Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-03-05 @ 3:01 PM
Study NCT ID:
NCT02377804
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2015-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dry Needling for Spasticity 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'}, {'id': 'D010146', 'term': 'Pain'}], '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'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-05', 'studyFirstSubmitDate': '2015-02-27', 'studyFirstSubmitQcDate': '2015-03-03', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in spasticity before and after the intervention', 'timeFrame': 'Baseline and immediate after the interventionBaseline (1 week before) and 1 week after intervention', 'description': 'Spasticity in the affected ankle joint will be evaluated with the Modified Modified Ashworth Scale (MMAS). The examiner passively moved the upper extremity in a stretching direction of each muscle (shoulder depression, shoulder external rotation, shoulder internal rotation, and shoulder abduction 90º combined with external rotation, respectively), back and forth at least 5 times and evaluated the degree of resistance to the movement on a scale from 0-4'}], 'secondaryOutcomes': [{'measure': 'Changes in pressure pain sensitivity before and after the intervention', 'timeFrame': 'Baseline (1 week before) and 1 week after intervention', 'description': 'Pressure pain thresholds, defined as the amount of pressure applied for the pressure sensation to first change to pain, will be assessed with a mechanical pressure algometer (Pain Diagnosis and Treatment Inc, New York, USA) unilaterally over the affected infraspinatus and deltoid muscles and bilaterally over the C5/C6 zygapophyseal joint.'}, {'measure': 'Changes in shoulder mobility before and after the intervention', 'timeFrame': 'Baseline (1 week before) and 1 week after intervention', 'description': "A universal goniometer will be used to determine the participant's shoulder range of motion in flexion, abduction and external rotation"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dry needling', 'spasticity', 'pain'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Stroke is the leading cause of physical disability due to the presence of spasticity. Different needling techniques, including Botulinum Toxin A are proposed for management of spasticity; however results are conflicting. The presence of spasticity in the upper extremity implies several impairments for daily life activities. No study has investigated the effects of deep dry needling inserted into the targeted spastic musculature of the shoulder region in patients who had suffered a stroke. The investigators will conduct a randomized controlled trial investigating the effects of the inclusion of deep dry needling into a rehabilitation program over the musculature of the shoulder region, pressure pain hyperalgesia and range of motion in individuals with chronic stroke. The investigators hypothesize that patients receiving dry needling into the spastic shoulder musculature would exhibit greater improvements in spasticity, pressure sensitivity and range of motion than those who will not receive the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first-ever unilateral stroke;\n* hemiplegia resulting from stroke;\n* age between 40 and 65 years old;\n* presence of hypertonicity in the upper extremity;\n* restricted range of motion of the shoulder\n\nExclusion Criteria:\n\n* recurrent stroke;\n* previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time;\n* previous treatment with BTX-A in the 6 months prior the study;\n* severe cognitive deficits; 5, progressive or severe neurologic diseases, e.g., heart conditions, unstable hypertension, fracture or implants in the lower extremity;\n* fear to needles;\n* any contraindication for deep dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.'}, 'identificationModule': {'nctId': 'NCT02377804', 'briefTitle': 'Dry Needling for Spasticity in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Rey Juan Carlos'}, 'officialTitle': 'Changes in Spasticity, Range of Motion and Pressure Pain Sensitivity in Patients With Stroke After the Application of Dry Needling in the Shoulder Musculature', 'orgStudyIdInfo': {'id': 'HBMA-URJC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental intervention', 'description': 'The experimental intervention will consist of 3 sessions, one per week, of 45min of physical therapy including mobilizations of the scapular region, manual therapies targeted to decrease muscle tone, neuromodulatory techniques for spasticity and proprioceptive exercises for the upper extremity. In addition, during this intervention patients will also receive deep dry needling with disposable stainless steel needles (0.3mm x 50mm) that will be inserted into the skin over taut bands of the spastic musculature of the shoulder area: upper trapezius, subscapularis, infraspinatus, and pectoralis mayor', 'interventionNames': ['Other: Dry needling', 'Other: Physical Therapy', 'Device: stainless steel needles (0.3mm x 50mm)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control intervention', 'description': 'The control intervention will consist of 3 sessions, one per week, of 45min of physical therapy including mobilizations of the scapular region, manual therapies targeted to decrease muscle tone, neuromodulatory techniques for spasticity and proprioceptive exercises for the upper extremity.', 'interventionNames': ['Other: Physical Therapy']}], 'interventions': [{'name': 'Dry needling', 'type': 'OTHER', 'description': 'Patients will receive deep dry needling with disposable stainless steel needles (0.3mm x 50mm) that will be inserted into the skin over taut bands of the spastic musculature of the shoulder area: upper trapezius, subscapularis, infraspinatus, and pect', 'armGroupLabels': ['Experimental intervention']}, {'name': 'Physical Therapy', 'type': 'OTHER', 'description': 'Patients will receive 3 sessions, one per week, of 45min of physical therapy including mobilizations of the scapular region, manual therapies targeted to decrease muscle tone, neuromodulatory techniques for spasticity and proprioceptive exercises for the upper extremity', 'armGroupLabels': ['Control intervention', 'Experimental intervention']}, {'name': 'stainless steel needles (0.3mm x 50mm)', 'type': 'DEVICE', 'armGroupLabels': ['Experimental intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28922', 'city': 'Alcorcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Universidad Rey Juan Carlos', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Beta María Ana', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'César Fernández-de-las-Peñas', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad Rey Juan Carlos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Rey Juan Carlos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Proffesor', 'investigatorFullName': 'César Fernández-de-las-Peñas', 'investigatorAffiliation': 'Universidad Rey Juan Carlos'}}}}