Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT05291793
Status:
COMPLETED
Last Update Posted:
2022-03-23
First Post:
2022-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Different Intra-articular Injections Primary Gonarthrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C032801', 'term': 'tenoxicam'}, {'id': 'D011208', 'term': 'Powders'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-01', 'size': 73006, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-03-19T03:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'patients were not aware of the ingredient of the injection they had received Care providers were not aware of the ingredient of injection during application'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Identical work scheme applied in 4 different centers by 4 Physicians. Both patient selection, randomization, and blind injection applications have been implemented in same order.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2022-02-25', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': '2 weeks prior to intra-articular injection', 'description': "Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)"}, {'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'at 2nd week following intra-articular injection', 'description': "Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)"}, {'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'at 4th week following intra-articular injection', 'description': "Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)"}, {'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'at 6th week following intra-articular injection', 'description': "Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)"}, {'measure': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC)', 'timeFrame': '2 weeks prior to intra-articular injection', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.'}, {'measure': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC)', 'timeFrame': 'at 2nd week following intra-articular injection', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.'}, {'measure': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC)', 'timeFrame': 'at 4th week following intra-articular injection', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.'}, {'measure': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC)', 'timeFrame': 'at 6th week following intra-articular injection', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gonarthrosis', 'Saline injection', 'intra-articular'], 'conditions': ['Gonarthrosis; Primary']}, 'referencesModule': {'references': [{'pmid': '29688920', 'type': 'BACKGROUND', 'citation': 'Jevsevar DS, Shores PB, Mullen K, Schulte DM, Brown GA, Cummins DS. Mixed Treatment Comparisons for Nonsurgical Treatment of Knee Osteoarthritis: A Network Meta-analysis. J Am Acad Orthop Surg. 2018 May 1;26(9):325-336. doi: 10.5435/JAAOS-D-17-00318.'}, {'pmid': '30676699', 'type': 'BACKGROUND', 'citation': 'Jayaram P, Kennedy DJ, Yeh P, Dragoo J. Chondrotoxic Effects of Local Anesthetics on Human Knee Articular Cartilage: A Systematic Review. PM R. 2019 Apr;11(4):379-400. doi: 10.1002/pmrj.12007. Epub 2019 Mar 15.'}, {'pmid': '30915209', 'type': 'BACKGROUND', 'citation': 'Busse P, Vater C, Stiehler M, Nowotny J, Kasten P, Bretschneider H, Goodman SB, Gelinsky M, Zwingenberger S. Cytotoxicity of drugs injected into joints in orthopaedics. Bone Joint Res. 2019 Mar 2;8(2):41-48. doi: 10.1302/2046-3758.82.BJR-2018-0099.R1. eCollection 2019 Feb.'}, {'pmid': '27402605', 'type': 'BACKGROUND', 'citation': 'Bellamy JL, Goff BJ, Sayeed SA. Economic Impact of Ketorolac vs Corticosteroid Intra-Articular Knee Injections for Osteoarthritis: A Randomized, Double-Blind, Prospective Study. J Arthroplasty. 2016 Sep;31(9 Suppl):293-7. doi: 10.1016/j.arth.2016.05.015. Epub 2016 May 18.'}]}, 'descriptionModule': {'briefSummary': 'Gonarthrosis is a frequent cause of knee pain and mostly related to altered function of the knee. Intra-articular injections are a valuable noninvasive medical treatment of choice for pain management and functional enhancement. This study aims to investigate the effects of intra-articular injections without local anesthesics which are well known to be chondrotoxic. For this purpose, functional data of the patients who received intra-articular injections have been collected and analyzed.', 'detailedDescription': "Intra-articular knee injections are commonly used treatment method. It is preferred to relieve the pain and functional limitation due to knee osteoarthritis. Studies have shown the benefit of intra-articular injections, including intra-articular sterile saline injection alone. In addition, studies have shown chondrotoxic effects of local anesthetics and corticosteroids such as triamcinolone. Local anesthetics are often added to the injection in intra-knee injections. Many previous studies stated that anesthetic agents were mixed with corticosteroid and NSAID intra-articular injections but not in this study. This creates confusion on which preparation is effective on pain and function. The aim of this study is to compare pain-reducing and function-improving effects of intra-articular injection with corticosteroids or NSAIDs, while avoiding local anesthetics whose chondrotoxic effects have been confirmed. In order to reveal the unmasked effect, an intra-articular saline injection group was introduced as a sham treatment. Thus, a study with a level of evidence 1 will make a significant contribution to the literature.\n\nPatients who applied to the outpatient clinic and who were diagnosed with primary gonarthrosis by clinical and radiographic examinations have been randomized to four different groups by closed-envelope method following taking the informed consent. Accordingly, nonsteroidal anti-inflammatory (NSAI) drugs have been prescribed to all diagnosed patients. Demographic data of the patients have been noted and randomized into four equal groups of thirty individuals each. Afterwards, the first group received NSAID treatment, the second group received intra-articular methylprednisolone, the third group received intraarticular tenoxicam, and the fourth group received intra-articular sterile saline injection. All eligible patients have been given one random envelope by the secretary, then proceeded to the injection room with envelopes closed. The orthopedic technician prepared the injection depending on the information inside the envelope then the syringe is covered with opaque plaster or foil. Then, an injection was applied by the physician blindly. The patients' visual analog score(VAS) pain form and WOMAC scores are collected in each follow-up. Following the data has been obtained by an independent data recorder, all data have been saved to the database and statistical results were analyzed. According to the posthoc power analysis, the number of patients can be revised for statistical power."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years old\n* Diagnosed as Osteoarthritis ( in weight-bearing standing Antero-Posterior and Lateral knee plain radiographs)\n\nExclusion Criteria:\n\n* Patients refuse to enroll in the study voluntarily\n* Patients refuse to give informed consent\n* Patients who have received physiotherapy and/or intraarticular injection in the last 6 months.\n* Patients who have used supporting brace treatment in the last 6 months\n* Patients did not attend routine follow-up visits.\n* Patients experienced any allergic reaction to the administered drug'}, 'identificationModule': {'nctId': 'NCT05291793', 'briefTitle': 'The Effect of Different Intra-articular Injections Primary Gonarthrosis', 'organization': {'class': 'OTHER', 'fullName': 'Nevsehir Haci Bektas Veli University'}, 'officialTitle': 'The Effect of Different Intra-articular Injections on Pain and Function in Primary Gonarthrosis', 'orgStudyIdInfo': {'id': '2100027722'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'NSAID group', 'description': 'Group 1, patients only received non-steroid anti-inflammatory oral and topical treatment for 3 weeks. (ibuprofen 2x800 mg (1600 mg daily), 1% nimesulide + 5%Lidocain (3 times a day))'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tenoxicam', 'description': 'Group 2, patients received intraarticular tenoxicam ( 20 mg) once.', 'interventionNames': ['Drug: Tenoxicam 20 Mg Powder for Solution for Injection Vial']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methylprednisolone', 'description': 'Group 3, patients received intraarticular methylprednisolone once(40mg).', 'interventionNames': ['Drug: Methylprednisolone']}, {'type': 'SHAM_COMPARATOR', 'label': 'Saline', 'description': 'Group 4, patients received an intraarticular sterile saline injection(4ml).', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Tenoxicam 20 Mg Powder for Solution for Injection Vial', 'type': 'DRUG', 'description': 'Tenoxicam 20 Mg Powder is mixed with dissolving solvent then administered intraarticularly', 'armGroupLabels': ['Tenoxicam']}, {'name': 'Methylprednisolone', 'type': 'DRUG', 'description': 'Methylprednisolone 40 Mg (suspension) administered intraarticularly', 'armGroupLabels': ['Methylprednisolone']}, {'name': 'Saline', 'type': 'DRUG', 'description': '2ml sterile saline administered intraarticularly', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Kozyatağı', 'country': 'Turkey (Türkiye)', 'facility': 'Acıbadem Kozyatağı Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kartal Lutfi Kırdar State Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Nevşehir', 'country': 'Turkey (Türkiye)', 'facility': 'Nevşehir State Hospital', 'geoPoint': {'lat': 38.625, 'lon': 34.71222}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Study Protocol will be available following the paper has been published.', 'ipdSharing': 'YES', 'description': 'Even recruitment has been closed this study is still on progress. We are willing the share all our available data for future studies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nevsehir Haci Bektas Veli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Orthopedics and Traumatolgy Specialist, Principal Investigator', 'investigatorFullName': 'Yiğit Umur Cırdı', 'investigatorAffiliation': 'Acibadem Kozyatagi Hospital'}}}}