Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:19 AM
Study NCT ID:
NCT07475793
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Ultrasound vs Fluoroscopy Guided Genicular Nerve Radiofrequency Ablation for Chronic Knee Osteoarthritis: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of Block', 'timeFrame': 'Post procedure 2 weeks, then follow up after 2, 4 and 6 months.', 'description': 'Block will be considered effective if decrease in pain score from baseline is \\>50% at six months. And this will measure by using the 11-point Numeric Rating Scale (NRS) where 0 = no pain and 10 = worst imaginable pain.'}], 'secondaryOutcomes': [{'measure': 'Functional Improvement after block', 'timeFrame': '6 months', 'description': 'Functional improvement after genicular nerve block is describe as \\> 20 % decrease in KOOS PS score from baseline at six months. Functional condition will be assessed using the Knee injury and osteoarthritis outcomes score-Physical function short form (KOOS-PS) tool. Minimum score is 0 and maximum is 20 which will then be converted into ratio from 0 to 100%, 0 means no functional impairment and 100 means maximum functional impairment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective randomized control trial is to provide continued pain relief, classically long-lasting 3 to12 months, and enhanced function in patients following: both gender; male and female, age group; \\>50yr, healthy volunteers along with Radiographic diagnosis of knee OA with KL grade 3 and 4 in addition of Chronic knee pain ≥ 6 months and patients with ≥50% decrease in pain strength after diagnostic genicular nerve block. The main question it aims to answer is:\n\nIs ultrasound-guided genicular nerve RFA more efficient in lowering pain intensity at six months contrasted with fluoroscopic guided method in patients with chronic knee osteoarthritis? Researchers will compare Group A (Fluoroscopic) to Group B (Ultrasound) to see comparison in efficiency of ultrasound guided against fluoroscopic guided genicular nerves block for decrease in pain intensity and functional improvement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both gender patients of age more than 50 years.\n* Radiographic diagnosis of knee OA with KL level 3 and 4.\n* Chronic knee pain for more than 6 months\n* Patients with more than 50% reduction in pain intensity after diagnostic genicular nerve block\n\nExclusion Criteria:\n\n* Lack of consent\n* surgery of knee\n* Patient with BMI more than 40kg/m2\n* Intra-articular steroid injection or hyaluronic acid in last 3 months\n* Localized infection at procedure site or knee.\n* Patient unable to communicate properly (Severe psychiatric illness, severe dementia and cognitive impairment).\n* Patients have moderate to severe low back pain (NRS ≥5)'}, 'identificationModule': {'nctId': 'NCT07475793', 'briefTitle': 'Efficacy of Ultrasound vs Fluoroscopy Guided Genicular Nerve Radiofrequency Ablation for Chronic Knee Osteoarthritis: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Efficacy of Ultrasound vs Fluoroscopy Guided Genicular Nerve Radiofrequency Ablation for Chronic Knee Osteoarthritis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2026-12711-40401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Intervention group in which genicular nerves radiofrequency ablation will be done with the help ultrasound guidance.', 'interventionNames': ['Procedure: Ultrasound Guided']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Control group in which genicular nerves radiofrequency ablation will be done with the help of fluoroscopic guidance.', 'interventionNames': ['Procedure: Fluoroscope Guided']}], 'interventions': [{'name': 'Ultrasound Guided', 'type': 'PROCEDURE', 'description': 'Genicular nerves radiofrequency ablation will be done with the help of ultrasound guidance.', 'armGroupLabels': ['Group B']}, {'name': 'Fluoroscope Guided', 'type': 'PROCEDURE', 'description': 'Control group in which genicular nerves radiofrequency ablation will be done with the help of fluoroscopic guidance.', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ali Sarfraz Siddiqui, MBBS-FCPS', 'role': 'CONTACT', 'email': 'sarfraz.siddiqui@aku.edu', 'phone': '+92 021-38104397', 'phoneExt': '4397'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ali Sarfraz Siddiqui', 'investigatorAffiliation': 'Aga Khan University'}}}}