Clinical trial NCT03892707: Milgamma® and Milgamma® Compositum Step-therapy in Patients With Acute Non-specific Low Back Pain Receiving Modern NSAID
Official title: Observational Study of Effectiveness and Safety of Add-on Milgamma® and Milgamma® Compositum Step-Therapy in Routine Practice of Management of Adult Patients With Acute Non-Specific Low Back Pain Receiving Modern NSAIDs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Non-specific Low Back Pain
Keywords: Low back pain
Milgamma
NSAIDs
Lead sponsor: Woerwag Pharma LLC
Sponsor class: INDUSTRY
First posted: 2019-03-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
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.

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Signed informed consent including data protection declaration according to the local legislation.
* Acute non-specific low back pain less than 21 days (= 3 weeks).
* Low back pain treatment with (1) modern NSAIDs (preferential/selective COX-2 inhibitors) or (2) modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma®/ Milgamma® compositum prescribed (but not started yet) in frames of routine medical practice.
* Prescribed (but not started yet) step-therapy with Milgamma® to be followed by Milgamma® compositum in accordance with locally approved instruction for medical use (for the group planned to be treated with Milgamma®/ Milgamma® compositum step-therapy).
* Pain intensity according to Numerical Rating Scale (NRS) ≥4 points ≤9 at the time of enrollment.
* In case of presence of previous episodes of acute non-specific low back pain in medical history, the last one had resolved at least 30 days before the start of current episode.

Exclusion Criteria:

* History or presence of any disease that, in the opinion of the investigator, might confound the results of the study, poses an additional risk to the subject during participation in the study or can change pain perception (examples of such possible conditions: any malignancy, stomach ulcer, duodenal ulcer, chronic heart failure, bronchial asthma, psychiatry disorders, epilepsy, Parkinson Disease etc).
* Spinal surgery/rehabilitation in the last 12 months.
* Acute back pain that is attributable to any known or suspected specific identifiable cause (e.g. discogenic radiculopathy, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumor).
* Severe scoliosis.
* Use of NSAIDs or vitamins B within 2 months prior to enrollment into the study.
* Necessity to use myorelaxants or antidepressants for treatment of acute non-specific low back pain.
* Prior use of non-pharmacological treatment (physiotherapy, heat treatment (e.g. heat patch, hot water bottle) or topically applied medicinal products to the back area, procaine blocks) within the last 3 days before study entry.

Primary outcomes:
measure: Change of Pain Intensity After 10 Days of Treatment
timeFrame: Baseline; Visit 3 (10 days after the start of treatment)
Secondary outcomes:
measure: Change of Pain Intensity After 5, 24 and 38 Days of Treatment
timeFrame: Baseline; Visit 2 (5 days after the start of treatment), Visit 4 (24 days after the start of treatment); Visit 5 (38 days after the start of treatment)
measure: Change of Pain Intensity Over Time
timeFrame: From Baseline to Visit 5 (38 days after the start of treatment)
measure: Percentage of Patients With 30% Low Back Pain Relief After 5, 10, 24 and 38 Days of Treatment.
timeFrame: Visit 2 (5 days after the start of treatment); Visit 3 (10 days after the start of treatment); Visit 4 (24 days after the start of treatment) and Visit 5 (38 days after the start of treatment)
measure: Change in Pain-related Disability After 10 Days of Treatment
timeFrame: Baseline; Visit 3 (10 days after the start of treatment)
measure: Percentage of Patients With at Least One Pain Flare-up During the Study
timeFrame: From Visit 5 (38 days after the start of treatment) to Visit 9 (End of Study Visit, 94 days after the start of treatment)
measure: Percentage of Patients With at Least One Pain Flare-up Resulting in Consultancy With Physician, Resulting in Disruption of Daily Activity, and Resulting in NSAIDs Intake
timeFrame: From Visit 5 (38 days after the start of treatment) to Visit 9 (End of Study Visit, 94 days after the start of treatment)
measure: Number of Treatment Days With NSAIDs
timeFrame: From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit
measure: Prescribed and Actual Number of Milgamma® Injections
timeFrame: From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit
measure: Prescribed and Actual Number of Treatment Days With Milgamma® Compositum
timeFrame: From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit
measure: Patient Satisfaction With Treatment
timeFrame: Visit 2 (5 days after the start of treatment); Visit 3 (10 days after the start of treatment); Visit 5 (38 days after the start of treatment) and Visit 9 (94 days after the start of treatment)
measure: Percentage of Patients Prematurely Discontinued Milgamma®/ Milgamma® Compositum Treatment
timeFrame: From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit
measure: Reasons for Early Discontinuation of Study Participation
timeFrame: From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit
measure: Frequency and Severity of Adverse Drug Reactions (ADRs)
timeFrame: From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit
Other outcomes:
Locations:
city: Mytishchi
country: Russian Federation
facility: LLC Medical Center "Nebolit"
state: Moscow Region
city: Ekaterinburg
country: Russian Federation
facility: LLC "Center for Medical Prevention and Rehabilitation treatment "Kamkor"
city: Kazan
country: Russian Federation
facility: LLC "Research Medical Complex "Vashe Zdorovie"
city: Kazan
country: Russian Federation
facility: State Healthcare Institution "Republican Clinical Neurological Center"
city: Khabarovsk
country: Russian Federation
facility: Regional State Budgetary Institution of Health "Regional Clinical Hospital № 1" named after Prof. S.I. Sergeev
city: Moscow
country: Russian Federation
facility: Federal State Healthcare Institution "Russian Scientific Center of Surgery named after academician B.V. Petrovsky"
city: Moscow
country: Russian Federation
facility: LLC "Medicina"
city: Moscow
country: Russian Federation
facility: Non-state Healthcare Institution "Central Clinical Hospital No. 2 named after N.A. Semashko of the JSC Russian Railways
city: Naberezhnye Chelny
country: Russian Federation
facility: LLC "Clinical Diagnostic Center Avitsena"
city: Naberezhnye Chelny
country: Russian Federation
facility: LLC "Licon Plus"
city: Nizhny Novgorod
country: Russian Federation
facility: LLC "Medis"
city: Novosibirsk
country: Russian Federation
facility: JSC "MEdical Center Avitsenna", group of companies "Mother and Child"
city: Novosibirsk
country: Russian Federation
facility: LLC "MRI-Expert Novosibirsk"
city: Omsk
country: Russian Federation
facility: LLC "Multidisciplinary center of modern medicine "Euromed"
city: Saint Petersburg
country: Russian Federation
facility: Federal State Healthcare Institution St. Petersburg Clinical Hospital of the Russian Academy of Sciences
city: Saint Petersburg
country: Russian Federation
facility: Out-patient clinic of SUE St. Petersburg Metropoliten
city: Ufa
country: Russian Federation
facility: LLC "MD Project 2010"
city: Ufa
country: Russian Federation
facility: LLC "National Medical Holding Medstandart"
city: Volgograd
country: Russian Federation
facility: Volgograd State Medical University
city: Yaroslavl
country: Russian Federation
facility: LLC "Center of Evidence-Based Medicine"
city: Yaroslavl
country: Russian Federation
facility: State Healthcare Institution of Yaroslavl Region "Clinical Hospital №8"
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University
name: Vladimir Parfenov
role: STUDY_CHAIR
References: