Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-02-02 @ 4:58 AM
Study NCT ID:
NCT02007668
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2013-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Kinesio Taping More Effective Than Medical Adhesive Tape in Patients With Chronic Non-specific Low Back Pain?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001458', 'term': 'Bandages'}, {'id': 'D055052', 'term': 'Athletic Tape'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-05', 'studyFirstSubmitDate': '2013-11-30', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '2 days', 'description': 'Pain Intensity will be measured in 2 and 7 days after randomization by an 11-point (0-10) Numerical Rating Scale (Pain NRS)'}], 'secondaryOutcomes': [{'measure': 'Disability', 'timeFrame': '2 days', 'description': 'Disability associated with low back pain will be measured in 2 and 7 days after randomization by the 24-item Roland Morris Disability Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['low back pain', 'kinesio taping'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Sixty patients will be randomized into three groups to receive the Kinesio taping, placebo Kinesio taping (medical adhesive tape) and control group. The group Kinesio taping receive the correct application of the method described. The placebo group will receive a medical adhesive tape. The control group will not receive any form of intervention.', 'detailedDescription': 'The group Kinesio taping receive the correct application of the method described with tension paper off (10-15%). The placebo group will receive a medical adhesive tape. The control group will not receive any form of intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with non-specific low back pain longer than 3 months\n* Seeking care for low back pain\n\nExclusion Criteria:\n\n* Contra indications to any bandage\n* Serious sinal pathologies (e.g. tumors, fractures and inflammatory diseases)\n* Nerve roto compromise\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02007668', 'briefTitle': 'Is Kinesio Taping More Effective Than Medical Adhesive Tape in Patients With Chronic Non-specific Low Back Pain?', 'organization': {'class': 'OTHER', 'fullName': 'Paulista University'}, 'officialTitle': 'Is Kinesio Taping More Effective Than Medical Adhesive Tape in Patients With Chronic Non-specific Low Back Pain? A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CAAE:16832013.9.0000.5512'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kinesio Taping', 'description': 'Patients will receive an application of Kinesio taping in their lumbar spine.', 'interventionNames': ['Other: Kinesio Taping']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Kinesio Taping Placebo', 'description': 'Patients will receive an application of medical adhesive tape in their lumbar spine.'}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This participants will not receive intervention'}], 'interventions': [{'name': 'Kinesio Taping', 'type': 'OTHER', 'otherNames': ['-Bandages', '-Tape', '-Taping', '-Kinesio Tex', '-Kinesio Tape', '-Kinesiotape'], 'description': 'Kinesio taping intervention is based upon the use of specific elastic tapes (known as Kinesio Tex Gold) that are applied with a certain amount of tension fixed to the skin of patients with the target muscles in a stretched position. The tapes will be placed over the lumbar spine.', 'armGroupLabels': ['Kinesio Taping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13214-525', 'city': 'Jundiaí', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Paulista - UNIP', 'geoPoint': {'lat': -23.18639, 'lon': -46.88417}}], 'overallOfficials': [{'name': 'Mauricio Antonio da Luz Junior, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Paulista University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paulista University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Kinesio Taping is More Effective Than Medical Adhesive Tape in Patients With Chronic Non-specific Low Back Pain? A Randomized Controlled Trial', 'investigatorFullName': 'Mauricio Antonio da Luz Junior', 'investigatorAffiliation': 'Paulista University'}}}}