A Comparative Study on the Efficacy of Dexketoprofen and Methylprednisolone in the Treatment of Acute Low Back Pain

A Comparative Study on the Efficacy of Dexketoprofen and Methylprednisolone in the Treatment of Acute Low Back Pain | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article A Comparative Study on the Efficacy of Dexketoprofen and Methylprednisolone in the Treatment of Acute Low Back Pain Mehmet MERAL, Ali GUR This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6243015/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 05 Aug, 2025 Read the published version in BMC Emergency Medicine → Version 1 posted 13 You are reading this latest preprint version Abstract Background: 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). Methods: 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. Results: The VAS scores decreased in both groups at all follow-up evaluations performed throughout the treatment (p<0.05). The mean VAS score evaluated 48 hours after treatment was 1.69±1.71 cm in Group DM and 4.13±2.27 cm in Group D (p=0.000). The decrease in the ODI score was greater in Group DM than in Group D (p=0.000). Conclusion: Dexketoprofen showed analgesic efficacy in the treatment of non-traumatic low back pain and decreased disability. When combined with methylprednisolone, dexketoprofen treatment exhibit a greater analgesic effect and further reduced disability. Trial registration: Current Controlled Trials NCT06932367 (Retrospectively registered) Low back pain Dexketoprofen Methylprednisolone Visual Analog Scale Oswestry Disability Index Figures Figure 1 Figure 2 1. Introduction Low back pain is a common health problem across the world. Despite being commonly perceived as an insignificant symptom among individuals and society, low back pain is a prevalent health issue that can have serious implications in terms of both health expenses and loss of workforce. [ 1 – 3 ] Various factors can contribute to the occurrence of low back pain. In order to ensure accurate and effective treatment, the causes of low back pain must be determined through a comprehensive assessment that includes medical history, physical examination findings, and, if necessary, radiographic imaging findings. [ 4 ] The treatment of lumbar pain requires a multidisciplinary approach 5 . Non-pharmacological, pharmacological, minimally invasive interventions, or surgical methods are recommended depending on the patient’s clinical findings and the red or yellow flag signs specified by the relevant guidelines [ 6 ] . Non-pharmacological therapeutic modalities include massage, acupuncture, hot-cold applications, psychotherapies, yoga, Tai Chi, movement control exercises, spinal manipulation therapy, exercise therapies, and gradual activity programs. [ 7 – 12 ] Muscle relaxants, non-steroidal anti-inflammatory drugs (NSAIDs), opioids, tricyclic antidepressants (TCAs), and antiepileptic drugs are used in pharmacological treatment. [ 13 – 16 ] 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). 2. Material and Method 2.1 Study Design and Setting This study was conducted as a prospective, randomized, single-blind study at the emergency department of a university hospital from August 1, 2021, through August 1, 2022. The analgesic efficacy of intravenous dexketoprofen (Arveles©) and dexketoprofen + methylprednisolone (Arveles© + Precort©) was compared in patients with low back pain. The study was initiated after receiving approval from the Clinical Research Ethics Committee of the Atatürk University Faculty of Medicine (date: June 24, 2021, decision number 286). Patients were accepted into the study after obtaining informed consent from them or their relatives based on voluntariness. Our study was conducted in accordance with CONSORT guidelines. The study protocol followed the tenets of the Declaration of Helsinki. 2.2 Sample Size and Patients G-Power 3.1 software was used to calculate the sample size required for the study. The sample size was calculated using a medium effect size of 0.5, a type 1 error of 0.05, and a power value of 0.80. As a result, the required sample size was determined to be at least 62 patients in each group, considering the possibility of a 10% loss. A total of 150 volunteer patients, 75 in each group, were included in the study. Patients aged over 18 and under 65 years who presented to the emergency department with acute non-traumatic low back pain and agreed to participate in the study were evaluated for eligibility. Excluded from the study were patients who had used analgesics within the last six hours; those with neurological deficits, cardiac or chest pain, liver, kidney, cardiac or pulmonary failure, chronic pain, 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; those 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; and patients who were illiterate. 2.3 Randomization and Primary Outcome The patients were divided into two groups: the dexketoprofen-administered group (Group D) and the dexketoprofen + methylprednisolone-administered group (Group DM). The patients were allocated to the medication groups based on the patient scale generated on the website https://www.randomizer.org/#randomize . The patients were not informed of their assigned group. The primary outcome of the study was the pain scores of the groups according to the VAS scores. The secondary outcome was the effect of dexketoprofen alone and in combination with methylprednisolone on low back pain-related disability, according to the ODI scores. 2.4 Study Variables and Intervention The patients participating in the study were evaluated in the yellow triage category. After a systemic examination, a 16-gauge intravenous catheter was inserted into the patient by an experienced nurse. Before administering the assigned drug intravenously, a 10-cm VAS evaluation was undertaken as a standard method proven to be reliable in measuring the severity of low back pain. The VAS was explained to volunteer patients in detail, and they were asked to self-evaluate on a scale of 0 to 10, with 0 indicating the absence of any pain and 10 cm representing the most severe pain. The patients were also asked to complete the ODI questionnaire before starting treatment and 48 hours after treatment. Using this scale, the patients’ pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and traveling were questioned. Each criterion was scored on its own and evaluated out of 100 points. Treatment was started after the patients self-evaluated their VAS scores. The VAS and ODI scores of the patients were recorded at minute 0, referring to the start of treatment. The vital signs of the patients were routinely obtained at minutes 15, 30, and 60 and were kept under close monitoring for possible complications. During this period, the VAS scores were also questioned and recorded at minutes 15, 30, and 60. After the follow-up and treatment in the emergency department, the patients were discharged and asked to return to the emergency department for re-evaluation 48 hours later. When the patients arrived at the emergency department, their 48th-hour VAS scores and ODI scores were questioned. Group D was intravenously administered 50 mg of dexketoprofen in 100 ml of physiological saline for 30 minutes. Group DM was intravenously administered 50 mg of dexketoprofen plus 1 mg/kg of methylprednisolone in 100 ml of physiological saline for 30 minutes. All patients’ VAS scores were evaluated at minutes 0, 15, 30, and 60 and hour 48; their ODI scores were evaluated at minute 0 and hour 48; and their vital signs were evaluated at minutes 15, 30, and 60. These data were then compared using statistical methods. 2.5 Statistical Analysis The obtained data were transferred to the computer environment and analyzed using the SPSS v. 25.0 (SPSS, Inc., Chicago, IL) package program. Data were presented as mean, standard deviation, median, minimum, maximum, percentage, and number. The normality of the distribution of continuous variables was examined with the Shapiro-Wilk W test when the sample size was < 50, and the Kolmogorov-Smirnov test when the sample size was ≥ 50. In comparisons between two independent groups, the independent-samples t-test was used if the normal distribution condition was met, and the Mann-Whitney U test was used otherwise. In 2x2 comparisons between categorical variables, the Pearson chi-square test was conducted if the expected value was > 5, the chi-square Yates test if the expected value was between 3 and 5, and the Fisher’s exact test if the expected value was 5, and the Fisher-Freeman-Halton test was used when the expected value was < 5. P < 0.05 was considered statistically significant. 3. Results 3.1. Patient populations and characteristics Treatment was applied to 178 patients who presented to the emergency department; however, 28 patients were excluded from the study since they did not visit the emergency department at the 48th hour. As a result, 150 patients were included in the sample. The demographic and characteristic features of the patients are given in Table-1. Male patients constituted 65.3% of the patients in Group D and 54.7% of those in Group DM. The mean age was 34.89 ± 10.92 years for Group D and 40.84 ± 10.93 years for Group DM. In Group D, the mean systolic blood pressure was 129.35 ± 17.36 mmHg, the mean diastolic blood pressure was 81.89 ± 12.49 mmHg, the mean respiratory rate was 15.2 ± 1.79 per minute, the mean oxygen saturation was 94.85 ± 2%, and the mean pulse was 89.64 ± 16.95 per minute, while for Group DM, these values were determined to be 126.73 ± 16.66 mmHg, 76.17 ± 12.11 mmHg, 17.24 ± 9.65 per minute, 94.69 ± 2.56%, and 82.28 ± 12.92 beats per minute, respectively. 3.2. Comparison of groups The pain sensations of patients who presented to the emergency department with complaints of non-traumatic low back pain were evaluated using the VAS. The mean baseline (minute 0) VAS scores of Group D and Group DM were 8.12 ± 1.59 and 7.49 ± 1.81 cm, respectively. Accordingly, the VAS score of the patients in Group D was significantly higher than that of those in Group DM at baseline (p = 0.032). The VAS scores evaluated during the follow-up period after starting treatment exhibited a decrease in both groups (p < 0.05 in all follow-up evaluations). The mean VAS score evaluated 48 hours after treatment was 1.69 ± 1.71 cm for Group DM and 4.13 ± 2.27 cm for Group D, indicating a statistically significant difference between the groups (p = 0.000). The mean decrease from the baseline to hour 48 was 3.99 units for Group D versus 5.8 units for Group DM (Table 2 ). This suggested that dexketoprofen + methylprednisolone had greater analgesic efficacy. Figure 1 presents the comparison of the VAS scores of the groups according to the follow-up evaluation time. Table 1 Demographic and clinical characteristics of the groups Group D Group DM p Age (years), (mean, SD) 34.89 ± 10.92 40.84 ± 10.93 0.000 Gender Male 49 (65.3%) 41 (54.7%) 0.182 Female 26 (34.7%) 34 (45.3%) Chronic disease history Present 6 (8%) 12 (16%) 0.132 Absent 69 (92%) 63 (84%) Straight leg raise test Positive 22 (29.3%) 38 (50.7%) 0.008 Negative 53 (70.3%) 37 (49.3%) Urinary incontinence Present 0 (0%) 1 (1.3%) 0.316 Absent 100 (100%) 74 (98.7%) Systolic blood pressure (mmHg) 129.35 ± 17.36 126.73 ± 16.66 0.588 Diastolic blood pressure (mmHg) 81.89 ± 12.49 76.17 ± 12.11 0.007 Respiratory rate (/min) 15.2 ± 1.79 17.24 ± 9.65 0.012 Oxygen saturation (%) 94.85 ± 2 94.69 ± 2.56 0.691 Pulse (beat/min) 89.64 ± 16.95 82.28 ± 12.92 0.011 Group D: dexketoprofen-administered group; Group DM: dexketoprofen + methylprednisolone-administered group; SD: standard deviation Table 2 Evaluation of the VAS scores of the groups VAS (cm) Group D Group DM p Baseline (minute 0), median (min-max) 8 (4–10) 7 (2–10) 0.032 Minute 15 7 (1–10) 5 (0–10) 0.001 Minute 30 5 (0–10) 4 (0–10) 0.000 Minute 60 4 (0–10) 2 (0–9) 0.000 Hour 48 4 (0–10) 1 (0–8) 0.000 VAS: Visual Analog Scale; Group D: dexketoprofen-administered group; Group DM: dexketoprofen + methylprednisolone-administered group; min: minimum; max: maximum The patients’ ODI scores were determined at the time of presentation to the hospital (minute 0) and 48 hours after treatment. According to the data obtained, the mean baseline ODI score of Group DM was 43.95 ± 22.09, which was higher than that of Group D, but it did not result in a statistically significant difference (p = 0.514). According to the re-evaluation made 48 hours after the application of the allocated treatments, there was a decrease in the ODI scores of both groups (mean ODI score: 33.27 ± 23.31 for Group D and 18.67 ± 14.44 for Group DM), and the efficacy of the treatments increased. The decrease in the ODI score was greater in Group DM than in Group D, and this was at a statistically significant level (p = 0.000) (Table 3 ). The comparison of the ODI scores of the groups according to the evaluation time is given in Fig. 2 . Table 3 Evaluation of the ODI scores of the groups ODI score (%) Group D Group DM p Baseline (minute 0), median (min-max) 40 (4–92) 40 (6-100) 0.514 Hour 48 31 (0-116) 16 (0–72) 0.000 VAS: Visual Analog Scale; Group D: dexketoprofen-administered group; Group DM: dexketoprofen + methylprednisolone-administered group; min: minimum; max: maximum 4. Discussion It is known that NSAIDs are the first pharmacological agents to be preferred in the treatment of low back pain, while corticosteroids alone are not useful for this purpose. Our study is one of the first investigations on the analgesic and functional effects of NSAIDs and corticosteroids in combination therapy. Our results showed that NSAIDs had an analgesic effect on low back pain, but when used in combination with corticosteroids, the pain intensity of the patients further decreased. Pharmacological treatments are administered to patients who have a history of low back pain, those who refrain from non-pharmacological approaches, or those who are at risk of developing serious complications related to low back pain. As per the recommendations of the American Medical Association, it is advised to initiate NSAIDs and muscle relaxants as a first step in pharmacological therapy. [ 16 ] In a systematic review of patients treated for low back pain, the analgesic efficacy of pharmacological agents in the NSAID group was evaluated in patients aged 18–65 years. [ 17 ] Other studies including patients suffering from acute and chronic low back pain without a specific cause evaluated analgesic effect and disability status after oral piroxicam treatment, [ 18 ] analgesic effect and functional capacity after intramuscular tenoxicam injection, [ 19 ] and the analgesic effect after intravascular diclofenac treatment. [ 20 ] Systematic evaluations have determined that the use of NSAIDs in both acute and chronic low back pain provides adequate analgesia and significantly improves physical capability. [ 17 ] Many studies have been conducted on the use of dexketoprofen for analgesia. The analgesic effects of paracetamol and ibuprofen, [ 21 ] diclofenac sodium, [ 22 ] placebo, [ 23 ] and morphine [ 24 ] have been compared in low back pain. These studies have found that dexketoprofen exhibited either a greater analgesic effect [ 21 , 23 ] or had no difference [ 22 , 24 ] when compared to other agents. In our study, the use of dexketoprofen alone in low back pain had analgesic efficacy, similar to previous studies. Corticosteroids are another type of pharmacological agent used in individuals with acute or chronic low back pain. The analgesic effect of corticosteroids has also been investigated. However, there are only a limited number of studies comparing their analgesic effects to those of other agents for low back pain. In a study investigating the efficacy of oral prednisolone treatment alone in low back pain, no significant difference was found compared to the control group. [ 25 , 26 ] In another study, intramuscular methylprednisolone and placebo groups were compared in patients who presented to the emergency department with low back pain, and methylprednisolone was found to have an analgesic effect. [ 27 ] We observed significant reductions in VAS scores at minutes 15, 30, and 60 and hour 48 compared to the initial measurement at minute 0. Additionally, the patients with high levels of baseline disability had a significant decrease in their ODI scores after treatment. Although the research in the literature has proven that the use of corticosteroids alone is not useful for low back pain, there are a few studies showing its benefits. The functionality and analgesic effects of intramuscular methylprednisolone treatment were investigated in patients who presented to the emergency department with low back pain and had a positive straight leg raise test. It was observed that the additional analgesic medication requirements and pain complaints of the corticosteroid-treated group decreased compared to the control group. [ 28 ] In another study, the benefits of oral steroid treatment for the relief of pain caused by sciatic injury were investigated. In the comparison performed between the control group and patients receiving oral steroid treatment, it was observed that the ODI scores decreased rapidly and functionality improved in the latter during the follow-up period. It was also determined that the patients treated with methylprednisolone have less need for additional analgesic medication. [ 29 ] In the current study, we found a greater level of decrease in the ODI scores of patients who were administered dexketoprofen + methylprednisolone than in those who received dexketoprofen alone. The literature also contains studies investigating the combinations of NSAIDs and steroids for different analgesic effects. It has been determined that a steroid combination was more effective for analgesia in patients with plantar fasciitis. [ 30 ] In a study comparing the efficacy of NSAIDs and prednisolone in the management of postoperative pain in patients undergoing tonsillectomy, the use of steroids was shown to increase postoperative comfort. [ 31 ] In the current study, it was determined that the analgesic effect of steroid use together with NSAIDs was greater than in previous studies. 5. Limitations There are some limitations to our study, with the most important being its single-center design and small sample size. Another limitation is that pain intensity was determined according to patient accounts, making it a subjective evaluation. Furthermore, our study is limited by the absence of a placebo group and the brief duration in which we assessed the efficacy of symptomatic treatment. 6. Conclusion This study demonstrated that dexketoprofen had analgesic activity and reduced disability in the treatment of patients who present to the emergency department due to non-traumatic low back pain. When used in combination with methylprednisolone, dexketoprofen exhibited greater analgesic efficacy and resulted in the faster regression of disability. Therefore, it is concluded that the combined use of NSAIDs and steroids yields a greater analgesic effect in the management of patients who present to the emergency department with non-traumatic low back pain. Declarations Ethics approval and consent to participate: This study was approved by Clinical Research Ethics Committee of the Atatürk University Faculty of Medicine (date: June 24, 2021, decision number 286). Patients were accepted into the study after obtaining informed consent from them or their relatives based on voluntariness. The study protocol followed the tenets of the Declaration of Helsinki. Clinical trial number: Not applicable Consent for publication: Not applicable Funding: This study was financially supported by the Scientific Research Projects (BAP) Unit of Atatürk University with the project code TTU-2021-9373. Conflict of Interest: The authors have no conflict of interest to declare. References Murray CJ, Lopez AD, Organization WH. The global burden of disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020: summary: World Health Organization; 1996. 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JPMA The Journal of the Pakistan Medical Association. 2022;72(2):231-5 Aveline C, Le Hetet H, Le Roux A, Bonnet F. A survey of the administration of prednisolone versus ibuprofen analgesic protocols after ambulatory tonsillectomy. Anaesthesia, critical care & pain medicine. 2015;34(5):281-7. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 05 Aug, 2025 Read the published version in BMC Emergency Medicine → Version 1 posted Editorial decision: Revision requested 19 May, 2025 Reviews received at journal 18 May, 2025 Reviews received at journal 15 May, 2025 Reviews received at journal 01 May, 2025 Reviewers agreed at journal 26 Apr, 2025 Reviewers agreed at journal 25 Apr, 2025 Reviewers agreed at journal 24 Apr, 2025 Reviewers agreed at journal 24 Apr, 2025 Reviewers invited by journal 24 Apr, 2025 Editor assigned by journal 18 Apr, 2025 Editor invited by journal 18 Apr, 2025 Submission checks completed at journal 17 Apr, 2025 First submitted to journal 17 Apr, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6243015","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":448685213,"identity":"873202e8-7b7b-42aa-9651-9695f7f96802","order_by":0,"name":"Mehmet MERAL","email":"","orcid":"","institution":"Atatürk University","correspondingAuthor":false,"prefix":"","firstName":"Mehmet","middleName":"","lastName":"MERAL","suffix":""},{"id":448685215,"identity":"008f17bc-8ab7-41f7-98c1-e68817517c50","order_by":1,"name":"Ali GUR","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA7klEQVRIiWNgGAWjYDCCA2xgSgZMfQBiNnbCWhgbgBQPSAvjDJAWZmK1gNjMEJKADr7jbekPPu6x4+HjX2P22ebXNnk+ZgbGDx9zcGuRPHPsYOOMZ8k8bBJvjGfn9t02bGNmYJacuQ23FoMb6Y3NPAeYgVrOGDPn9txmBGphY+YlrKUeosWy57Y9EVrSDgK1HOZh4+8xZmb4cTuRoBagXxJnzjhwHGgLWzFjb8Pt5DZmxma8fgGGmMGHDweq5eT7D29m+PHntu389uaDHz7i0YIAEgnAuGwDscARRQzgPwAk/hCpeBSMglEwCkYUAAA6pE+zyltIgwAAAABJRU5ErkJggg==","orcid":"","institution":"Atatürk University","correspondingAuthor":true,"prefix":"","firstName":"Ali","middleName":"","lastName":"GUR","suffix":""}],"badges":[],"createdAt":"2025-03-17 09:23:16","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6243015/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6243015/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12873-025-01276-y","type":"published","date":"2025-08-05T15:58:08+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":82125272,"identity":"235626cb-fc4c-4076-a295-63c94f9438f4","added_by":"auto","created_at":"2025-05-07 03:46:58","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":18050,"visible":true,"origin":"","legend":"\u003cp\u003eComparison of the groups according to the VAS scores (Group D: dexketoprofen-administered group; Group DM: dexketoprofen + methylprednisolone-administered group; VAS: Visual Analog Scale)\u003c/p\u003e","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6243015/v1/e706f3db8462032bbd946d93.jpg"},{"id":82122963,"identity":"c10166e2-eda4-4aed-96ef-879a1aa3d49e","added_by":"auto","created_at":"2025-05-07 03:30:58","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":17035,"visible":true,"origin":"","legend":"\u003cp\u003eComparison of the groups according to the ODI scores (Group D: dexketoprofen-administered group; Group DM: dexketoprofen + methylprednisolone-administered group; ODI: Oswestry Disability Index)\u003c/p\u003e","description":"","filename":"Figure2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6243015/v1/eebe78a87c6b3073e7d1109f.jpg"},{"id":88814937,"identity":"e7acb9b8-e701-4134-a7b9-ac13b4d17c79","added_by":"auto","created_at":"2025-08-11 16:10:20","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":621098,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6243015/v1/e787f66f-1f2b-4bff-b5cd-47dcb46c2d29.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eA Comparative Study on the Efficacy of Dexketoprofen and Methylprednisolone in the Treatment of Acute Low Back Pain\u003c/p\u003e","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003e\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eLow back pain is a common health problem across the world. Despite being commonly perceived as an insignificant symptom among individuals and society, low back pain is a prevalent health issue that can have serious implications in terms of both health expenses and loss of workforce. \u003csup\u003e[\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e\u003c/p\u003e\u003cp\u003eVarious factors can contribute to the occurrence of low back pain. In order to ensure accurate and effective treatment, the causes of low back pain must be determined through a comprehensive assessment that includes medical history, physical examination findings, and, if necessary, radiographic imaging findings.\u003csup\u003e[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003e The treatment of lumbar pain requires a multidisciplinary approach\u003csup\u003e5\u003c/sup\u003e. Non-pharmacological, pharmacological, minimally invasive interventions, or surgical methods are recommended depending on the patient\u0026rsquo;s clinical findings and the red or yellow flag signs specified by the relevant guidelines \u003csup\u003e[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]\u003c/sup\u003e. Non-pharmacological therapeutic modalities include massage, acupuncture, hot-cold applications, psychotherapies, yoga, Tai Chi, movement control exercises, spinal manipulation therapy, exercise therapies, and gradual activity programs.\u003csup\u003e[\u003cspan additionalcitationids=\"CR8 CR9 CR10 CR11\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]\u003c/sup\u003e Muscle relaxants, non-steroidal anti-inflammatory drugs (NSAIDs), opioids, tricyclic antidepressants (TCAs), and antiepileptic drugs are used in pharmacological treatment.\u003csup\u003e[\u003cspan additionalcitationids=\"CR14 CR15\" citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]\u003c/sup\u003e\u003c/p\u003e\u003cp\u003eIn 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).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e"},{"header":"2. Material and Method","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e2.1 Study Design and Setting\u003c/h2\u003e \u003cp\u003e\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eThis study was conducted as a prospective, randomized, single-blind study at the emergency department of a university hospital from August 1, 2021, through August 1, 2022. The analgesic efficacy of intravenous dexketoprofen (Arveles\u0026copy;) and dexketoprofen\u0026thinsp;+\u0026thinsp;methylprednisolone (Arveles\u0026copy; + Precort\u0026copy;) was compared in patients with low back pain. The study was initiated after receiving approval from the Clinical Research Ethics Committee of the Atat\u0026uuml;rk University Faculty of Medicine (date: June 24, 2021, decision number 286). Patients were accepted into the study after obtaining informed consent from them or their relatives based on voluntariness. Our study was conducted in accordance with CONSORT guidelines. The study protocol followed the tenets of the Declaration of Helsinki.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003e2.2 Sample Size and Patients\u003c/h2\u003e \u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eG-Power 3.1 software was used to calculate the sample size required for the study. The sample size was calculated using a medium effect size of 0.5, a type 1 error of 0.05, and a power value of 0.80. As a result, the required sample size was determined to be at least 62 patients in each group, considering the possibility of a 10% loss. A total of 150 volunteer patients, 75 in each group, were included in the study.\u003c/p\u003e \u003cp\u003ePatients aged over 18 and under 65 years who presented to the emergency department with acute non-traumatic low back pain and agreed to participate in the study were evaluated for eligibility. Excluded from the study were patients who had used analgesics within the last six hours; those with neurological deficits, cardiac or chest pain, liver, kidney, cardiac or pulmonary failure, chronic pain, 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; those 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; and patients who were illiterate.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003e2.3 Randomization and Primary Outcome\u003c/h2\u003e \u003cp\u003eThe patients were divided into two groups: the dexketoprofen-administered group (Group D) and the dexketoprofen\u0026thinsp;+\u0026thinsp;methylprednisolone-administered group (Group DM). The patients were allocated to the medication groups based on the patient scale generated on the website \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.randomizer.org/#randomize\u003c/span\u003e\u003cspan address=\"https://www.randomizer.org/#randomize\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. The patients were not informed of their assigned group. The primary outcome of the study was the pain scores of the groups according to the VAS scores. The secondary outcome was the effect of dexketoprofen alone and in combination with methylprednisolone on low back pain-related disability, according to the ODI scores.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003e2.4 Study Variables and Intervention\u003c/h2\u003e \u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eThe patients participating in the study were evaluated in the yellow triage category. After a systemic examination, a 16-gauge intravenous catheter was inserted into the patient by an experienced nurse. Before administering the assigned drug intravenously, a 10-cm VAS evaluation was undertaken as a standard method proven to be reliable in measuring the severity of low back pain. The VAS was explained to volunteer patients in detail, and they were asked to self-evaluate on a scale of 0 to 10, with 0 indicating the absence of any pain and 10 cm representing the most severe pain. The patients were also asked to complete the ODI questionnaire before starting treatment and 48 hours after treatment. Using this scale, the patients\u0026rsquo; pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and traveling were questioned. Each criterion was scored on its own and evaluated out of 100 points. Treatment was started after the patients self-evaluated their VAS scores. The VAS and ODI scores of the patients were recorded at minute 0, referring to the start of treatment. The vital signs of the patients were routinely obtained at minutes 15, 30, and 60 and were kept under close monitoring for possible complications. During this period, the VAS scores were also questioned and recorded at minutes 15, 30, and 60. After the follow-up and treatment in the emergency department, the patients were discharged and asked to return to the emergency department for re-evaluation 48 hours later. When the patients arrived at the emergency department, their 48th-hour VAS scores and ODI scores were questioned. Group D was intravenously administered 50 mg of dexketoprofen in 100 ml of physiological saline for 30 minutes. Group DM was intravenously administered 50 mg of dexketoprofen plus 1 mg/kg of methylprednisolone in 100 ml of physiological saline for 30 minutes. All patients\u0026rsquo; VAS scores were evaluated at minutes 0, 15, 30, and 60 and hour 48; their ODI scores were evaluated at minute 0 and hour 48; and their vital signs were evaluated at minutes 15, 30, and 60. These data were then compared using statistical methods.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003e2.5 Statistical Analysis\u003c/h2\u003e \u003cp\u003eThe obtained data were transferred to the computer environment and analyzed using the SPSS v. 25.0 (SPSS, Inc., Chicago, IL) package program. Data were presented as mean, standard deviation, median, minimum, maximum, percentage, and number. The normality of the distribution of continuous variables was examined with the Shapiro-Wilk W test when the sample size was \u0026lt;\u0026thinsp;50, and the Kolmogorov-Smirnov test when the sample size was \u0026ge;\u0026thinsp;50. In comparisons between two independent groups, the independent-samples t-test was used if the normal distribution condition was met, and the Mann-Whitney U test was used otherwise. In 2x2 comparisons between categorical variables, the Pearson chi-square test was conducted if the expected value was \u0026gt;\u0026thinsp;5, the chi-square Yates test if the expected value was between 3 and 5, and the Fisher\u0026rsquo;s exact test if the expected value was \u0026lt;\u0026thinsp;3. For comparisons between categorical variables larger than 2x2, the Pearson chi-square test was employed when the expected value was \u0026gt;\u0026thinsp;5, and the Fisher-Freeman-Halton test was used when the expected value was \u0026lt;\u0026thinsp;5. P\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e \u003c/div\u003e"},{"header":"3. Results","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003e3.1. Patient populations and characteristics\u003c/h2\u003e \u003cp\u003eTreatment was applied to 178 patients who presented to the emergency department; however, 28 patients were excluded from the study since they did not visit the emergency department at the 48th hour. As a result, 150 patients were included in the sample. The demographic and characteristic features of the patients are given in Table-1. Male patients constituted 65.3% of the patients in Group D and 54.7% of those in Group DM. The mean age was 34.89\u0026thinsp;\u0026plusmn;\u0026thinsp;10.92 years for Group D and 40.84\u0026thinsp;\u0026plusmn;\u0026thinsp;10.93 years for Group DM. In Group D, the mean systolic blood pressure was 129.35\u0026thinsp;\u0026plusmn;\u0026thinsp;17.36 mmHg, the mean diastolic blood pressure was 81.89\u0026thinsp;\u0026plusmn;\u0026thinsp;12.49 mmHg, the mean respiratory rate was 15.2\u0026thinsp;\u0026plusmn;\u0026thinsp;1.79 per minute, the mean oxygen saturation was 94.85\u0026thinsp;\u0026plusmn;\u0026thinsp;2%, and the mean pulse was 89.64\u0026thinsp;\u0026plusmn;\u0026thinsp;16.95 per minute, while for Group DM, these values were determined to be 126.73\u0026thinsp;\u0026plusmn;\u0026thinsp;16.66 mmHg, 76.17\u0026thinsp;\u0026plusmn;\u0026thinsp;12.11 mmHg, 17.24\u0026thinsp;\u0026plusmn;\u0026thinsp;9.65 per minute, 94.69\u0026thinsp;\u0026plusmn;\u0026thinsp;2.56%, and 82.28\u0026thinsp;\u0026plusmn;\u0026thinsp;12.92 beats per minute, respectively.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003e3.2. Comparison of groups\u003c/h2\u003e \u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eThe pain sensations of patients who presented to the emergency department with complaints of non-traumatic low back pain were evaluated using the VAS. The mean baseline (minute 0) VAS scores of Group D and Group DM were 8.12\u0026thinsp;\u0026plusmn;\u0026thinsp;1.59 and 7.49\u0026thinsp;\u0026plusmn;\u0026thinsp;1.81 cm, respectively. Accordingly, the VAS score of the patients in Group D was significantly higher than that of those in Group DM at baseline (p\u0026thinsp;=\u0026thinsp;0.032). The VAS scores evaluated during the follow-up period after starting treatment exhibited a decrease in both groups (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05 in all follow-up evaluations). The mean VAS score evaluated 48 hours after treatment was 1.69\u0026thinsp;\u0026plusmn;\u0026thinsp;1.71 cm for Group DM and 4.13\u0026thinsp;\u0026plusmn;\u0026thinsp;2.27 cm for Group D, indicating a statistically significant difference between the groups (p\u0026thinsp;=\u0026thinsp;0.000). The mean decrease from the baseline to hour 48 was 3.99 units for Group D versus 5.8 units for Group DM (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). This suggested that dexketoprofen\u0026thinsp;+\u0026thinsp;methylprednisolone had greater analgesic efficacy. Figure\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e presents the comparison of the VAS scores of the groups according to the follow-up evaluation time.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDemographic and clinical characteristics of the groups\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGroup D\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eGroup DM\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eAge (years), (mean, SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e34.89\u0026thinsp;\u0026plusmn;\u0026thinsp;10.92\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e40.84\u0026thinsp;\u0026plusmn;\u0026thinsp;10.93\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eGender\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e49 (65.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e41 (54.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.182\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e26 (34.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e34 (45.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eChronic disease history\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePresent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12 (16%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.132\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAbsent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e69 (92%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e63 (84%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eStraight leg raise test\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePositive\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22 (29.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e38 (50.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.008\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNegative\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e53 (70.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e37 (49.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eUrinary incontinence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePresent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (1.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.316\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAbsent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e74 (98.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eSystolic blood pressure (mmHg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e129.35\u0026thinsp;\u0026plusmn;\u0026thinsp;17.36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e126.73\u0026thinsp;\u0026plusmn;\u0026thinsp;16.66\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.588\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eDiastolic blood pressure (mmHg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e81.89\u0026thinsp;\u0026plusmn;\u0026thinsp;12.49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e76.17\u0026thinsp;\u0026plusmn;\u0026thinsp;12.11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.007\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eRespiratory rate (/min)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15.2\u0026thinsp;\u0026plusmn;\u0026thinsp;1.79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e17.24\u0026thinsp;\u0026plusmn;\u0026thinsp;9.65\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.012\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eOxygen saturation (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e94.85\u0026thinsp;\u0026plusmn;\u0026thinsp;2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e94.69\u0026thinsp;\u0026plusmn;\u0026thinsp;2.56\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.691\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003ePulse (beat/min)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e89.64\u0026thinsp;\u0026plusmn;\u0026thinsp;16.95\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e82.28\u0026thinsp;\u0026plusmn;\u0026thinsp;12.92\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.011\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eGroup D: dexketoprofen-administered group; Group DM: dexketoprofen\u0026thinsp;+\u0026thinsp;methylprednisolone-administered group; SD: standard deviation\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eEvaluation of the VAS scores of the groups\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVAS (cm)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGroup D\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGroup DM\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBaseline (minute 0), median (min-max)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (4\u0026ndash;10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (2\u0026ndash;10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.032\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMinute 15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (1\u0026ndash;10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (0\u0026ndash;10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMinute 30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (0\u0026ndash;10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (0\u0026ndash;10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMinute 60\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (0\u0026ndash;10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (0\u0026ndash;9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHour 48\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (0\u0026ndash;10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (0\u0026ndash;8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003eVAS: Visual Analog Scale; Group D: dexketoprofen-administered group; Group DM: dexketoprofen\u0026thinsp;+\u0026thinsp;methylprednisolone-administered group; min: minimum; max: maximum\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe patients\u0026rsquo; ODI scores were determined at the time of presentation to the hospital (minute 0) and 48 hours after treatment. According to the data obtained, the mean baseline ODI score of Group DM was 43.95\u0026thinsp;\u0026plusmn;\u0026thinsp;22.09, which was higher than that of Group D, but it did not result in a statistically significant difference (p\u0026thinsp;=\u0026thinsp;0.514). According to the re-evaluation made 48 hours after the application of the allocated treatments, there was a decrease in the ODI scores of both groups (mean ODI score: 33.27\u0026thinsp;\u0026plusmn;\u0026thinsp;23.31 for Group D and 18.67\u0026thinsp;\u0026plusmn;\u0026thinsp;14.44 for Group DM), and the efficacy of the treatments increased. The decrease in the ODI score was greater in Group DM than in Group D, and this was at a statistically significant level (p\u0026thinsp;=\u0026thinsp;0.000) (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). The comparison of the ODI scores of the groups according to the evaluation time is given in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eEvaluation of the ODI scores of the groups\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eODI score (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGroup D\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGroup DM\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBaseline (minute 0), median (min-max)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40 (4\u0026ndash;92)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e40 (6-100)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.514\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHour 48\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e31 (0-116)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16 (0\u0026ndash;72)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003eVAS: Visual Analog Scale; Group D: dexketoprofen-administered group; Group DM: dexketoprofen\u0026thinsp;+\u0026thinsp;methylprednisolone-administered group; min: minimum; max: maximum\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eIt is known that NSAIDs are the first pharmacological agents to be preferred in the treatment of low back pain, while corticosteroids alone are not useful for this purpose. Our study is one of the first investigations on the analgesic and functional effects of NSAIDs and corticosteroids in combination therapy. Our results showed that NSAIDs had an analgesic effect on low back pain, but when used in combination with corticosteroids, the pain intensity of the patients further decreased.\u003c/p\u003e \u003cp\u003ePharmacological treatments are administered to patients who have a history of low back pain, those who refrain from non-pharmacological approaches, or those who are at risk of developing serious complications related to low back pain. As per the recommendations of the American Medical Association, it is advised to initiate NSAIDs and muscle relaxants as a first step in pharmacological therapy.\u003csup\u003e[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]\u003c/sup\u003e In a systematic review of patients treated for low back pain, the analgesic efficacy of pharmacological agents in the NSAID group was evaluated in patients aged 18\u0026ndash;65 years.\u003csup\u003e[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]\u003c/sup\u003e Other studies including patients suffering from acute and chronic low back pain without a specific cause evaluated analgesic effect and disability status after oral piroxicam treatment, \u003csup\u003e[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/sup\u003e analgesic effect and functional capacity after intramuscular tenoxicam injection, \u003csup\u003e[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]\u003c/sup\u003e and the analgesic effect after intravascular diclofenac treatment.\u003csup\u003e[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]\u003c/sup\u003e Systematic evaluations have determined that the use of NSAIDs in both acute and chronic low back pain provides adequate analgesia and significantly improves physical capability.\u003csup\u003e[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eMany studies have been conducted on the use of dexketoprofen for analgesia. The analgesic effects of paracetamol and ibuprofen, \u003csup\u003e[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]\u003c/sup\u003e diclofenac sodium, \u003csup\u003e[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]\u003c/sup\u003e placebo, \u003csup\u003e[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]\u003c/sup\u003e and morphine \u003csup\u003e[\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]\u003c/sup\u003e have been compared in low back pain. These studies have found that dexketoprofen exhibited either a greater analgesic effect \u003csup\u003e[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]\u003c/sup\u003e or had no difference \u003csup\u003e[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]\u003c/sup\u003e when compared to other agents. In our study, the use of dexketoprofen alone in low back pain had analgesic efficacy, similar to previous studies.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eCorticosteroids are another type of pharmacological agent used in individuals with acute or chronic low back pain. The analgesic effect of corticosteroids has also been investigated. However, there are only a limited number of studies comparing their analgesic effects to those of other agents for low back pain. In a study investigating the efficacy of oral prednisolone treatment alone in low back pain, no significant difference was found compared to the control group. \u003csup\u003e[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]\u003c/sup\u003e In another study, intramuscular methylprednisolone and placebo groups were compared in patients who presented to the emergency department with low back pain, and methylprednisolone was found to have an analgesic effect. \u003csup\u003e[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]\u003c/sup\u003e We observed significant reductions in VAS scores at minutes 15, 30, and 60 and hour 48 compared to the initial measurement at minute 0. Additionally, the patients with high levels of baseline disability had a significant decrease in their ODI scores after treatment.\u003c/p\u003e\u003cp\u003eAlthough the research in the literature has proven that the use of corticosteroids alone is not useful for low back pain, there are a few studies showing its benefits. The functionality and analgesic effects of intramuscular methylprednisolone treatment were investigated in patients who presented to the emergency department with low back pain and had a positive straight leg raise test. It was observed that the additional analgesic medication requirements and pain complaints of the corticosteroid-treated group decreased compared to the control group.\u003csup\u003e[\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]\u003c/sup\u003e In another study, the benefits of oral steroid treatment for the relief of pain caused by sciatic injury were investigated. In the comparison performed between the control group and patients receiving oral steroid treatment, it was observed that the ODI scores decreased rapidly and functionality improved in the latter during the follow-up period. It was also determined that the patients treated with methylprednisolone have less need for additional analgesic medication.\u003csup\u003e[\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]\u003c/sup\u003e In the current study, we found a greater level of decrease in the ODI scores of patients who were administered dexketoprofen\u0026thinsp;+\u0026thinsp;methylprednisolone than in those who received dexketoprofen alone.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eThe literature also contains studies investigating the combinations of NSAIDs and steroids for different analgesic effects. It has been determined that a steroid combination was more effective for analgesia in patients with plantar fasciitis.\u003csup\u003e[\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]\u003c/sup\u003e In a study comparing the efficacy of NSAIDs and prednisolone in the management of postoperative pain in patients undergoing tonsillectomy, the use of steroids was shown to increase postoperative comfort. \u003csup\u003e[\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]\u003c/sup\u003e In the current study, it was determined that the analgesic effect of steroid use together with NSAIDs was greater than in previous studies.\u003c/p\u003e"},{"header":"5. Limitations","content":"\u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eThere are some limitations to our study, with the most important being its single-center design and small sample size. Another limitation is that pain intensity was determined according to patient accounts, making it a subjective evaluation. Furthermore, our study is limited by the absence of a placebo group and the brief duration in which we assessed the efficacy of symptomatic treatment.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e"},{"header":"6. Conclusion","content":"\u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eThis study demonstrated that dexketoprofen had analgesic activity and reduced disability in the treatment of patients who present to the emergency department due to non-traumatic low back pain. When used in combination with methylprednisolone, dexketoprofen exhibited greater analgesic efficacy and resulted in the faster regression of disability. Therefore, it is concluded that the combined use of NSAIDs and steroids yields a greater analgesic effect in the management of patients who present to the emergency department with non-traumatic low back pain.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eEthics approval and consent to participate:\u0026nbsp;This study was approved by\u0026nbsp;Clinical Research Ethics Committee of the Atat\u0026uuml;rk University Faculty of Medicine (date: June 24, 2021, decision number 286). Patients were accepted into the study after obtaining informed consent from them or their relatives based on voluntariness. The study protocol followed the tenets of the Declaration of Helsinki.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical trial number:\u003c/strong\u003e Not applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u003c/strong\u003e Not applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e This study was financially supported by the Scientific Research Projects (BAP) Unit of Atat\u0026uuml;rk University with the project code TTU-2021-9373.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of Interest:\u0026nbsp;\u003c/strong\u003eThe authors have no conflict of interest to declare.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eMurray CJ, Lopez AD, Organization WH. The global burden of disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020: summary: World Health Organization; 1996.\u003c/li\u003e\n\u003cli\u003eHoy D, Brooks P, Blyth F, Buchbinder R, rheumatology BprC. The epidemiology of low back pain. 2010;24(6):769-81.\u003c/li\u003e\n\u003cli\u003eLopez AD. Global burden of disease and risk factors. 2006.\u003c/li\u003e\n\u003cli\u003eUrits I, Burshtein A, Sharma M, Testa L, Gold PA, Orhurhu V, et al. Low Back Pain, a Comprehensive Review: Pathophysiology, Diagnosis, and Treatment. Current pain and headache reports. 2019;23(3):23.\u003c/li\u003e\n\u003cli\u003eChenot JF, Greitemann B, Kladny B, Petzke F, Pfingsten M, Schorr SG. Non- Specific Low Back Pain. Deutsches Arzteblatt international. 2017;114(51-52):883-90.\u003c/li\u003e\n\u003cli\u003eKnezevic NN, Candido KD, Vlaeyen JWS, Van Zundert J, Cohen SP. Low back pain. The Lancet. 2021;398(10294):78-92.\u003c/li\u003e\n\u003cli\u003eChou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, et al. Nonpharmacologic therapies for low back pain: a systematic review for an American College of Physicians clinical practice guideline. Annals of internal medicine. 2017;166(7):493-505.\u003c/li\u003e\n\u003cli\u003eFrench SD, Cameron M, Walker BF, Reggars JW, Esterman A. A Cochrane review of superficial heat or cold for low back pain. 2006;31(9):998-1006.\u003c/li\u003e\n\u003cli\u003eKoes BW, Backes D, Bindels PJE. Pharmacotherapy for chronic non-specific low back pain: current and future options. Expert opinion on pharmacotherapy. 2018;19(6):537-45.\u003c/li\u003e\n\u003cli\u003eFrench SD, Nielsen M, Hall L, Nicolson PJ, van Tulder M, Bennell KL, et al. Essential key messages about diagnosis, imaging, and self-care for people with low back pain: a modified Delphi study of consumer and expert opinions. 2019;160(12):2787-97.\u003c/li\u003e\n\u003cli\u003eKarjalainen K, Malmivaara A, Pohjolainen T, Hurri H, Mutanen P, Rissanen P, et al. Mini-intervention for subacute low back pain: a randomized controlled trial. LWW; 2003.\u003c/li\u003e\n\u003cli\u003eLuomajoki HA, Beltran MBB, Careddu S, Bauer CM. Effectiveness of movement control exercise on patients with non-specific low back pain and movement control impairment: a systematic review and meta-analysis. Musculoskeletal Science Practice. 2018;36:1-11.\u003c/li\u003e\n\u003cli\u003eChou R, Qaseem A, Snow V, Casey D, Cross JT, Jr., Shekelle P, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Annals of internal medicine. 2007;147(7):478-91.\u003c/li\u003e\n\u003cli\u003ede Campos, Folly T. Low back pain and sciatica in over 16s: assessment and management NICE Guideline [NG59]. 2017;63(2):120.\u003c/li\u003e\n\u003cli\u003eMuehlbacher M, Nickel MK, Kettler C, Tritt K, Lahmann C, Leiberich PK, et al. Topiramate in treatment of patients with chronic low back pain: a randomized, double- blind, placebo-controlled study. Clin J Pain. 2006;22(6):526-31.\u003c/li\u003e\n\u003cli\u003eQaseem A, Wilt TJ, McLean RM, Forciea MA. Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of Physicians. Clinical Guidelines Committee of the American College of Physicians. 2017;166(7):514-30.\u003c/li\u003e\n\u003cli\u003evan Tulder MW, Scholten RJ, Koes BW, Deyo RA. Nonsteroidal anti- inflammatory drugs for low back pain: a systematic review within the framework of the Cochrane Collaboration Back Review Group. Spine (Phila Pa 1976). 2000;25(19):2501- 13.\u003c/li\u003e\n\u003cli\u003eWeber H, Holme I, Amlie E. The natural course of acute sciatica with nerve root symptoms in a double-blind placebo-controlled trial evaluating the effect of piroxicam. Spine (Phila Pa 1976). 1993;18(11):1433-8.\u003c/li\u003e\n\u003cli\u003eSzpalski M, Hayez JP. Objective functional assessment of the efficacy of tenoxicam in the treatment of acute low back pain. A double-blind placebo-controlled study. British journal of rheumatology. 1994;33(1):74-8.\u003c/li\u003e\n\u003cli\u003eBabej-D\u0026ouml;lle R, Freytag S, Eckmeyer J, Zerle G, Schinzel S, Schmeider G, et al. Parenteral dipyrone versus diclofenac and placebo in patients with acute lumbago or sciatic pain: randomized observer-blind multicenter study. International journal of clinical pharmacology and therapeutics. 1994;32(4):204-9.\u003c/li\u003e\n\u003cli\u003eDogan C, Yilmaz A, Ozen M, Seyit M, Oskay A, Kemanci A, et al. Comparative evaluation of the effectiveness of intravenous paracetamol, dexketoprofen and ibuprofen in acute low back pain. The American Journal of Emergency Medicine. 2022;56:223-7.\u003c/li\u003e\n\u003cli\u003eBrzeziński K, Wordliczek J. Comparison of the efficacy of dexketoprofen and diclofenac in treatment of non-specific low back pain. Annals of agricultural and environmental medicine : AAEM. 2013;Spec no. 1:52-6.\u003c/li\u003e\n\u003cli\u003eRoelofs PD, Deyo RA, Koes BW, Scholten RJ, van Tulder MW. Non-steroidal anti-inflammatory drugs for low back pain. The Cochrane database of systematic reviews. 2008(1):Cd000396.\u003c/li\u003e\n\u003cli\u003eEken C, Serinken M, Elicabuk H, Uyanik E, Erdal M. Intravenous paracetamol versus dexketoprofen versus morphine in acute mechanical low back pain in the emergency department: a randomised double-blind controlled trial. Emergency medicine journal : EMJ. 2014;31(3):177-81\u003c/li\u003e\n\u003cli\u003eEskin B, Shih RD, Fiesseler FW, Walsh BW, Allegra JR, Silverman ME, et al. Prednisone for emergency department low back pain: a randomized controlled trial. The Journal of emergency medicine. 2014;47(1):65-70\u003c/li\u003e\n\u003cli\u003eHedeboe J, Buhl M, Ramsing P. Effects of using dexamethasone and placebo in the treatment of prolapsed lumbar disc. Acta neurologica Scandinavica. 1982;65(1):6- 10.\u003c/li\u003e\n\u003cli\u003eFriedman BW, Holden L, Esses D, Bijur PE, Choi HK, Solorzano C, et al. Parenteral corticosteroids for Emergency Department patients with non-radicular low back pain. The Journal of emergency medicine. 2006;31(4):365-70.\u003c/li\u003e\n\u003cli\u003eFriedman BW, Esses D, Solorzano C, Choi HK, Cole M, Davitt M, et al. A randomized placebo-controlled trial of single-dose IM corticosteroid for radicular low back pain. Spine (Phila Pa 1976). 2008;33(18):E624-9.\u003c/li\u003e\n\u003cli\u003eHolve RL, Barkan H. Oral steroids in initial treatment of acute sciatica. Journal of the American Board of Family Medicine : JABFM. 2008;21(5):469-74.\u003c/li\u003e\n\u003cli\u003eAkram MR, Yousaf MN, Waseem M, Chaudhary FS. Comparison of mean pain score of oral non-steroidal anti-inflammatory agents and locally injectable steroid for the treatment of plantar fasciitis. JPMA The Journal of the Pakistan Medical Association. 2022;72(2):231-5\u003c/li\u003e\n\u003cli\u003eAveline C, Le Hetet H, Le Roux A, Bonnet F. A survey of the administration of prednisolone versus ibuprofen analgesic protocols after ambulatory tonsillectomy. Anaesthesia, critical care \u0026amp; pain medicine. 2015;34(5):281-7.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-emergency-medicine","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"emmd","sideBox":"Learn more about [BMC Emergency Medicine](http://bmcemergmed.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/emmd","title":"BMC Emergency Medicine","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Low back pain, Dexketoprofen, Methylprednisolone, Visual Analog Scale, Oswestry Disability Index","lastPublishedDoi":"10.21203/rs.3.rs-6243015/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6243015/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground: 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).\u003c/p\u003e\n\u003cp\u003eMethods: 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.\u003c/p\u003e\n\u003cp\u003eResults: The VAS scores decreased in both groups at all follow-up evaluations performed throughout the treatment (p\u0026lt;0.05). The mean VAS score evaluated 48 hours after treatment was 1.69±1.71 cm in Group DM and 4.13±2.27 cm in Group D (p=0.000). The decrease in the ODI score was greater in Group DM than in Group D (p=0.000).\u003c/p\u003e\n\u003cp\u003eConclusion: Dexketoprofen showed analgesic efficacy in the treatment of non-traumatic low back pain and decreased disability. When combined with methylprednisolone, dexketoprofen treatment exhibit a greater analgesic effect and further reduced disability.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration: \u003c/strong\u003eCurrent Controlled Trials NCT06932367 (Retrospectively registered)\u003c/p\u003e","manuscriptTitle":"A Comparative Study on the Efficacy of Dexketoprofen and Methylprednisolone in the Treatment of Acute Low Back Pain","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-07 03:30:54","doi":"10.21203/rs.3.rs-6243015/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-05-19T04:33:30+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-05-18T12:09:36+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-05-15T14:08:32+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-05-01T18:55:58+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"192888645625613326083389170688720992611","date":"2025-04-26T17:40:34+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"291784379994550784063299887903854347847","date":"2025-04-25T05:10:38+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"192917474705562740134469717356419242609","date":"2025-04-24T17:19:43+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"176996110338868530284089015855155423554","date":"2025-04-24T16:56:18+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-04-24T16:46:04+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-04-18T07:49:35+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-04-18T07:46:35+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-04-17T07:18:59+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Emergency Medicine","date":"2025-04-17T07:17:50+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-emergency-medicine","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"emmd","sideBox":"Learn more about [BMC Emergency Medicine](http://bmcemergmed.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/emmd","title":"BMC Emergency Medicine","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"f0b16f1b-e4e1-4411-ba1c-02c127b40384","owner":[],"postedDate":"May 7th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-08-11T16:09:26+00:00","versionOfRecord":{"articleIdentity":"rs-6243015","link":"https://doi.org/10.1186/s12873-025-01276-y","journal":{"identity":"bmc-emergency-medicine","isVorOnly":false,"title":"BMC Emergency Medicine"},"publishedOn":"2025-08-05 15:58:08","publishedOnDateReadable":"August 5th, 2025"},"versionCreatedAt":"2025-05-07 03:30:54","video":"","vorDoi":"10.1186/s12873-025-01276-y","vorDoiUrl":"https://doi.org/10.1186/s12873-025-01276-y","workflowStages":[]},"version":"v1","identity":"rs-6243015","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6243015","identity":"rs-6243015","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}