Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-02-21 @ 9:48 PM
Study NCT ID:
NCT02291159
Status:
COMPLETED
Last Update Posted:
2014-12-31
First Post:
2014-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of DNHS Technique in the Treatment of Upper Limb Spasticity and Function in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079245', 'term': 'Dry Needling'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-30', 'studyFirstSubmitDate': '2014-11-10', 'studyFirstSubmitQcDate': '2014-11-13', 'lastUpdatePostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl Meyer Assessment Scale (Motor Function)', 'timeFrame': 'Two weeks'}], 'secondaryOutcomes': [{'measure': 'Modified Ashworth Scale (Hypertonia/Spasticity)', 'timeFrame': 'Two weeks'}, {'measure': 'Impact Stroke Scale (Quality of Life)', 'timeFrame': 'Two weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'spasticity', 'dry needling', 'upper motor neuron syndrome', 'motor function'], 'conditions': ['Stroke', 'Spasticity']}, 'descriptionModule': {'briefSummary': 'Introduction: Stroke is a neurological deficit caused by a decrease in cerebral blood flow. The DNHS ® (Dry Needling for hypertonia and Spasticity) technique is a dry needling technique to reduce spasticity and hypertonia and improve function in patients with CNS injury. The main objective of this trial is to analyze the therapeutic effect of DNHS® technique in motor function in patients between 45 and 80 in a chronic state after a stroke. Methods: Double-blinded randomized clinical trial. There will be an intervention group (DNHS® technique) and a sham control group. The intervention will be 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei. The Fugl Meyer Assessment Scale, Modified Ashworth Scale and Stroke Impact Scale will be used as outcome measures. The data will be expressed as mean ± (Standard Deviation). The standardized difference or effect size (ES, 90% confidence limit) in the selected variables will be calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* people aged 40-85 years with hemiplegia resulting from stroke of more than 6 months evolution (chronic stroke)\n* ability to follow instructions and reply to assessment questonnaires\n\nExclusion Criteria:\n\n* recurrent stroke episodes\n* other concomitant neurodegenerative conditions\n* fear to needles\n* participation in a parallel study\n* any absolute contraindication for deep dry needling'}, 'identificationModule': {'nctId': 'NCT02291159', 'briefTitle': 'Effects of DNHS Technique in the Treatment of Upper Limb Spasticity and Function in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Universidad San Jorge'}, 'officialTitle': 'Effectiveness of Dry Needling (DNHS Technique) in the Treatment of Upper Limb Spasticity and Function in Stroke Patients: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'USJ_DNHS_UL_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention-DNHS technique', 'description': 'Dry needling of Myofascial Trigger Points', 'interventionNames': ['Device: DNHS ® (Dry Needling for Hypertonia and Spasticity)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control-Sham Dry Needling', 'description': 'Sham Dry Needling of Myofascial Trigger Points', 'interventionNames': ['Device: Sham Dry Needling']}], 'interventions': [{'name': 'DNHS ® (Dry Needling for Hypertonia and Spasticity)', 'type': 'DEVICE', 'description': 'Dry needling of Myofascial Trigger Points. 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei', 'armGroupLabels': ['Intervention-DNHS technique']}, {'name': 'Sham Dry Needling', 'type': 'DEVICE', 'description': 'Sham dry needling of Myofascial Trigger Points. 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei', 'armGroupLabels': ['Control-Sham Dry Needling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50830', 'city': 'Villanueva de Gállego', 'state': 'Zaragoza', 'country': 'Spain', 'facility': 'San Jorge University', 'geoPoint': {'lat': 41.76917, 'lon': -0.8235}}], 'overallOfficials': [{'name': 'Herrero Pablo, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'San Jorge University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad San Jorge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Pablo Herrero Gallego', 'investigatorFullName': 'Pablo Herrero Gallego', 'investigatorAffiliation': 'Universidad San Jorge'}}}}