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

NCT06932367 | Completed Phase 4

• 2 other identifiers: B.30.2.ATA0.01.00/286TTU-2021-9373
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

Low back pain; Dexketoprofen; Methylprednisolone; Visual Analog Scale; Oswestry Disability Index

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) score

  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 Outcomes (1)

• Oswestry Disability Index (ODI)

  48 hours

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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)

Group 2

ACTIVE COMPARATOR

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)

Interventions

Dexketoprofen (KETAVEL 50 mg/2 ml) DRUG

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.

Group 1

Methylprednisolone (Corticosteroid) COMBINATION_PRODUCT

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.

Group 2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ali Gur: lead

Study Sites (1)

Ataturk University

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Location

Related Publications (1)

• Meral M, Gur A. A comparative study on the efficacy of dexketoprofen and methylprednisolone in the treatment of acute low back pain. BMC Emerg Med. 2025 Aug 5;25(1):147. doi: 10.1186/s12873-025-01276-y.

  PMID: 40765043 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

dexketoprofen trometamol; Methylprednisolone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

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

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 17, 2025
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: January 2, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)