Milgamma® and Milgamma® Compositum Step-therapy in Patients With Acute Non-specific Low Back Pain Receiving Modern NSAID
Condition: Acute Non-specific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The purpose of this study is to assess the effectiveness and safety of add-on Milgamma®/
      Milgamma® compositum step-therapy in patients with acute non-specific low back pain receiving
      modern NSAIDs in routine medical practice.
    

Detailed description: 
      This is a multi-centre observational prospective study that was planned for assessment the
      effectiveness of neurotropic vitamins therapy with Milgamma®/ Milgamma® compositum in
      combination with modern NSAIDs (preferential/selective cyclooxygenase-2 (COX-2) inhibitors)
      in patients with acute non-specific back pain. Approximately 500 adult out-patients with
      acute non-specific low back pain who have been prescribed therapy consisting of (1) modern
      NSAIDs (preferential/selective COX-2 inhibitors) or (2) modern NSAIDs (preferential/selective
      COX-2 inhibitors) + Milgamma® / Milgamma® compositum will be enrolled in the study. Each
      patient will be observed over a period of approximately 94 days. 9 visits/phone contacts are
      planned to be conducted during this period. Information about patient's condition, pain
      intensity, pain flare-ups, satisfaction with the treatment, patient's disability, therapy
      used for acute back pain treatment, data on safety will be collected during these contacts.
      Pain intensity will be measured with Numeric Rating Scale (NRS), patients' disability will be
      evaluated with Roland Morris disability questionnaire, patients' satisfaction with the
      treatment will be assessed with 5-point verbal rating scale. Safety assessment will be based
      on frequency and severity of adverse drug reactions recorded during the study.

      Prior to the start of the study, neurologists (potential investigators) will be asked to fill
      out feasibility questionnaires to identify their individual routine practice regarding
      prescription or non-prescription of Milgamma® / Milgamma® compositum. Based on results of
      feasibility physicians will be divided to non-prescribers and prescribers of Milgamma® /
      Milgamma® compositum to the patients with acute non-specific low back pain. In each medical
      institution, such non-prescribers and prescribers will be proposed to participate in the
      study. Non-prescribers will be responsible for enrolling group (1) (NSAIDs alone),
      prescribers will be responsible for enrolling group (2) (NSAIDs + Milgamma® / Milgamma®
      compositum).
    

Intervention name(s): Exposure of interest (within routine clinical practice):Vitamin B complexes Milgamma® and Milgamma® compositum
Intervention type(s): Drug
Intervention description(s): Milgamma®: 2 mL injection solution containing thiamin hydrochloride 100 mg, pyridoxine hydrochloride 100 mg, cyanocobalamin 1 mg, lidocaine hydrochloride 20 mg.
Milgamma® compositum: 1 tablet containing benfotiamine 100 mg, pyridoxine hydrochloride 100 mg.
Other intervention name(s): Non-Steroidal Anti-Inflammatory Drugs (celecoxib, etoricoxib, meloxicam, nimesulide)
Intervention MeSH terms: Folic Acid; Vitamin B Complex; Celecoxib; Etoricoxib; Meloxicam; Anti-Inflammatory Agents, Non-Steroidal; Nimesulide; Anti-Inflammatory Agents; Benphothiamine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult out-patients will be enrolled by neurologists in clinical sites all over the Russian
        Federation.
      
Keywords: Low back pain; Milgamma; NSAIDs