Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-05 @ 6:11 PM
Study NCT ID:
NCT03274557
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2017-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrequence Microtenotomy for Treatment of Achilles Tendinose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'To evaluate improvement of VAS and functionality before and after treatment of Achilles tendinosis using radiofrequency-plasma based microtenotomy in comparison to traditional physical therapy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2017-09-04', 'studyFirstSubmitQcDate': '2017-09-04', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain reduction', 'timeFrame': '6.12 weeks and 6,12 months', 'description': 'Pain reduction. Change of pain from baseline measured with VAS'}], 'secondaryOutcomes': [{'measure': 'Function', 'timeFrame': '6.12 weeks and 6,12 months', 'description': 'Change from baseline in functionality measured by (FAOS) FOOT \\& ANKLE SURVEY'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Achilles, tendinose, tendinopathy, pain'], 'conditions': ['Achilles Pain']}, 'referencesModule': {'references': [{'pmid': '34988234', 'type': 'DERIVED', 'citation': 'Al-Ani Z, Meknas D, Kartus JT, Lyngedal O, Meknas K. Radiofrequency Microtenotomy or Physical Therapy for Achilles Tendinopathy: Results of a Randomized Clinical Trial. Orthop J Sports Med. 2021 Dec 20;9(12):23259671211062555. doi: 10.1177/23259671211062555. eCollection 2021 Dec.'}]}, 'descriptionModule': {'briefSummary': 'Prospective randomized controlled study using radio-frequency microtenotomy or physical therapy (eccentric training) for treatment of Achilles tendinose', 'detailedDescription': 'Achilless tendinosis is a major clinical problem. There is a need for new studies to map the effectiveness of treatment. This study will compare treatment effectiveness between traditional physical therapy with surgical treatment using (RFM). The tendinosis grade will be evaluated using MRI and /or ultrasound before and after intervention. The outcome measurment include VAS and function using ( FAOS FOOT \\& ANKLE SURVEY) at 6,12 weeks and 6, 12 months after intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with pain in Achilles tendon for at least 6 weeks.\n* MR / ultrasound confirms diagnosis tendinose.\n* Pain in sport and daily activities\n\nExclusion Criteria:\n\nOther co-morbidity that constitutes contraindication for surgery, serious illness, bad compliance'}, 'identificationModule': {'nctId': 'NCT03274557', 'acronym': 'RFM', 'briefTitle': 'Radiofrequence Microtenotomy for Treatment of Achilles Tendinose', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'Treatment of Achilles Tendinose', 'orgStudyIdInfo': {'id': '2014/1277/REK sør-øst'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Radiofrequency microtenotomy', 'description': 'Treatment of Achilles tendinose with radio-frequency microtenotomy', 'interventionNames': ['Procedure: RFM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phusical therapy', 'description': 'Supervised eccentric training', 'interventionNames': ['Procedure: RFM']}], 'interventions': [{'name': 'RFM', 'type': 'PROCEDURE', 'armGroupLabels': ['Phusical therapy', 'Radiofrequency microtenotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9038', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}