Efficacy of Metamizole Versus Ibuprofen and a Short Educational Intervention Versus Standard Care in Acute Low Back Pain

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The EMISI trial is a randomized, double blind, controlled trial (RCT) using a factorial design in patients with a new low back pain episode. The study aims to assess (A) whether metamizole, a non-opioid drug approved in Switzerland for pain treatment, is non-inferior to ibuprofen in a new episode of acute or subacute LBP and (B) whether a short educational intervention including evidence-based patient information is superior to usual care alone. Despite its increased use, the role of metamizole for the treatment of LBP is unclear and has so far not been systematically studied.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Analgesics; Dipyrone; Ibuprofen

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