Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 7:11 PM
Study NCT ID:
NCT06932367
Status:
COMPLETED
Last Update Posted:
2025-04-17
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Dexketoprofen And Methylprednisolone in the Acute Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C118296', 'term': 'dexketoprofen trometamol'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-15', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS) score', 'timeFrame': '48 hours', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '48 hours', 'description': '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.\n\nWhile interpreting the ODI score, the the scores are considered as:\n\n0% 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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low back pain', 'Dexketoprofen', 'Methylprednisolone', 'Visual Analog Scale', 'Oswestry Disability Index'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '40765043', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged over 18 and under 65 years.\n* The patients who presented to the emergency department with acute non-traumatic low back pain.\n* Voluntarily agreed to participate in the study.\n\nExclusion Criteria:\n\n* The patients who had used analgesics within the last six hours;\n* Who has neurological deficits, cardiac or chest pain, liver, kidney, cardiac or pulmonary failure, chronic pain,\n* 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;\n* 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;\n* The patients who were illiterate.'}, 'identificationModule': {'nctId': 'NCT06932367', 'acronym': 'Pain', 'briefTitle': 'The Efficacy of Dexketoprofen And Methylprednisolone in the Acute Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Efficacy of Dexketoprofen And Methylprednisolone in the Acute Low Back Pain', 'orgStudyIdInfo': {'id': 'B.30.2.ATA0.01.00/286'}, 'secondaryIdInfos': [{'id': 'TTU-2021-9373', 'type': 'OTHER_GRANT', 'domain': 'Ataturk University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': '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', 'interventionNames': ['Drug: Dexketoprofen (KETAVEL 50 mg/2 ml)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': '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.', 'interventionNames': ['Combination Product: Methylprednisolone (Corticosteroid)']}], 'interventions': [{'name': 'Dexketoprofen (KETAVEL 50 mg/2 ml)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Group 1']}, {'name': 'Methylprednisolone (Corticosteroid)', 'type': 'COMBINATION_PRODUCT', 'description': '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.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25100', 'city': 'Erzurum', 'state': 'Yakutiye', 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'overallOfficials': [{'name': 'Mehmet Meral Ataturk University Medical Faculty, Emergency Department, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ataturk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data that support the findings of this study are available from the corresponding author, upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ali Gur', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof.', 'investigatorFullName': 'Ali Gur', 'investigatorAffiliation': 'Ataturk University'}}}}