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

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ClinicalTrials.gov Identifier: NCT04111315
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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-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.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Metamizole Sodium Drug: Ibuprofen 600 mg Behavioral: Patient education Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Patients are assigned into one of the four groups metamizole + educational intervention metamizole + standard care ibuprofen + educational intervention ibuprofen + standard care Comparison (A): metamizole vs. ibuprofen for pain (NRS) at day 14 Comparison (B): short educational interventions vs. standard care for Disability (COMI) at day 42
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Comparison (A): participants, care provider, and Investigators will be blinded Comparison (B): Investigators will be blinded
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 13, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: metamizole + educational intervention

(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.

Drug: Metamizole Sodium
Novalgin® Oblong tablets 0,5 g 2-2-2
Other Name: Metamozole

Behavioral: Patient education
Leaflet and phone call
Other Name: Education

Active Comparator: metamizole + 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) Standard care will be prescribed by the GP.

Drug: Metamizole Sodium
Novalgin® Oblong tablets 0,5 g 2-2-2
Other Name: Metamozole

Active Comparator: ibuprofen + educational intervention

(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.

Drug: Ibuprofen 600 mg
Ibufen-L® tablets 500 mg 2-2-2
Other Name: Ibuprofen

Behavioral: Patient education
Leaflet and phone call
Other Name: Education

Active Comparator: ibuprofen + standard care

(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.

Drug: Ibuprofen 600 mg
Ibufen-L® tablets 500 mg 2-2-2
Other Name: Ibuprofen




Primary Outcome Measures :
  1. Pain improvement [ Time Frame: Baseline to 14 days follow-up ]
    Change in pain on the numeric rating scale (NRS, range 0 (no pain) -10 (worst possible pain) points)

  2. Disability [ Time Frame: Baseline to 42 days follow-up ]
    Change in the Core Outcome Measures Index (COMI) sum-score (range 0-10). COMI sum score (0-10 points) is calculated by averaging the five domain scores (each on a 0-10 scale) for pain, back-related function, symptom-specific well-being, general quality of life and disability. Higher values represent a better or worse outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111315


Contacts
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Contact: Maria M. Wertli, MD PhD +41796576420 Maria.Wertli@insel.ch
Contact: Nathalie Schwab +41775323582 nathalie.schwab@insel.ch

Locations
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Switzerland
University Hospital Bern Recruiting
Bern, Switzerland, 3010
Contact: Maria M. Wertli    +41796576420 ext +41796576420    Maria.Wertli@insel.ch   
Contact: Nathalie Schwab    +41775323582 ext +41775323582    EMISI@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Maria M. Wertli, MD PhD University of Bern
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04111315    
Other Study ID Numbers: 2018-01986
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Depending on the data privacy regulation, we aim to make individual participant data available opon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The study protocol will be made available upon request and will be shared as soon as the trial results are published.
Access Criteria: Contact the principal investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
Pain medications
Non-opioid pain medications
Educational intervention
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Dipyrone
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics