Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy

Study Overview
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Brief Summary
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The purpose of the study is to assess the efficacy and safety of Neuromultivit (solution for injections) in treatment of vertebrogenic radiculopathy L5, S1 in comparison with standard therapy. The patients are randomised into two groups: standard therapy group and standard therapy plus Neuromultivit group.

Detailed Description
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Group 1 (50 patients) receive Neuromultivit (2 ml per day, i.m.) for 7 days, then -Neuromultivit (2 ml per day, i.m.) every other day for 10 days and standard therapy for 20 days. Group 2 (50 patients) receive only standard therapy for 20 days. Standard therapy involves: Voltaren (100 mg prolonged-released film-coated tablets once daily) for 20 days Sirdalud (2 mg tablets three times a day) for 20 days

Official Title
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Open Randomised Comparative Study of the Efficacy and Safety of Neuromultivit (Solution for Injections, 2 ml) in Patients With Vertebrogenic Radiculopathy

Conditions
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Vertebrogenic Radiculopathy L5, S1

Intervention / Treatment
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* Drug: Neuromultivit
* Drug: Voltaren
* Drug: Sirdalud


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed vertebrogenic radiculopathy L5, S1 radicular pain syndrome changes in the low back CT and MRI scans minimum 40 mm intensity of spontaneous back pain, rated on the VA scale 1 month exacerbation phase; nonuse of any B-group vitamins before the trial negative urine pregnancy test; Patient Informed Consent Exclusion Criteria: tumors, inflammatory infections, any neurological diseases, imitating the symptoms of radiculopathy concomitant life-threatening medical conditions simultaneous administration of acetylsalicylic acid, levodopa, prednisolone; any psychiatric diseases epilepsy, alcohol and drug addiction pregnancy and breast-feeding any condition preventing CT and MRI tests, including obesity and special devices participation in any other clinical study 1 month before enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuromultivit +Voltaren+Sirdalud<br>Neuromultivit 2ml i.m. once a day for 7 days, then 2 ml i.m. one time every other day for 10 days. Voltaren 100mg per os once a day for 20 days. Sirdalud 2 mg per os three times a day for 20 days. | Drug: Neuromultivit<br> <br> Drug: Voltaren<br> <br> Drug: Sirdalud<br> <br> |
| Active Comparator: Voltaren+Sirdalud alone<br>Voltaren 100mg per os once a day for 20 days Sirdalud 2 mg per os three times a day for 20 days | Drug: Voltaren<br> <br> Drug: Sirdalud<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analoguе Scale | Self reported pain intensity over the last 24 hours. The amount of pain is marked on a horizontal line at a certain point which reflects pain perception best: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). | baseline and 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Pain Quality and Intensity in McGill Pain Questionnaire | Self reported quality and intensity of pain, described by selecting 7 words, which reflect pain perception best, from 20 groups: three words from groups 1-10, two words from groups 11-15, a single word from group 16, one word from groups 17-20. | baseline and 3 weeks | 
| Change from Baseline in Low Back Pain Intensity in Aberdeen Back Pain Scale | Self reported effect of pain on body functions and daily activities. The scores of responses to 19 questions (6 multiple choice questions and 13 single choice questions) are summed, yielding a total between 0 and 100 with higher values representing greater disability. | baseline and 3 weeks | 
| Change from Baseline in Low Back Pain Intensity in Quebec Back Pain Disability Scale | Self reported pain related functional limitations to 20 activities. The degree of difficulty in performing these daily activities is scored from 0-5 (0 = no effort, 5 = not able to), yielding a total between 0 and 100 with higher values representing greater disability. | baseline and 3 weeks |