Vertebrogenic Radiculopathy L5, S1
Conditions
Brief summary
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
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
Interventions
Sponsors
Valeant Russia, LLC
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analoguе Scale | baseline and 3 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Pain Quality and Intensity in McGill Pain Questionnaire | baseline and 3 weeks | 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. |
| Change from Baseline in Low Back Pain Intensity in Aberdeen Back Pain Scale | baseline and 3 weeks | 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. |
| Change from Baseline in Low Back Pain Intensity in Quebec Back Pain Disability Scale | baseline and 3 weeks | 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. |
Other
| Measure | Time frame |
|---|---|
| Change from Baseline in Systolic Blood Pressure at 10 Days | baseline and 10 days |
| Change from Baseline in Urine Test at 3 weeks | baseline and 3 weeks |
| Change from Baseline in Systolic Blood Pressure at 3 weeks | baseline and 3 weeks |
| Change from Baseline in Heart Rate and Rhythm (Electrocardiogram) at 3 weeks | baseline and 3 weeks |
| Change from Baseline in Full Blood Count at 3 weeks | baseline and 3 weeks |
Countries
Russia
Outcome results
None listed