Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-31 @ 7:34 PM
Study NCT ID:
NCT06641206
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-Articular Dexmedetomidine: A Treatment for Chronic Knee Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-11', 'studyFirstSubmitDate': '2024-10-11', 'studyFirstSubmitQcDate': '2024-10-11', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post-intra-articular Injection.', 'timeFrame': '7 months', 'description': 'Value of intra-articular Injection in Pain Reduction of chronic knee pain manifested by recurrence of pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Knee Pain']}, 'descriptionModule': {'briefSummary': 'Chronic knee osteoarthritis (KOA) is a painful condition with limited treatment options. Non-pharmacological approaches often fall short, leading to decreased quality of life. Ozone therapy, a simple and affordable treatment, has shown promise for pain relief. Dexmedetomidine (DEX), a sedative and analgesic, has been used successfully as an adjuvant to anesthesia and local anesthetics. Given its potential for pain management, exploring DEX as a treatment for KOA could offer a new and promising approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were not assigned for surgical intervention;\n* Patients were free of exclusion criteria\n\nExclusion Criteria:\n\n* Patients were assigned for surgical intervention;\n* Patients who had uncontrolled hypertension and/or diabetes mellitus;\n* Patients who had uncompensated cardiac, renal, or hepatic diseases;\n* Patients with coagulopathy, spinal deformity, allergy, or contraindication for the used drugs;\n* Patients who refused to sign the informed consent were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06641206', 'briefTitle': 'Intra-Articular Dexmedetomidine: A Treatment for Chronic Knee Pain', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Intra-articular Dexmedetomidine for Treatment of Chronic Knee Pain: A Prospective Case-Control Clinical Trial', 'orgStudyIdInfo': {'id': '36264PR843/9/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': "A group of Patients from Tanta University suffering from Chronic painful knee osteoarthritis who didn't receive medical treatment and progressed to have chronic pain with decreased physical function and poorer quality of life.", 'interventionNames': ['Drug: Triamcinolone Acetonide', 'Drug: Bupivacaine Hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': "A group of Patients from Tanta University suffering from Chronic painful knee osteoarthritis who didn't receive medical treatment and progressed to have chronic pain with decreased physical function and poorer quality of life.", 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Triamcinolone Acetonide', 'type': 'DRUG', 'description': '1 ml of triamcinolone acetonide was used to prepare a solution for knee injection for patients with Chronic Knee Pain', 'armGroupLabels': ['Group 1']}, {'name': 'Bupivacaine Hydrochloride', 'type': 'DRUG', 'description': '20mg of bupivacaine hydrochloride was used to prepare a solution for knee injection for patients with Chronic Knee Pain', 'armGroupLabels': ['Group 1']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine solution was prepared by mixing Dexmedetomidine in a dose of 3 µg/kg in 5-ml saline', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Tanta', 'state': 'El Gharbyia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ali El Deeb, Professor', 'role': 'CONTACT', 'email': 'b.checked88@gmail.com', 'phone': '01222800335', 'phoneExt': '+2'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of Anesthesia and Surgical ICU, Faculty of Medicine', 'investigatorFullName': 'Ahmed ElKashef', 'investigatorAffiliation': 'Tanta University'}}}}