Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-03-04 @ 5:58 AM
Study NCT ID:
NCT03703193
Status:
COMPLETED
Last Update Posted:
2018-12-28
First Post:
2018-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dry Needling for Shoulder Pain in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}, '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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-27', 'studyFirstSubmitDate': '2018-10-06', 'studyFirstSubmitQcDate': '2018-10-09', 'lastUpdatePostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in post-dry needling pain intensity with a numerical pain rate scale before and after the intervention', 'timeFrame': 'Baseline, 24 hours (1 day) after and 72 hours (3 days) after treatment the intervention', 'description': 'A Numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness in the targeted area'}], 'secondaryOutcomes': [{'measure': 'Changes in spontaneous shoulder pain with a numerical pain rate scale before and after the intervention', 'timeFrame': 'Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the intervention', 'description': 'A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous shoulder pain'}, {'measure': 'Presence of active trigger points in the shoulder musculature', 'timeFrame': 'Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the intervention', 'description': 'Manual palpation of active trigger points in the shoulder muscles will be conducted'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Spasticity and pain, particularly int he shoulder region, are the most common impairments experienced by subjects who had experienced a stroke. There is preliminary evidence supporting the role of dry needling for spasticity in patients who had suffered from a stroke. Few data exists on the effects on shoulder pain. In addition, it has been shown that application of dry needling induces post-needling soreness in individuals with musculoskeletal pain. No previous study has investigated the presence and the duration of post-needling soreness in individuals who had experienced a stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first-ever unilateral stroke;\n* hemiplegia resulting from stroke;\n* age between 30 and 60 years old;\n* presence of hypertonicity in the upper extremity;\n* pain symptoms in the shoulder\n* active trigger points in the shoulder muscles reproducing the shoulder pain symptoms\n\nExclusion Criteria:\n\n* recurrent stroke;\n* absence of active trigger points in the shoulder muscles reproducing shoulder symptoms\n* previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time;\n* previous treatment with botulinum toxin-A in the 6 months prior the study;\n* severe cognitive deficits;\n* other neurologic diseases,\n* underlying complex medical conditions, e.g., heart conditions, unstable hypertension, fracture\n* fear to needles;\n* any contraindication for deep dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.'}, 'identificationModule': {'nctId': 'NCT03703193', 'briefTitle': 'Dry Needling for Shoulder Pain in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Rey Juan Carlos'}, 'officialTitle': 'Dry Needling for Shoulder Pain and Presence of Post-needling Induced-Pain in PAtients Who Had Suffered a Stroke', 'orgStudyIdInfo': {'id': 'URJC1512201600817'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dry needling', 'description': 'The experimental group will receive a single session of modulatory interventions combined with a single session of dry needling into the shoulder muscles which active trigger points will reproduce the shoulder pain symptoms.', 'interventionNames': ['Other: Dry Needling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physical Therapy', 'description': 'This group will receive a single session of modulatory interventions targeting modulation of central nervous system.', 'interventionNames': ['Other: Physical Therapy']}], 'interventions': [{'name': 'Dry Needling', 'type': 'OTHER', 'description': 'A single session of modulatory interventions combined with a single session of dry needling into the shoulder muscles which active trigger points will reproduce the shoulder pain symptoms.', 'armGroupLabels': ['Dry needling']}, {'name': 'Physical Therapy', 'type': 'OTHER', 'description': 'A single session of modulatory interventions targeting modulation of central nervous system.', 'armGroupLabels': ['Physical Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28922', 'city': 'Alcorcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'César Fernández-de-las-Peñas', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Rey Juan Carlos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department', 'investigatorFullName': 'César Fernández-de-las-Peñas', 'investigatorAffiliation': 'Universidad Rey Juan Carlos'}}}}