Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-04-19 @ 1:33 AM
Study NCT ID:
NCT02366793
Status:
COMPLETED
Last Update Posted:
2015-09-16
First Post:
2015-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accessory Joint and Neural Mobilizations in Shoulder After Breast Cancer Surgery. Randomized Clinical Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-15', 'studyFirstSubmitDate': '2015-01-17', 'studyFirstSubmitQcDate': '2015-02-11', 'lastUpdatePostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder Range of motion', 'timeFrame': '15 min', 'description': 'Shoulder movements measured: flexion, extension, abduction, external e internal rotation.\n\nMeasure instrument: inclinometer. Unit of measure: degrees. Number of participants: 18.'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': '5 min', 'description': 'Measure instrument: Visual Analogue Scale to measure the grade of pain: scale from 0 (no pain) to 10 (unbearable pain). Patients choose where is located their pain throughout this scale.\n\nUnit of measure: from 0 to 10 points. Number of participants: 18.'}, {'measure': 'Upper limb functionality', 'timeFrame': '10 min', 'description': "Measured items: daily life activities related to the upper limb such as to comb, to get washed, to button the bra, to mop the floor, to clean windows, to hang up, to make the bed, to carry the shopping cart, to put on the pullover, to take off the pullover, leisure.\n\nMeasure instrument: the Wingate's Daily Life Activities Table to measure the daily life activities difficulty. Patients give a score of how difficult is each daily life activity. Score from 0 (no difficulty) to 3 (disability).\n\nUnit of measure: from 0 to 3 points. Number of participants: 18."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['accessory mobilization, nerve mobilization.'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The potential consequences after breast cancer surgery are joint pain and sensitive disorders, the main sign of which is alterations in shoulder mobility. Global kinesitherapy has been shown to be effective at increasing shoulder range of motion restriction. However, literature does not consider specific manual therapy techniques, which means peripheral nerves and articular capsule have not been taken into account. These two tissues are potentially damaged structures during surgery and they are main responsible for shoulder range of motion restriction The main objective of this study is to pilot the effectiveness of accessory joint and nerve mobilization techniques in order to get an overview of the articular capsule and nerve dysfunctions involvement in shoulder motion restriction.', 'detailedDescription': 'Background: The potential consequences after breast cancer surgery are joint pain and sensitive disorders, the main sign of which is alterations in shoulder mobility. Design: Prospective randomized and double-blind pilot trial. Objective: To pilot the effectiveness of accessory joint and nerve mobilization techniques in order to get an overview of the joint capsule and nerve involvement in shoulder motion restriction. Participants: 18 women who were undergoing unilateral breast cancer surgery and axillary lymph node dissection. Setting: Women´s Health Research Group at Physical Therapy Department of University of Alcala, Madrid, Spain. Intervention: accessory joint mobilization versus neural mobilization. Follow-up: Six-month follow-up. Key outcomes: Range of motion, sensitive disorder, pain and upper limb functionality.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral breast cancer diagnosis\n* breast cancer with axillary lymph node dissection\n* be willing to sign the informed consent form\n\nExclusion Criteria:\n\n* bilateral breast cancer diagnosis\n* loco-regional recurrence\n* systemic disease\n* had not undergone the axillary lymph node dissection approach\n* to present any contraindication for Physical Therapy.'}, 'identificationModule': {'nctId': 'NCT02366793', 'briefTitle': 'Accessory Joint and Neural Mobilizations in Shoulder After Breast Cancer Surgery. Randomized Clinical Trial.', 'organization': {'class': 'OTHER', 'fullName': 'University of Alcala'}, 'officialTitle': 'Accessory Joint and Neural Mobilizations in Shoulder Range of Motion Restriction After Breast Cancer Surgery. A Pilot Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'UAlcala'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Accessory joint mobilization', 'description': 'Humeral head slides, anterior, posterior and caudal slides.', 'interventionNames': ['Other: Accessory joint mobilization']}, {'type': 'EXPERIMENTAL', 'label': 'Nerve mobilization', 'description': 'neural tissue longitudinal slide using the median neurodynamic test 1 (Butler).', 'interventionNames': ['Other: Nerve mobilization']}], 'interventions': [{'name': 'Accessory joint mobilization', 'type': 'OTHER', 'description': 'Three kinds of humeral head slides: anterior, posterior and caudal slides. Subjects remained in supine position during the whole treatment. The techniques were applied in a rhythmical way, with 2 seconds of slide/traction and then a 2-second break. Each technique was carried out for 2 minutes.', 'armGroupLabels': ['Accessory joint mobilization']}, {'name': 'Nerve mobilization', 'type': 'OTHER', 'description': 'Neural tissue longitudinal slide using the median neurodynamic test 1 (MNT1) that was described by Butler. The proximal parameters (scapular depression, abduction and humeral external rotation) were introduced with maximum neural tension. On the other hand, the distal parameters (supination, elbow extension, wrist and fingers extension) received the remaining tension that the neural tissue allowed. The parameters were introduced sequentially in the order exposed', 'armGroupLabels': ['Nerve mobilization']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MARÍA TORRES-LACOMBA, DOCTOR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SUPERVISOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alcala', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Irene de la Rosa Díaz', 'investigatorFullName': 'IRENE DE LA ROSA DÍAZ', 'investigatorAffiliation': 'University of Alcala'}}}}