Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-26 @ 12:36 AM
Study NCT ID:
NCT02436434
Status:
WITHDRAWN
Last Update Posted:
2016-12-01
First Post:
2015-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The effect is poor', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2015-05-01', 'studyFirstSubmitQcDate': '2015-05-01', 'lastUpdatePostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of pain on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.', 'timeFrame': 'Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.', 'description': 'Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in severity of symptoms and functional status on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.', 'timeFrame': 'Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.', 'description': 'Use the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to measure the symptoms and functional status before treatment and multiple time frame after treatment.'}, {'measure': 'Change from baseline of range of motion on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.', 'timeFrame': 'Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.', 'description': 'Use the goniometer to measure the ROM before treatment and multiple time frame after treatment.'}, {'measure': 'Change from baseline of strength on 4th, 8th,12th and 16th weeks after treatment.', 'timeFrame': 'Pre-treatment 4th, 8th,12th and 16th weeks after treatment.', 'description': 'Use the isokinetic machine to measure the ROM before treatment and multiple time frame after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pulsed radiofrequency, osteoarthritis'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '18211593', 'type': 'BACKGROUND', 'citation': 'Sluijter ME, Teixeira A, Serra V, Balogh S, Schianchi P. Intra-articular application of pulsed radiofrequency for arthrogenic pain--report of six cases. Pain Pract. 2008 Jan-Feb;8(1):57-61. doi: 10.1111/j.1533-2500.2007.00172.x. No abstract available.'}, {'pmid': '25422652', 'type': 'BACKGROUND', 'citation': 'Rahimzadeh P, Imani F, Faiz SH, Entezary SR, Nasiri AA, Ziaeefard M. Investigation the efficacy of intra-articular prolotherapy with erythropoietin and dextrose and intra-articular pulsed radiofrequency on pain level reduction and range of motion improvement in primary osteoarthritis of knee. J Res Med Sci. 2014 Aug;19(8):696-702.'}, {'pmid': '23942592', 'type': 'BACKGROUND', 'citation': 'Masala S, Fiori R, Raguso M, Morini M, Calabria E, Simonetti G. Pulse-dose radiofrequency for knee osteoartrithis. Cardiovasc Intervent Radiol. 2014 Apr;37(2):482-7. doi: 10.1007/s00270-013-0694-z. Epub 2013 Aug 14.'}, {'pmid': '21872812', 'type': 'BACKGROUND', 'citation': 'Karaman H, Tufek A, Kavak GO, Yildirim ZB, Uysal E, Celik F, Kaya S. Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis. J Chin Med Assoc. 2011 Aug;74(8):336-40. doi: 10.1016/j.jcma.2011.06.004. Epub 2011 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'Pulsed radiofrequency (PRF) is designed to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue. In contrast with conventional radiofrequency, PRF is controlled below 42°C without damage to nerves and many studies have shown its benefits in pain relief for certain kinds of chronic pain conditions. For lessening pain of certain joint arthropathy, the direct nerve block by application of PRF is difficult and complicated because the supplying nerve of joint is complex or small. Hence, some authors perform intra-articular PRF on the chronic painful joint for example, knee osteoarthritis, atlantoaxial joint, cervical facet joint sacroiliac joint, scapholunate and shoulder joint and the excellent long-term effects are reported.\n\nThe purpose of this study is to investigate the effect of intra-articular PRF in osteoarthritis.', 'detailedDescription': 'Pulsed radiofrequency (PRF) is designed to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue. In contrast with conventional radiofrequency, PRF is controlled below 42°C without damage to nerves and many studies have shown its benefits in pain relief for certain kinds of chronic pain conditions. For lessening pain of certain joint arthropathy, the direct nerve block by application of PRF is difficult and complicated because the supplying nerve of joint is complex or small. Hence, some authors perform intra-articular PRF on the chronic painful joint for example, knee osteoarthritis, atlantoaxial joint, cervical facet joint sacroiliac joint, scapholunate and shoulder joint and the excellent long-term effects are reported.\n\nHowever, the definite effect of intra-articular PRF for osteoarthritis from current published studies are insufficiently proved because of small patient numbers and lack of placebo-controlled design. The purpose of this study is to investigate the effect of intra-articular PRF in osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 30-75 year-old\n* Clear consciousness\n* No receive steroid injection, hyaluronic acid, platelet rich plasma in past 6 months\n* The pain (VAS) more than 4\n* Symptom duration at least 6 months\n\nExclusion Criteria:\n\n* Cancer\n* Joint contracture\n* Coagulopathy\n* Pregnancy\n* Status of Pacemaker\n* Inflammation status\n* Operative history of treated joint'}, 'identificationModule': {'nctId': 'NCT02436434', 'briefTitle': 'The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis', 'orgStudyIdInfo': {'id': 'TriServiceGH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'pulsed radiofrequency', 'description': 'Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint', 'interventionNames': ['Device: pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham pulsed radiofrequency', 'description': 'Sham intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in controlled joint', 'interventionNames': ['Device: pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)']}], 'interventions': [{'name': 'pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)', 'type': 'DEVICE', 'description': 'Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint', 'armGroupLabels': ['Sham pulsed radiofrequency', 'pulsed radiofrequency']}]}, 'contactsLocationsModule': {'locations': [{'zip': '886', 'city': 'Taipei', 'state': 'Neihu District', 'country': 'Taiwan', 'facility': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '886', 'city': 'Taipei', 'state': 'Neihu District', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital, National Defense Medical Center,', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yung-Tsan Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician, Department of Physical Medicine and Rehabilitation', 'investigatorFullName': 'Yung-Tsan Wu', 'investigatorAffiliation': 'Tri-Service General Hospital'}}}}