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| ID | Type | Description | Link |
|---|---|---|---|
| TTU-2021-9373 | Other Grant/Funding Number | Ataturk University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index (ODI) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet Meral Ataturk University Medical Faculty, Emergency Department, M.D. | Ataturk University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ataturk University | Erzurum | Yakutiye | 25100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40765043 | Derived | 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. |
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The data that support the findings of this study are available from the corresponding author, upon reasonable request.
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C118296 | dexketoprofen trometamol |
| D008775 | Methylprednisolone |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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|
| 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. |
|
| 48 hours |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |