Efficacy of Metamizole Versus Ibuprofen and a Short Educational Intervention Versus Standard Care in Acute Low Back Pain (EMISI)
Low Back Pain
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Pain medications, Non-opioid pain medications, Educational intervention
Eligibility 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
Sites / Locations
- University Hospital BernRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
metamizole + educational intervention
metamizole + standard care
ibuprofen + educational intervention
ibuprofen + standard care
(A) Metamizole (Novalgin® Oblong tablets 0,5 g) orally three times daily 2 capsules for 4 days followed by an as needed regimen (days 4 - 42). The treatment duration will depend on the duration of pain. Patients are considered to be recovered when their pain is below 2 (NRS 0-10) on 2 consecutive days after they stopped the pain medication (end of treatment). (B) Educational short intervention: patients receive two leaflets with information non-specific LBP and exercises to alleviate LBP. Further, patients receive a 10-minute standardized telephone intervention during the first 4 treatment days.
(A) Metamizole (Novalgin® Oblong tablets 0,5 g) orally three times daily 2 capsules for 4 days followed by an as needed regimen (days 4 - 42). The treatment duration will depend on the duration of pain. Patients are considered to be recovered when their pain is below 2 (NRS 0-10) on 2 consecutive days after they stopped the pain medication (end of treatment). (B) Standard care will be prescribed by the GP.
(A) Ibuprofen (Ibufen-L® tablets 500 mg) orally three times daily 2 capsules for 4 days followed by an as needed regimen (days 4 - 42). The treatment duration will depend on the duration of pain. Patients are considered to be recovered when their pain is below 2 (NRS 0-10) on 2 consecutive days after they stopped the pain medication (end of treatment). (B) Educational short intervention: patients receive two leaflets with information non-specific LBP and exercises to alleviate LBP. Further, patients receive a 10-minute standardized telephone intervention during the first 4 treatment days.
(A) Ibuprofen (Ibufen-L® tablets 500 mg) orally three times daily 2 capsules for 4 days followed by an as needed regimen (days 4 - 42). The treatment duration will depend on the duration of pain. Patients are considered to be recovered when their pain is below 2 (NRS 0-10) on 2 consecutive days after they stopped the pain medication (end of treatment). (B) Standard care will be prescribed by the GP.