Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT07174167
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2025-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genicular Nerve Block in Chronic Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011318', 'term': 'Prilocaine'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-23', 'studyFirstSubmitDate': '2025-09-02', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Ultrasound evaluation', 'timeFrame': 'baseline', 'description': 'Ultrasound measurements were taken to assess patellofemoral cartilage thickness and quadriceps muscle thickness'}], 'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'at baseline, 1 week, and 1 month after treatment', 'description': 'Visual Analog Scale (VAS): The VAS assesses pain intensity on a 10-centimeter scale. Patients indicate their pain levels using two verbal descriptors at the end of each scale.'}], 'secondaryOutcomes': [{'measure': 'Functional status using WOMAC', 'timeFrame': 'baseline, 1 week, and 1 month after treatment', 'description': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire assessed pain and disability.'}, {'measure': 'Functional status using 40-Meter Fast Walking Test', 'timeFrame': 'at baseline, 1 week, and 1 month after treatment', 'description': '40-Meter Fast Walking Test: This test involved a designated 10-meter walking track. Patients walked at their maximum pace for four laps. No warm-up was conducted, and the time spent turning at the lines was excluded from the calculation'}, {'measure': 'Pressure Pain Threshold (PPT)', 'timeFrame': 'baseline, 1 week, and 1 month after treatment', 'description': 'Pressure Pain Threshold (PPT): The Commander Algometer (JTECH Medical, Utah, USA) was utilized to measure PPT at both the medial and lateral sides of the patella. The probe tip of the algometer was applied perpendicularly to the skin, and pressure was gradually increased. Patients indicated when they first experienced discomfort, at which point the measurement was recorded. This procedure was repeated three times, and the average value was noted.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['genicular nerve block', 'knee osteoarthritis', 'pain', 'disability', 'gonarthrosis'], 'conditions': ['Gonarthrosis; Primary', 'Genicular Nerve Block', 'Gonarthritis']}, 'referencesModule': {'references': [{'pmid': '39901967', 'type': 'BACKGROUND', 'citation': 'Li W, Xu F, Chen F, Cao L, Bao X. Effect of Genicular Nerve Block (GNB) on Pain in Lesions of the Knee Joint: A Meta-Analysis of Randomized Controlled Trials. J Pain Res. 2025 Jan 30;18:511-522. doi: 10.2147/JPR.S503937. eCollection 2025.'}, {'pmid': '30921977', 'type': 'BACKGROUND', 'citation': 'Kim DH, Lee MS, Lee S, Yoon SH, Shin JW, Choi SS. A Prospective Randomized Comparison of the Efficacy of Ultrasound- vs Fluoroscopy-Guided Genicular Nerve Block for Chronic Knee Osteoarthritis. Pain Physician. 2019 Mar;22(2):139-146.'}, {'pmid': '29357330', 'type': 'BACKGROUND', 'citation': 'Kim DH, Choi SS, Yoon SH, Lee SH, Seo DK, Lee IG, Choi WJ, Shin JW. Ultrasound-Guided Genicular Nerve Block for Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial of Local Anesthetic Alone or in Combination with Corticosteroid. Pain Physician. 2018 Jan;21(1):41-52.'}, {'pmid': '36369781', 'type': 'BACKGROUND', 'citation': 'Shanahan EM, Robinson L, Lyne S, Woodman R, Cai F, Dissanayake K, Paddick K, Cheung G, Voyvodic F. Genicular Nerve Block for Pain Management in Patients With Knee Osteoarthritis: A Randomized Placebo-Controlled Trial. Arthritis Rheumatol. 2023 Feb;75(2):201-209. doi: 10.1002/art.42384. Epub 2022 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate whether genicular nerve block (GNB) is effective in reducing pain in patients with knee osteoarthritis. It will also assess the comparative efficacy of different injection protocols.\n\nThe main questions it aims to answer are:\n\nDoes genicular nerve block with corticosteroid and local anesthetic provide superior pain relief compared with local anesthetic alone or placebo?\n\nAre there differences in clinical outcomes between the three treatment groups?\n\nResearchers will compare three groups:\n\nGNB with corticosteroid plus local anesthetic\n\nGNB with local anesthetic alone\n\nSham procedure with saline (placebo control)\n\nParticipants will:\n\nReceive the assigned injection protocol in accordance with their group\n\nBe evaluated at baseline and scheduled follow-up visits for pain intensity and functional status\n\nReport their pain scores and functional limitations using standardized assessment tools'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age between 45 and 75\n* diagnosed with knee osteoarthritis (OA) according to the American College of Rheumatology (ACR) criteria\n* possessing a Kellgren-Lawrence radiological grade of 2-3\n\nExclusion Criteria:\n\n* any joint injection to the target knee in the past 3 months\n* physical therapy for the target knee within the last 3 months\n* previous knee surgery\n* inflammatory rheumatic diseases\n* active lumbar radiculopathy on the same side\n* neurological disorders (e.g., Alzheimer's or dementia)\n* uncontrolled cardiopulmonary diseases\n* pregnancy or lactation\n* obesity (body mass index \\[BMI\\] \\>35)\n* presence of a pacemaker\n* active malignancy"}, 'identificationModule': {'nctId': 'NCT07174167', 'acronym': 'GNB-KOA-RCT', 'briefTitle': 'Genicular Nerve Block in Chronic Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Haydarpasa Numune Training and Research Hospital'}, 'officialTitle': 'Effectiveness of Genicular Nerve Block on Pain and Disability in Chronic Knee Osteoarthritis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KAEK 2023/58'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'genicular nerve block with local anesthetic', 'description': 'Group 1 (GNB with local anesthetic only): Patients received a genicular nerve block (GNB) with 6 mL of 2% prilocaine and participated in a knee exercise program.', 'interventionNames': ['Drug: Genicular nerve block with prilocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'genicular nerve block with local anesthetic and corticosteroid', 'description': 'Group 2 (GNB with local anesthetic and corticosteroid): Patients received GNB with 5 mL of 2% prilocaine in combination with 1 mL/40 mg of triamcinolone and followed the same exercise regimen.', 'interventionNames': ['Drug: genicular nerve block with prilocaine and triamcinolone']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham injection with saline', 'description': 'Group 3 (Control group): Patients received a placebo injection (6 mL of 0.9% saline) with the knee exercise program.', 'interventionNames': ['Drug: Sham injection']}], 'interventions': [{'name': 'Genicular nerve block with prilocaine', 'type': 'DRUG', 'otherNames': ['group 1'], 'description': 'ultrasound guided genicular nerve block (GNB) injecting 6 mL of 2% prilocaine to the genicular nerves', 'armGroupLabels': ['genicular nerve block with local anesthetic']}, {'name': 'genicular nerve block with prilocaine and triamcinolone', 'type': 'DRUG', 'otherNames': ['group 2'], 'description': 'ultrasound guided genicular nerve block (GNB) injecting 5 mL of 2% prilocaine in combination with 1 mL/40 mg of triamcinolone to the genicular nerves', 'armGroupLabels': ['genicular nerve block with local anesthetic and corticosteroid']}, {'name': 'Sham injection', 'type': 'DRUG', 'otherNames': ['group 3'], 'description': 'placebo injection using 6 mL of 0.9% saline to knee region other than genicular nerves', 'armGroupLabels': ['sham injection with saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Haydarpasa Numune Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The study data are available with the researcher and can be provided to the relevant authorities if required.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haydarpasa Numune Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Berna Gunay, MD', 'investigatorAffiliation': 'Haydarpasa Numune Training and Research Hospital'}}}}