Comparing Metamizole and Ibuprofen for Acute Low Back Pain Treatment
Efficacy of Metamizole Versus Ibuprofen and a Short Educational Intervention Versus Standard Care in Acute and Subacute Low Back Pain: A Randomized, Factorial Trial
This study is testing whether metamizole works just as well as ibuprofen for treating acute low back pain, while also seeing if a short educational session helps patients feel better compared to regular care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT04111315 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of metamizole, a non-opioid pain medication, compared to ibuprofen in treating acute low back pain. It employs a randomized, double-blind, controlled design to assess whether metamizole is non-inferior to ibuprofen. Additionally, the study investigates the impact of a short educational intervention on patient outcomes compared to standard care. The goal is to provide effective pain management while minimizing the risks associated with opioid use and NSAIDs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older experiencing new onset low back pain lasting less than 12 weeks.
Not a fit: Patients with serious underlying conditions or contraindications to the study medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and effective alternative for managing acute low back pain without the risks associated with opioids.
How similar studies have performed: While the use of metamizole has increased, its efficacy for low back pain has not been systematically studied, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent as documented by signature * Age 18 years or older * Seeking care for new onset of non-specific or specific LBP (pain duration of less than 12 weeks LBP prior to the baseline visit) * The GP plans to prescribe a non-opioid pain medication for pain control Exclusion Criteria: * Presence of red flags (serious neurological deficit requiring surgery, infection, vertebral fracture) * Active malignancy and / or history of a (previous) hematologic disorder (anemia (hemoglobin \< 10.0 g/L), neutropenia or agranulocytosis, thrombocytopenia), * Known contraindications against the study medications: heart failure (NYHA III-IV), liver failure (liver cirrhosis, ascites), renal insufficiency (estimated glomerular filtration rate (eGFR) \< 60 ml/min/1,73 m2) or previous acute kidney injury (AKI stage 2 according to the KDIGO definition), previous gastrointestinal ulcer, inflammatory bowel disease. * Immune deficiency or under immunosuppressant treatment * Current use of opioids * Known intolerance to the study medication (i.e. previous acute allergic reaction to the study medication) * Patients unable or unwilling to follow instructions or do not speak and are unable to read / understand German * Patients unable to provide informed consent themselves * Known or suspected non-compliance, drug or alcohol abuse * Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia, etc. * Participation in another study within the 30 days preceding the randomization and during the present study or previous enrolment into the current study * Enrolment of the investigator, his/her family members, employees and other dependent persons * Pregnancy: In women in the child bearing age a negative pregnancy test (urine or blood test as available in the primary care practice) before inclusion is required. Women who are not willing to use safe contraception (condom or birth control pill) during the course of the trial, intention to become pregnant during the trial, pregnancy, or breast feeding
Where this trial is running
Bern
- University Hospital Bern — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Maria M. Wertli, MD PhD — University of Bern
- Study coordinator: Maria M. Wertli, MD PhD
- Email: Maria.Wertli@insel.ch
- Phone: +41796576420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.