Status:
RECRUITING
Efficacy of Metamizole Versus Ibuprofen and a Short Educational Intervention Versus Standard Care in Acute Low Back Pain
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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-opio...
Detailed Description
Purpose Low back pain (LBP) is among the top three most common diseases worldwide resulting in a life with pain-related disability. In patients with persistent LBP over 3 months, the risk for chronic ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04111315
Start Date
December 15 2019
End Date
December 31 2025
Last Update
February 7 2024
Active Locations (1)
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1
University Hospital Bern
Bern, Switzerland, 3010