The Efficacy of Dexketoprofen And Methylprednisolone in the Acute Low Back Pain (Pain)

April 15, 2025 updated by: Ali Gur
Many methods have been used in to treat low back pain. In this study, we aimed to investigate the efficacy of dexketoprofen alone and in combination with methylprednisolone in the treatment of low back pain in the emergency department using the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI).This prospective, randomized, single-blind study included 150 patients admitted to the emergency department of a university hospital. Patients with low back pain were divided in to two groups: those receiving intravenous dexketoprofen treatment (Group D) and those receiving dexketoprofen + methylprednisolone treatment (Group DM). The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48. Statistical evaluations were also undertaken on the ODI results evaluated at minute 0 and hour 48.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yakutiye
      • Erzurum, Yakutiye, Turkey, 25100
        • Ataturk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged over 18 and under 65 years.
  • The patients who presented to the emergency department with acute non-traumatic low back pain.
  • Voluntarily agreed to participate in the study.

Exclusion Criteria:

  • The patients who had used analgesics within the last six hours;
  • Who has neurological deficits, cardiac or chest pain, liver, kidney, cardiac or pulmonary failure, chronic pain,
  • Who has a history of dexketoprofen-related gastrointestinal bleeding or perforation, referred pain, neoplastic pain, a history of allergies to medications used in the study (methylprednisolone and dexketoprofen), or vision problems;
  • Who indicated a pain intensity of 3 cm or less on the 10-cm VAS scale line at the time of their presentation to the emergency department; pregnant and breastfeeding women;
  • The patients who were illiterate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Group 1 was the patients who was receiving intravenous dexketoprofen treatment in 100 saline. The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48
Drug: Dexketoprofen (KETAVEL 50 mg/2 ml)
Patients with low back pain were divided in to two groups: those receiving intravenous dexketoprofen treatment (Group 1) and those receiving dexketoprofen + methylprednisolone treatment (Group 2). The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48. Statistical evaluations were also undertaken on the ODI results evaluated at minute 0 and hour 48.
Active Comparator: Group 2
Group 2 was the patients who was receiving intravenous dexketoprofen combined with methylprednisolone treatment in 100 saline. The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48.
Combination product: Methylprednisolone (Corticosteroid)
Patients with low back pain were divided in to two groups: those receiving intravenous dexketoprofen treatment (Group 1) and those receiving dexketoprofen + methylprednisolone treatment (Group 2). The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48. Statistical evaluations were also undertaken on the ODI results evaluated at minute 0 and hour 48.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) score
Time Frame: 48 hours
The primary outcome of the study was the pain scores of the groups according to the Visual Analog Scale (VAS) scores. Lower VAs score below 4 is assigned as the lower pain value of the participants, whereas, higer vaslus of VAS score close to 10 accepted as higher pain value described from the participants
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI)
Time Frame: 48 hours

The secondary outcome was the effect of dexketoprofen alone and in combination with methylprednisolone on low back pain-related disability, according to the Oswestry Disability Index (ODI)scores.

While interpreting the ODI score, the the scores are considered as:

0% to 20% - minimal disability 20% to 40% - moderate disability 40% to 60% - severe disability 60% to 80% - crippled 80% to 100% - bed bound (or exaggerating symptoms).
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ali Gur

Investigators

  • Principal Investigator: Mehmet Meral Ataturk University Medical Faculty, Emergency Department, M.D., Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

January 2, 2025

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA0.01.00/286
  • TTU-2021-9373 (Other Grant/Funding Number: Ataturk University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data that support the findings of this study are available from the corresponding author, upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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