| Primary | Change of Pain Intensity After 10 Days of Treatment | 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 and at 10 days after the start of treatment. | | Posted | | Mean | Standard Deviation | units on a scale | | Baseline; Visit 3 (10 days after the start of treatment) | | | | ID | Title | Description |
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| OG000 | NSAIDs Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) | | OG001 | NSAIDs+Milgamma+Milgamma Compositum Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-5.1± 1.8
- OG001-4.0± 1.7
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Since the superiority of one treatment over the other is investigated and taking into consideration that smaller negative values of the primary variable correspond to the greater reduction of pain, the statistical hypotheses are: Null hypothesis (H0): H0: μ2 - μ1 ≥ 0 Alternative hypothesis (HA): HA: μ2 - μ1 < 0, where μ1 и μ2 are the mean changes from baseline in pain intensity for (1) modern NSAIDs therapy and for (2) modern NSAIDs + Milgamma\ Milgamma compositum therapy, correspondingly. | ANCOVA | | <0.001 | | | | | | | | | | | | | | Superiority | The between-group comparison on primary endpoint - change from baseline in pain intensity as measured on 0-10 points NRS scale at 10 days after the start of treatment was performed using analysis of covariance (ANCOVA). The difference between pain intensity at 10 days after the start of treatment and baseline (V3-V1) as response variable, treatment group as fixed factor and baseline pain intensity as a covariate was included into the model. |
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| Secondary | Change of Pain Intensity After 5, 24 and 38 Days of Treatment | 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, 24 and 38 days after the start of treatment.Changes of pain intensity from baseline to Day 5, from baseline to Day 24 and from baseline to Day 38 after the start of treatment were calculated separately. | | Posted | | Mean | Standard Deviation | units on a scale | | 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) | | | | ID | Title | Description |
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| OG000 | NSAIDs Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) | | OG001 | NSAIDs+Milgamma+Milgamma Compositum Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum 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. |
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| Secondary | 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. | | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | From Baseline to Visit 5 (38 days after the start of treatment) | | | | ID | Title | Description |
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| OG000 | NSAIDs Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) | | OG001 | NSAIDs+Milgamma+Milgamma Compositum Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum 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. |
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| Secondary | Percentage of Patients With 30% Low Back Pain Relief After 5, 10, 24 and 38 Days of Treatment. | 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. | | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | NSAIDs Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) | | OG001 | NSAIDs+Milgamma+Milgamma Compositum Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum 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. |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | units on a scale | | Baseline; Visit 3 (10 days after the start of treatment) | | | | ID | Title | Description |
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| OG000 | NSAIDs Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) | | OG001 | NSAIDs+Milgamma+Milgamma Compositum Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum 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. |
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| Secondary | Percentage of Patients With at Least One Pain Flare-up During the Study | 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. | Full Analysis Set (FAS). Denominator of proportion was the number of FAS patients who had at least one pain-free period during the study. | Posted | | Count of Participants | | Participants | | From Visit 5 (38 days after the start of treatment) to Visit 9 (End of Study Visit, 94 days after the start of treatment) | | | | ID | Title | Description |
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| OG000 | NSAIDs Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) | | OG001 | NSAIDs+Milgamma+Milgamma Compositum Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum 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. |
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| Secondary | 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. | Full Analysis Set (FAS). Denominator of proportion is the number of FAS patients who had at least one pain-free period and at least one pain flare-up episode during the study | Posted | | Count of Participants | | Participants | | From Visit 5 (38 days after the start of treatment) to Visit 9 (End of Study Visit, 94 days after the start of treatment) | | | | ID | Title | Description |
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| OG000 | NSAIDs Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) | | OG001 | NSAIDs+Milgamma+Milgamma Compositum Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum 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. |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | Days of treatment | | From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit | | | | ID | Title | Description |
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| OG000 | NSAIDs Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) | | OG001 | NSAIDs+Milgamma+Milgamma Compositum Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum 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. |
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| Secondary | Prescribed and Actual Number of Milgamma® Injections | Prescribed number of Milgamma® injections was reported at Baseline visit. Actual number of injections was calculated by counting the number of injections administered and reported starting from Visit 2. If the treatment was interrupted, the days patient did not receive Milgamma® injections were not contribute to the total number of injections. | | Posted | | Mean | Standard Deviation | number of injections | | From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit | | | | ID | Title | Description |
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| OG000 | NSAIDs+Milgamma+Milgamma Compositum Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum |
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| Secondary | Prescribed and Actual Number of Treatment Days With Milgamma® Compositum | Prescribed number of treatment days with Milgamma® compositum intake was reported at Baseline visit. Actual number of treatment days was calculated by summing up all the individual periods of treatment with Milgamma® compositum (in days) reported starting from Visit 2. If the treatment was interrupted, the days patient did not receive Milgamma® compositum were not contribute to the total number of treatment days with Milgamma® compositum intake. | | Posted | | Mean | Standard Deviation | Days of treatment | | From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit | | | | ID | Title | Description |
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| OG000 | NSAIDs+Milgamma+Milgamma Compositum Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum |
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| Secondary | Patient Satisfaction With Treatment | Patient satisfaction with treatment was evaluated using a 5-point verbal rating scale (1= very dissatisfied, 2= dissatisfied, 3= neutral, 4= satisfied, 5= very satisfied) after 5, 10, 38 days and 3 months (94 days) since the start of treatment. | | Posted | | Mean | Standard Deviation | units on a scale | | 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) | | | | ID | Title | Description |
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| OG000 | NSAIDs Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) | | OG001 | NSAIDs+Milgamma+Milgamma Compositum Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum 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. |
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| Secondary | Percentage of Patients Prematurely Discontinued Milgamma®/ Milgamma® Compositum Treatment | Percentage of patients prematurely discontinued prescribed treatment with Milgamma®/ Milgamma® compositum was evaluated by reasons for discontinuation. | | Posted | | Count of Participants | | Participants | | From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit | | | | ID | Title | Description |
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| OG000 | NSAIDs+Milgamma+Milgamma Compositum Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum |
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| Secondary | Reasons for Early Discontinuation of Study Participation | Percentage of patient prematurely discontinued study participation by the following reasons: patient lost to follow-up, patient withdrew consent, administrative reasons, pain resolution, adverse event, death, other reason. | | Posted | | Count of Participants | | Participants | | From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit | | | | ID | Title | Description |
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| OG000 | NSAIDs Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) | | OG001 | NSAIDs+Milgamma+Milgamma Compositum Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum 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. |
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| Secondary | Frequency and Severity of Adverse Drug Reactions (ADRs) | As this was a non-interventional study in which NSAIDs and Milgamma® / Milgamma® compositum were administered and managed within routine medical care, safety assessment was based on frequency and severity of Adverse Drug Reactions (ADRs) recorded during the study. ADR was defined as an adverse event (AE) suspected to be causally related to the medicinal product (Milgamma®, Milgamma® compositum or NSAID). The severity grade (mild, moderate or severe) of ADR was determined based on the investigator's judgement. Adverse events not related to the medicinal product were not monitored in this observational study. | Safety population was defined as all patients who signed informed consent for entry into the study and started the study treatment. | Posted | | Count of Participants | | Participants | | From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit | | | | ID | Title | Description |
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| OG000 | NSAIDs Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) | | OG001 | NSAIDs+Milgamma+Milgamma Compositum Group | Patients with acute non-specific low back pain prescribed with modern NSAIDs (preferential/selective COX-2 inhibitors) + Milgamma® / Milgamma® compositum 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. |
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