Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-03-03 @ 4:15 AM
Study NCT ID:
NCT03743818
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2018-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMPARATIVE STUDY OF THE EFFICACY OF HYALURONIC ACID, DRY NEEDLING AND COMBINED TREATMENT IN PATELLAR 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079245', 'term': 'Dry Needling'}, {'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2018-11-11', 'studyFirstSubmitQcDate': '2018-11-15', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': '1 month', 'description': 'Pain 0 maximum pain score---------10 minimum pain score'}], 'secondaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale)', 'timeFrame': '1 month', 'description': 'scale with questions to mesure pain,(5 questions), stiffness (2 questions) and physical function (17 questions). There are five answers in each questions: none, mild, moderate, severe and extreme.'}, {'measure': 'International Physical Activity Questionnaire scale', 'timeFrame': '1 month', 'description': 'questions to mesure physical activity. 7 questions about the time that employed the patients in activities physical ( hours/day, minutes/day, days/week or any activity).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '28445290', 'type': 'RESULT', 'citation': 'Velazquez-Saornil J, Ruiz-Ruiz B, Rodriguez-Sanz D, Romero-Morales C, Lopez-Lopez D, Calvo-Lobo C. Efficacy of quadriceps vastus medialis dry needling in a rehabilitation protocol after surgical reconstruction of complete anterior cruciate ligament rupture. Medicine (Baltimore). 2017 Apr;96(17):e6726. doi: 10.1097/MD.0000000000006726.'}, {'pmid': '29952993', 'type': 'RESULT', 'citation': 'Sanchez-Romero EA, Pecos-Martin D, Calvo-Lobo C, Ochoa-Saez V, Burgos-Caballero V, Fernandez-Carnero J. Effects of dry needling in an exercise program for older adults with knee osteoarthritis: A pilot clinical trial. Medicine (Baltimore). 2018 Jun;97(26):e11255. doi: 10.1097/MD.0000000000011255.'}, {'pmid': '28504067', 'type': 'RESULT', 'citation': 'Espi-Lopez GV, Serra-Ano P, Vicent-Ferrando J, Sanchez-Moreno-Giner M, Arias-Buria JL, Cleland J, Fernandez-de-Las-Penas C. Effectiveness of Inclusion of Dry Needling in a Multimodal Therapy Program for Patellofemoral Pain: A Randomized Parallel-Group Trial. J Orthop Sports Phys Ther. 2017 Jun;47(6):392-401. doi: 10.2519/jospt.2017.7389. Epub 2017 May 13.'}, {'pmid': '23606888', 'type': 'RESULT', 'citation': 'Mayoral O, Salvat I, Martin MT, Martin S, Santiago J, Cotarelo J, Rodriguez C. Efficacy of myofascial trigger point dry needling in the prevention of pain after total knee arthroplasty: a randomized, double-blinded, placebo-controlled trial. Evid Based Complement Alternat Med. 2013;2013:694941. doi: 10.1155/2013/694941. Epub 2013 Mar 27.'}]}, 'descriptionModule': {'briefSummary': 'Randomized clinical trial in patients with knee osteoarthritis. Sixty patients will be evaluated, divided in three groups (20 in each). One group A will be treated by dry needling in the vast internal, other group B will be treated with a standardized treatment protocol (electrotherapy and manual therapy), and group C will be treated with hialuronic acid. The investigators want to observe which technique is the most effective in osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with knee pain and diagnosed of osteoarthritis knee and confirm RNM\n* More 18 years.\n* Less 55 years\n\nExclusion Criteria:\n\n* More 55 years.\n* Less 18 years.\n* mental dysfunction\n* those who have any type of complication that can cause myofascial or neuropathic pain in the lower limb, such as lumbo-sacral radiculopathy, neuropraxia, neurothymesis, axonotmesis, or meralgia paraesthetica; who have any condition generally considered to be a factor in perpetuating TrPs, such as fibromyalgia, hypothyroidism, or iron deficiency; and patients who may have a fear of needles (belonephobia) will be excluded.\n\nPatients with lower limb dysmetries of 0.50 cm or more were also excluded from this study.'}, 'identificationModule': {'nctId': 'NCT03743818', 'briefTitle': 'COMPARATIVE STUDY OF THE EFFICACY OF HYALURONIC ACID, DRY NEEDLING AND COMBINED TREATMENT IN PATELLAR OSTEOARTHRITIS', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica de Ávila'}, 'officialTitle': 'COMPARATIVE STUDY OF THE EFFICACY OF HYALURONIC ACID, DRY NEEDLING AND COMBINED TREATMENT IN PATELLAR OSTEOARTHRITIS: NON-CONTROLLED RANDOMIZED CLINICAL TRIAL WITH BLINDED EVALUATOR', 'orgStudyIdInfo': {'id': 'UCAvila'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dry needling', 'description': 'dry needling in trigger point in vastus medialis of quadriceps', 'interventionNames': ['Device: dry needling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standardized treatment protocol', 'description': 'in the standardized treatment protocol the investigators including ultrasound, tens, and isometric quadriceps contractions', 'interventionNames': ['Other: ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hialuronic acid', 'description': 'infiltration of hyaluronic acid in the affected knee', 'interventionNames': ['Device: hyauluronic acid']}], 'interventions': [{'name': 'dry needling', 'type': 'DEVICE', 'description': 'dry needling on the trigger point of the vastus medialis of the quadriceps', 'armGroupLabels': ['dry needling']}, {'name': 'ultrasound', 'type': 'OTHER', 'description': 'aply ultrasound on the knee', 'armGroupLabels': ['standardized treatment protocol']}, {'name': 'hyauluronic acid', 'type': 'DEVICE', 'description': 'aply hyaluronic acid on the knee', 'armGroupLabels': ['hialuronic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05003', 'city': 'Ávila', 'country': 'Spain', 'facility': 'Fisiosalud Avila', 'geoPoint': {'lat': 40.65724, 'lon': -4.69951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica de Ávila', 'class': 'OTHER'}, 'collaborators': [{'name': 'Verónica Prieto Domínguez', 'class': 'UNKNOWN'}, {'name': 'Raúl Vittori', 'class': 'UNKNOWN'}, {'name': 'Ignacio Normand Farias', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'JORGE VELAZQUEZ SAORNIL', 'investigatorAffiliation': 'Universidad Católica de Ávila'}}}}