arm Type
Active Comparator
Arm Description
Vitamin B1 + Vitamin B6 + Vitamin B12 Dose: one tablet, three times daily + placebo corresponding to Group A treatment
Intervention Type
Drug
Intervention Name(s)
Nucleotides + B12
Other Intervention Name(s)
Group A
Intervention Description
Oral treatment with either Nucleotides + Vitamin B12
Intervention Type
Drug
Intervention Name(s)
B Vitamins
Other Intervention Name(s)
Group B
Intervention Description
Oral treatment with vitamins B1, B6, and B12
Primary Outcome Measure Information:
Title
Adverse Event Occurrence
Description
Percentage of subjects in each treatment group presenting with adverse events
Time Frame
Throughout 60 day treatment period
Secondary Outcome Measure Information:
Title
Low back pain Questionnaire
Description
Percentage of subjects in each treatment group presenting improvement of >5 points in Questionnaire scores
Time Frame
Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
Title
Visual Analog Pain Scores
Description
Percentage of subjects in each treatment group presenting improvement of VAS pain scores in relation to pretreatment
Time Frame
Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
Title
Finger-to-Floor Distance
Description
Percentage of subjects in each treatment group presenting improvement of >3cm in finger to floor distance in relation to pretreatment values
Time Frame
Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco AN Mibielli, MD
Organizational Affiliation
UNIFESO - Fundação Educacional Serra dos Órgãos
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Nucleotides and B Vitamins in the Treatment of Low Back Pain
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