Efficacy of metamizole compared to ibuprofen and a short training compared to standard treatment by the general practitioner in acute and subacute lumbar back pain: a randomized, factorial study
Summary description of the study
Pain in the lower back (lumbar pain) is very common. Almost everyone suffers at least once from an acute episode of lumbar pain. In the first weeks, treatment guidelines recommend, in addition to symptomatic treatment with pain medication, physical exercise. However, many of the pain medications used today have not been or have been poorly studied for this indication. Ibuprofen, a non-steroidal anti-inflammatory drug, is effective in many pain situations and is frequently used. Metamizole, an effective pain medication that is well tolerated, is also commonly used. However, the efficacy of metamizole in back pain has not been systematically studied so far. The aim of this study is to compare the efficacy of metamizole with that of ibuprofen. Regular physical exercise is also recommended, as studies have shown that it helps with recovery. However, many patients are reluctant to take medication, avoiding pain-triggering movements and resting, which negatively affects their back pain. This study also investigates whether a brief consultation (short intervention) in addition to pain therapy improves function after 6 weeks. This study will therefore clarify the role of metamizole in the treatment of back pain. If the short intervention is successful, the study also has the potential to improve the treatment of acute and subacute back pain with simple means.
(BASEC)
Intervention under investigation
This study investigates two interventions: A) metamizole is compared with the standard treatment ibuprofen for pain relief B) it is examined whether a short training on back pain has an effect in addition to the standard treatment by general practitioners.
(BASEC)
Disease under investigation
New episode of acute or subacute lumbar back pain
(BASEC)
Adults (18 years or older) who visit the general practitioner for a new episode of lumbar pain lasting less than 12 weeks and for whom treatment with a non-opioid pain medication is planned are included. (BASEC)
Exclusion criteria
Known intolerance or contraindications to the use of metamizole and/or ibuprofen. Active tumor disease or a history of hematological disease. Current opioid use. Medications that weaken the immune system (immunosuppression with, for example, corticosteroids) or weakness of the immune system. (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
Inselspital Bern Klinik für Allgemeine Innere Medizin (KAIM)
(BASEC)
Contact
Contact Person Switzerland
Maria Wertli
+41796576420
Maria.Wertli@clutterksb.chInselspital Bern Klinik für Allgemeine Innere Medizin (KAIM)
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
30.06.2021
(BASEC)
ICTRP Trial ID
NCT04111315 (ICTRP)
Official title (approved by ethics committee)
Efficacy of metamizole versus ibuprofen and a short educational intervention versus standard care in acute and subacute low back pain: a randomised, factorial trial (EMISI trial) (BASEC)
Academic title
Efficacy of Metamizole Versus Ibuprofen and a Short Educational Intervention Versus Standard Care in Acute and Subacute Low Back Pain: A Randomized, Factorial Trial (ICTRP)
Public title
Efficacy of Metamizole Versus Ibuprofen and a Short Educational Intervention Versus Standard Care in Acute Low Back Pain (ICTRP)
Disease under investigation
Low Back Pain (ICTRP)
Intervention under investigation
Drug: Metamizole Sodium;Drug: Ibuprofen 600 mg;Behavioral: Patient education (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 18 Years
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
(ICTRP)
not available
Primary and secondary end points
Pain improvement;Disability (ICTRP)
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Maria M. Wertli, MD PhD;Maria M. Wertli, MD PhD;Maria M. Wertli, Maria.Wertli@insel.ch, +41796576420;+41796576420, University of Bern, (ICTRP)
Secondary trial IDs
2018-01986 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT04111315 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available