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

NCT04111315 | Recruiting Phase 4

• 1 other identifier: 2018-01986
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Pain medications; Non-opioid pain medications; Educational intervention

Outcome Measures

Primary Outcomes (2)

• Pain improvement

  Change in pain on the numeric rating scale (NRS, range 0 (no pain) -10 (worst possible pain) points)

  Baseline to 14 days follow-up

• Disability

  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.

  Baseline to 42 days follow-up

Study Arms (4)

metamizole + educational intervention

ACTIVE COMPARATOR

(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; Behavioral: Patient education

metamizole + standard care

ACTIVE COMPARATOR

(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

ibuprofen + educational intervention

ACTIVE COMPARATOR

(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; Behavioral: Patient education

ibuprofen + standard care

ACTIVE COMPARATOR

(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

Interventions

Metamizole Sodium DRUG

Novalgin® Oblong tablets 0,5 g 2-2-2

Also known as: Metamizole

metamizole + educational intervention; metamizole + standard care

Ibuprofen 600 mg DRUG

Ibufen-L® tablets 500 mg 2-2-2

Also known as: Ibuprofen

ibuprofen + educational intervention; ibuprofen + standard care

Patient education BEHAVIORAL

Leaflet and phone call

Also known as: Education

ibuprofen + educational intervention; metamizole + educational intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

RECRUITING

Related Publications (2)

• Wertli MM, Flury JS, Streit S, Limacher A, Schuler V, Ferrante AN, Rimensberger C, Haschke M. Efficacy of metamizole versus ibuprofen and a short educational intervention versus standard care in acute and subacute low back pain: a study protocol of a randomised, multicentre, factorial trial (EMISI trial). BMJ Open. 2021 Oct 13;11(10):e048531. doi: 10.1136/bmjopen-2020-048531.

  PMID: 34645660 BACKGROUND

• Jermini-Gianinazzi I, Blum M, Trachsel M, Trippolini MA, Tochtermann N, Rimensberger C, Liechti FD, Wertli MM. Management of acute non-specific low back pain in the emergency department: do emergency physicians follow the guidelines? Results of a cross-sectional survey. BMJ Open. 2023 Aug 4;13(8):e071893. doi: 10.1136/bmjopen-2023-071893.

  PMID: 37541755 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Dipyrone; Ibuprofen; Patient Education as Topic; Educational Status

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Maria M. Wertli, MD PhD

  University of Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria M. Wertli, MD PhD

CONTACT

+41796576420; Maria.Wertli@insel.ch

Nathalie Schwab

CONTACT

+41775323582; nathalie.schwab@insel.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Comparison (A): participants, care provider, and Investigators will be blinded Comparison (B): Investigators will be blinded
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 1, 2019
• Study Start: December 15, 2019
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

CH (1)