Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-22 @ 5:22 AM
Study NCT ID:
NCT02224261
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2014-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2014-08-20', 'studyFirstSubmitQcDate': '2014-08-22', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in QoL related to shoulder pain at one month (post-intervention); and 3 and 6 months post-intervention', 'timeFrame': 'Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention', 'description': 'Oxford Shoulder Score'}], 'primaryOutcomes': [{'measure': 'Change from baseline in Subjective pain at one month (post-intervention); and 3 and 6 months post-intervention', 'timeFrame': 'Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention', 'description': 'Visual Analogue Scale'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Range of shoulder motion at one month (post-intervention); and 3 and 6 months post-intervention', 'timeFrame': 'Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention', 'description': 'Inclinometer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Axillary web syndrome', 'cording', 'physical therapy', 'breast cancer'], 'conditions': ['Axillary Web Syndrome']}, 'referencesModule': {'references': [{'pmid': '19306057', 'type': 'BACKGROUND', 'citation': 'Torres Lacomba M, Mayoral Del Moral O, Coperias Zazo JL, Yuste Sanchez MJ, Ferrandez JC, Zapico Goni A. Axillary web syndrome after axillary dissection in breast cancer: a prospective study. Breast Cancer Res Treat. 2009 Oct;117(3):625-30. doi: 10.1007/s10549-009-0371-8. Epub 2009 Mar 21.'}, {'pmid': '35079831', 'type': 'RESULT', 'citation': 'Torres-Lacomba M, Prieto-Gomez V, Arranz-Martin B, Ferrandez JC, Yuste-Sanchez MJ, Navarro-Brazalez B, Romay-Barrero H. Manual Lymph Drainage With Progressive Arm Exercises for Axillary Web Syndrome After Breast Cancer Surgery: A Randomized Controlled Trial. Phys Ther. 2022 Mar 1;102(3):pzab314. doi: 10.1093/ptj/pzab314.'}]}, 'descriptionModule': {'briefSummary': 'Objective: To determine the effectiveness of physical therapy on the axillary web syndrome in improving pain, reducing swelling and increasing mobility of the shoulder. Design: randomized single-blinded controlled trial. Follow-up: five physical therapy assessments: pre-intervention; post-intervention, 3 months post-intervention, 6 months post-intervention. Participants: Eighty consecutive women diagnosed with axillary web syndrome after undergoing unilateral breast cancer surgery with ALND or SLND at the Prıíncipe de Asturias Hospital in Alcalà de Henares, Madrid (Spain). Randomization: women will be randomly assigned to two groups by EpiData 3.1 software. Interventions: Physical Therapy group: Physical Therapy composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises; Control group: standard progressive active and action-assisted arm exercises. 9 physical therapy sessions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral breast cancer;\n* Breast surgery with lymphadenectomy and / or sentinel lymph node biopsy;\n* Axillary web syndrome in chest and / or upper limb of the operated side;\n* VAS\\>3\n* Consent to participate in the study;\n* No contraindications for physical therapy (infection, metastasis);\n\nExclusion Criteria:\n\n* Cognitive impairment;\n* Visual impairment for reading;\n* Lymphedema;\n* Bilateral breast cancer;\n* Systemic disease (metastases),\n* Infection;\n* Locoregional recurrence.'}, 'identificationModule': {'nctId': 'NCT02224261', 'acronym': 'PTaws', 'briefTitle': 'Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Alcala'}, 'officialTitle': 'Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '11/032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical Therapy', 'description': 'Physical therapy protocol includes manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises "stretching" cords and patient education.', 'interventionNames': ['Other: Physical Therapy protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control protocol includes standard progressive active and action-assisted arm exercises \\& patient education.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Physical Therapy protocol', 'type': 'OTHER', 'otherNames': ['PT-AWS'], 'description': 'Physical therapy protocol includes manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises "stretching" cords, and patient education.', 'armGroupLabels': ['Physical Therapy']}, {'name': 'Control', 'type': 'OTHER', 'otherNames': ['CG'], 'description': 'Control protocol includes standard progressive active and action-assisted arm exercises \\& patient education.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28871', 'city': 'Alcalà de Henares', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Physiotherapy in women´s health research group. University of Alcalà'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alcala', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario Principe de Asturias', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Maria Torres Lacomba', 'investigatorAffiliation': 'University of Alcala'}}}}