Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-28 @ 5:37 PM
Study NCT ID:
NCT02859168
Status:
COMPLETED
Last Update Posted:
2021-10-18
First Post:
2016-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myofascial Induction in Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-13', 'studyFirstSubmitDate': '2016-08-01', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS). Change scores', 'timeFrame': 'A wash-up period of 4 weeks between the 2 sessions was established', 'description': "A numerical rating scale that contains scores in the range of 0 to 10 (0 = 'no pain/anxiety'; 10 = 'worst imaginable pain/anxiety level'). Participants must mark the level of pain that they feel at that moment in the cervical-arm area and use the scale to indicate their anxiety level."}], 'secondaryOutcomes': [{'measure': 'Goniometry shoulder. Change scores', 'timeFrame': 'A wash-up period of 4 weeks between the 2 sessions was established', 'description': 'A plastic universal goniometer with two adjustable overlapping arms to measure the active range of motion of the shoulder joint.'}, {'measure': 'Goniometry cervical. Change scores', 'timeFrame': 'A wash-up period of 4 weeks between the 2 sessions was established', 'description': 'A cervical goniometric device manufactured by Performance Attainment Associates (St Paul, MN, USA) to measure the active range of motion of the cervical joints.'}, {'measure': 'Profile of Mood States (POMS). Change scores', 'timeFrame': 'A wash-up period of 4 weeks between the 2 sessions was established', 'description': 'This questionnaire is a measure of psychological distress. This questionnaire contains 65 items assessing mood state, which are grouped into six subscales: tension-anxiety, depression-dejection, anger-hostility, vigour-activity, fatigue-inertia and confusion-bewilderment.'}, {'measure': 'Attitudes toward massage (ATOM) scale', 'timeFrame': 'Covariates', 'description': "The Attitudes toward massage (ATOM) scale is a nine-item measure of overall attitude toward massage composed of the 'Massage as Healthful' and the 'Massage as Pleasant' subscales."}]}, 'conditionsModule': {'keywords': ['Neck', 'Shoulder', 'Manual Therapies'], 'conditions': ['Pain', 'Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '28003133', 'type': 'RESULT', 'citation': 'Castro-Martin E, Ortiz-Comino L, Gallart-Aragon T, Esteban-Moreno B, Arroyo-Morales M, Galiano-Castillo N. Myofascial Induction Effects on Neck-Shoulder Pain in Breast Cancer Survivors: Randomized, Single-Blind, Placebo-Controlled Crossover Design. Arch Phys Med Rehabil. 2017 May;98(5):832-840. doi: 10.1016/j.apmr.2016.11.019. Epub 2016 Dec 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to show the immediate effects of myofascial induction on perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors suffering shoulder/arm morbidity.', 'detailedDescription': 'Background: To investigate the immediate effects of myofascial induction on perceived pain and anxiety, cervical/shoulder range of motion and mood state in breast cancer survivors suffering shoulder/arm morbidity.\n\nMethods: Randomized, single-blind, placebo-controlled cross-over study. Twenty-one enrolled participants who had a diagnosis of breast cancer stage I-IIIA and had completed adjuvant therapy except hormonal treatment. The study consisted of two intervention sessions of 30 minutes separated by a wash-up period of 4 weeks. The interventions consisted of a Myofascial Induction (experimental group) or placebo pulsed shortwave therapy (control group). The main outcome measures were: Visual Analogue Scale for pain and anxiety, shoulder-cervical goniometry for range of motion, Profile of Mood States for psychological distress and Attitudes Toward Massage Scale.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* had a diagnosis of breast cancer (cancer stage I-IIIA)\n* was between the ages of 25 and 65\n* had completed adjuvant therapy except hormonal treatment\n\nExclusion Criteria:\n\n* had cancer recurrence'}, 'identificationModule': {'nctId': 'NCT02859168', 'briefTitle': 'Myofascial Induction in Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Randomized, Single-blind, Placebo-controlled Cross-over Design of Myofascial Induction and Placebo Electrotherapy in Breast Cancer Survivors', 'orgStudyIdInfo': {'id': 'FIS PI10/02749-02764'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myofascial Induction session', 'description': 'Patients received a Myofascial Induction focused on the upper limb area for 30 minutes using the Pilat approach.', 'interventionNames': ['Behavioral: Myofascial Induction']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo session', 'description': 'Patients received a placebo session consisted of 30 minutes of unplugged pulsed shortwave therapy.', 'interventionNames': ['Device: Unplugged pulsed shortwave therapy']}], 'interventions': [{'name': 'Myofascial Induction', 'type': 'BEHAVIORAL', 'description': 'Patients received a Myofascial Induction focused on the upper limb area for 30 minutes using the Pilat approach.', 'armGroupLabels': ['Myofascial Induction session']}, {'name': 'Unplugged pulsed shortwave therapy', 'type': 'DEVICE', 'description': 'Patients received a placebo session consisted of 30 minutes of unplugged pulsed shortwave therapy.', 'armGroupLabels': ['Placebo session']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18016', 'city': 'Granada', 'country': 'Spain', 'facility': 'Faculty of Health Sciences. University of Granada', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'Manuel Arroyo-Morales, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deparment of Physical Therapy, Faculty of Health Sciences, University of Granada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Manuel Arroyo Morales', 'investigatorAffiliation': 'Universidad de Granada'}}}}