N/A
N=500
Milgamma® and Milgamma® Compositum Step-therapy in Patients With Acute Non-specific Low Back Pain Receiving Modern NSAID
Acute Non-specific Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT03892707 ↗Enrolled (actual)
500
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Change of Pain Intensity After 10 Days of Treatment — -5.1; -4.0 units on a scale — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Exposure of interest (within routine clinical practice):Vitamin B complexes Milgamma® and Milgamma® compositum (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Woerwag Pharma LLC
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Pain Intensity After 10 Days of Treatment |
-5.1; -4.0 | <0.001 sig |
| SECONDARY Change of Pain Intensity After 5, 24 and 38 Days of Treatment |
-3.1; -2.4; -6.1; -5.3; -6.3; -6.0 | <0.001 sig |
| SECONDARY Change of Pain Intensity Over Time |
-5.1; -4.4 | <0.001 sig |
| SECONDARY Percentage of Patients With 30% Low Back Pain Relief After 5, 10, 24 and 38 Days of Treatment. |
194; 140; 235; 214; 241; 240 | <0.001 sig |
| SECONDARY Change in Pain-related Disability After 10 Days of Treatment |
-8.4; -7.0 | <0.001 sig |
| SECONDARY Percentage of Patients With at Least One Pain Flare-up During the Study |
35; 10 | <0.001 sig |
| 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 |
4; 4; 20; 4; 19; 8 | — |
| SECONDARY Number of Treatment Days With NSAIDs |
9.6; 10.6 | 0.986 |
| SECONDARY Prescribed and Actual Number of Milgamma® Injections |
9.3; 9.3 | — |
| SECONDARY Prescribed and Actual Number of Treatment Days With Milgamma® Compositum |
30.1; 29.9 | — |
| SECONDARY Patient Satisfaction With Treatment |
3.8; 3.8; 4.2; 4.1; 4.5; 4.5 | 0.921 |
| SECONDARY Percentage of Patients Prematurely Discontinued Milgamma®/ Milgamma® Compositum Treatment |
226; 2; 19; 2; 1 | — |
| SECONDARY Reasons for Early Discontinuation of Study Participation |
244; 244; 0; 0; 0; 1 | — |
| SECONDARY Frequency and Severity of Adverse Drug Reactions (ADRs) |
1; 5; 0; 0; 0; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03892707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.