Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-02-25 @ 3:02 AM
Study NCT ID:
NCT02735967
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
2016-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Diadynamic in Association With a Manual Therapy Program for Patients With Impingement Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'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': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-18', 'studyFirstSubmitDate': '2016-04-02', 'studyFirstSubmitQcDate': '2016-04-06', 'lastUpdatePostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'shoulder disability', 'timeFrame': 'Change from Baseline in the Shoulder Pain and Disability Index at 4 weeks', 'description': 'questionnaire of quality of life developed to assess pain and associated with specific inability to shoulder disorders.'}], 'secondaryOutcomes': [{'measure': 'intensity of pain', 'timeFrame': 'Change from Baseline in The Numerical rating pain scale at 4 weeks', 'description': 'the Numerical rating pain scale, a simple, easily administered scale evaluates'}, {'measure': 'level of pressure pain', 'timeFrame': 'change from Baseline in ThePressure Pain Threshold at 4 weeks', 'description': 'Pressure Pain Threshold in the shoulder with algometer dynamometer.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Shoulder Impingement Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uninove.br', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study will be to evaluate the effects of the use of manual therapy and diadynamic in muscle trigger points in the upper trapezius muscle in individuals diagnosed with shoulder impingement syndrome, unilateral shoulder as functional capacity, pain intensity and pain threshold the pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* history of anterior lateral and unilateral shoulder pain\n* with more than 3 months duration\n* intensity of at least 4 points on the Numerical Rating Pain Scale\n* positivity in at least 2 of 3 orthopedic tests for impingement syndrome: Neer, Hawkins or Jobe\n* Associated with these characteristics volunteers should submit myofascial trigger points unilateral and active, centrally located in the trapezius muscle descending fibers associated with painful shoulder\n\nExclusion Criteria:\n\n* diagnosis of bilateral impingement syndrome shoulder\n* fibromyalgia\n* muscle injury\n* history of trauma on the shoulder\n* ruptured tendons\n* ligamentous laxity\n* symptoms of numbness and / or tingling in the upper limbs\n* corticosteroid injection use shoulder\n* making use of anti-inflammatory\n* they performed surgery or physical therapy treatment in the last 6 months in the affected shoulder.'}, 'identificationModule': {'nctId': 'NCT02735967', 'briefTitle': 'The Use of Diadynamic in Association With a Manual Therapy Program for Patients With Impingement Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'The Use of Diadynamic in Association With a Manual Therapy Program for Patients With Impingement Syndrome: a Randomized Blind Clinical Trial', 'orgStudyIdInfo': {'id': '50917515.3.0000.5511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group manual therapy + diadynamic', 'description': 'Initially, the positional release techniques will be performed while maintaining this position for 90 seconds procedure is repeated 3 times. Then, the therapist performs the ischemic compression technique on the myofascial trigger point, the compression is maintained for 90 seconds by 3 replications.\n\nThrough an electrotherapy device were applied diadynamic in that myofascial trigger point previously marked. 4 minutes from the fixed two-phase mode will be applied (DF), 4 minutes long periods (LP) and 4 minutes short periods (CP), the first and second intensely in the sensitive line and the third motor threshold, both supportable according to each patient.', 'interventionNames': ['Other: manual therapy', 'Device: diadynamic current']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group manual therapy', 'description': 'Initially, the positional release techniques will be performed while maintaining this position for 90 seconds procedure is repeated 3 times. Then, the therapist performs the ischemic compression technique on the myofascial trigger point, the compression is maintained for 90 seconds by 3 replications.', 'interventionNames': ['Other: manual therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group diadynamic', 'description': 'An electrotherapy device were applied diadynamic in that myofascial trigger point previously marked. 4 minutes from the fixed two-phase mode will be applied (DF),4 minutes long periods (LP) and 4 minutes short periods (CP), the first and second intensely in the sensitive line and the third motor threshold, both supportable according to each patient.', 'interventionNames': ['Device: diadynamic current']}], 'interventions': [{'name': 'manual therapy', 'type': 'OTHER', 'description': 'the positional release techniques will be performed while maintaining this position for 90 seconds procedure is repeated 3 times. Then, the therapist performs the ischemic compression technique on the myofascial trigger point, the compression is maintained for 90 seconds by 3 replications.', 'armGroupLabels': ['Group manual therapy', 'Group manual therapy + diadynamic']}, {'name': 'diadynamic current', 'type': 'DEVICE', 'description': 'Through an electrotherapy device were applied diadynamic in that myofascial trigger point previously marked. 4 minutes from the fixed two-phase mode will be applied (DF), 4 minutes long periods (LP) and 4 minute short periods (CP), the first and second intensely in the sensitive line and the third motor threshold, both supportable according to each patient.', 'armGroupLabels': ['Group diadynamic', 'Group manual therapy + diadynamic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01415000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Cid André Fidelis de Paula Gomes', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nove de Julho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd', 'investigatorFullName': 'Cid André Fidelis de Paula Gomes', 'investigatorAffiliation': 'University of Nove de Julho'}}}}