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Completed

NCT Number: NCT02508805

Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy

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.

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Key information

Conditions

Vertebrogenic Radiculopathy L5, S1

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

State Autonomous Institution Republican Clinical Centre of Neurology

Kazan', Tatarstan Republic, 420021, Russia

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Neuromultivit

Drug

Voltaren

Drug

Sirdalud

Drug

Primary outcomes

  1. Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analoguе Scale

    Time frame: 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 outcomes

  1. Change from Baseline in Pain Quality and Intensity in McGill Pain Questionnaire

    Time frame: 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.

  2. Change from Baseline in Low Back Pain Intensity in Aberdeen Back Pain Scale

    Time frame: 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.

  3. Change from Baseline in Low Back Pain Intensity in Quebec Back Pain Disability Scale

    Time frame: 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 outcomes

  1. Change from Baseline in Systolic Blood Pressure at 10 Days

    Time frame: baseline and 10 days

  2. Change from Baseline in Systolic Blood Pressure at 3 weeks

    Time frame: baseline and 3 weeks

  3. Change from Baseline in Heart Rate and Rhythm (Electrocardiogram) at 3 weeks

    Time frame: baseline and 3 weeks

  4. Change from Baseline in Full Blood Count at 3 weeks

    Time frame: baseline and 3 weeks

  5. Change from Baseline in Urine Test at 3 weeks

    Time frame: baseline and 3 weeks

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Collaborators

  • Valeant Russia, LLC

Registry information

Official study title

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

Acronym: NMRUS

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 27, 2015
Registry last updated
May 9, 2017

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.