Milgamma® and Milgamma® Compositum Step-therapy in Patients With Acute Non-specific Low Back Pain Receiving Modern NSAID

Woerwag Pharma LLC500 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Acute Non-specific Low Back Pain

Interventions

Exposure of interest (within routine clinical practice):Vitamin B complexes Milgamma® and Milgamma® compositumDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (21)

LLC Medical Center "Nebolit"

Mytishchi, Moscow Oblast, Russia

Outcomes

Primary Outcomes

Change of Pain Intensity After 10 Days of Treatment

Time frame: Baseline; Visit 3 (10 days after the start of treatment)

Secondary Outcomes

Change of Pain Intensity After 5, 24 and 38 Days of Treatment

Time frame: 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)

Change of Pain Intensity Over Time

Pain intensity was measured using 0-10 point Numeric Rating Scale (NRS). NRS is 11-step scale for assessment of pain intensity at the moment of patient's examination ranging from 0 (no pain) to 10 (worst pain imaginable). Pain intensity was measured at baseline, at 5, 10, 24 and 38 days after the start of treatment. A mixed model repeated measures was used to analyze change from baseline in pain intensity over time from Baseline to Visit 5 (38 days after the start of treatment) in each group. The model included a random effect for subject and fixed effect terms for treatment, visit, treatment-by-visit interaction, baseline pain intensity. An unstructured covariance structure was used to model the within-subject errors. P-value was calculated for the difference between treatment groups.

Time frame: From Baseline to Visit 5 (38 days after the start of treatment)

Percentage of Patients With 30% Low Back Pain Relief After 5, 10, 24 and 38 Days of Treatment.

Data from ClinicalTrials.gov

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LLC "Research Medical Complex "Vashe Zdorovie"

Kazan', Russia

State Healthcare Institution "Republican Clinical Neurological Center"

Kazan', Russia

Regional State Budgetary Institution of Health "Regional Clinical Hospital № 1" named after Prof. S.I. Sergeev

Khabarovsk, Russia

Federal State Healthcare Institution "Russian Scientific Center of Surgery named after academician B.V. Petrovsky"

Moscow, Russia

LLC "Medicina"

Moscow, Russia

Non-state Healthcare Institution "Central Clinical Hospital No. 2 named after N.A. Semashko of the JSC Russian Railways

Moscow, Russia

LLC "Clinical Diagnostic Center Avitsena"

Naberezhnye Chelny, Russia

LLC "Licon Plus"

Naberezhnye Chelny, Russia

LLC "Medis"

Nizhny Novgorod, Russia

...and 11 more locations

Pain intensity was measured using 0-10 point Numeric Rating Scale (NRS). NRS is 11-step scale for assessment of pain intensity at the moment of patient's examination ranging from 0 (no pain) to 10 (worst pain imaginable). Relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 2, 3, 4 or 5)/ pain intensity at baseline. Percentage of patients showing at least 30% low back pain relief at Visit 2 (5 days after the start of treatment), at Visit 3 (10 days after the start of treatment), at Visit 4 (24 days after the start of treatment) and at Visit 5 (38 days after the start of treatment) were calculated separately.

Time frame: 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)

Change in Pain-related Disability After 10 Days of Treatment

Patients' disability was assessed using Roland Morris disability questionnaire (RMDQ). RMDQ is a 24-item self-administered disability measure in which greater level of pain-related disability is reflected by higher score. The RMDQ score ranges from 0 to 24 with a lower score indicating better function.

Time frame: Baseline; Visit 3 (10 days after the start of treatment)

Percentage of Patients With at Least One Pain Flare-up During the Study

Time frame: From Visit 5 (38 days after the start of treatment) to Visit 9 (End of Study Visit, 94 days after the start of treatment)

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

Episode of pain flare-up was defined as presence of at least 1 day with low back pain following a period without pain lasting at least 4 weeks. Therefore pain flare-ups were registered no earlier than 4 weeks after the start of treatment, i.e. starting from Visit 5 (38 days after the start of treatment). The occurrence of pain flare-up was determined by the investigator. Percentages of patients with at least one pain flare-up resulting in consultancy with physician or professional management, resulting in disruption of daily activity, and resulting in NSAIDs intake were analyzed separately.

Time frame: From Visit 5 (38 days after the start of treatment) to Visit 9 (End of Study Visit, 94 days after the start of treatment)

Number of Treatment Days With NSAIDs

Number of treatment days with NSAIDs was calculated using the data collected on the NSAIDs intake during the study irrespective of the specific drug used. Duration of each intake period was determined as Stop date - Start date +1 and, finally, all individual duration values were summed up. In case medication intake was ongoing at the End of Study Visit, stop date was imputed by the date of study completion.