Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-30 @ 9:36 PM
Study NCT ID:
NCT01866332
Status:
COMPLETED
Last Update Posted:
2015-01-15
First Post:
2013-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D001458', 'term': 'Bandages'}, {'id': 'D055052', 'term': 'Athletic Tape'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-14', 'studyFirstSubmitDate': '2013-05-28', 'studyFirstSubmitQcDate': '2013-05-30', 'lastUpdatePostDateStruct': {'date': '2015-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Satisfaction with care', 'timeFrame': '5 weeks after randomization', 'description': 'Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care'}], 'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': 'Five weeks after randomization', 'description': 'Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)'}, {'measure': 'Disability', 'timeFrame': 'Five weeks after randomization', 'description': 'Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '3 and 6 months after randomization', 'description': 'Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)'}, {'measure': 'Disability', 'timeFrame': '3 and 6 months after randomization', 'description': 'Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionnaire'}, {'measure': 'Global impression of recovery', 'timeFrame': '5 weeks, 3 and 6 months after randomization', 'description': 'Global impression of recovery will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['back pain', 'tape', 'chronic'], 'conditions': ['Nonspecific Chronic Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '27266883', 'type': 'DERIVED', 'citation': 'Added MA, Costa LO, de Freitas DG, Fukuda TY, Monteiro RL, Salomao EC, de Medeiros FC, Costa Lda C. Kinesio Taping Does Not Provide Additional Benefits in Patients With Chronic Low Back Pain Who Receive Exercise and Manual Therapy: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2016 Jul;46(7):506-13. doi: 10.2519/jospt.2016.6590. Epub 2016 Jun 6.'}], 'seeAlsoLinks': [{'url': 'http://www.bv.fapesp.br/pt/pesquisador/665136/luciola-da-cunha-menezes-costa/', 'label': 'Info from the grant sponsor of this study (FAPESP, Brazil)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of the addition of the use of Kinesio Taping in patients with chronic nonspecific low back pain who receive conventional physical therapy.', 'detailedDescription': 'One hundred and forty-eight patients will be randomized to receive either conventional physical therapy, which consist of a combination of manual therapy techniques, general exercises and specific exercises for spinal segmental stabilization (Conventional Physical Therapy Group) or to receive conventional physical therapy plus the addition of the Kinesio Taping in the lumbar spine (Conventional Physical Therapy plus Kinesio Taping), over a period of 5 weeks (10 sessions of treatment).\n\nClinical outcomes (pain intensity, disability and global perceived effect ) will be collected at baseline and at 5 weeks, 3 and 6 months after randomization. Data will be collected by a blinded examiner who will be unaware about the group allocation. All statistical analysis will be conducted following the principles of intention to treat analysis and the between-group differences will be performed using Mixed Linear Models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with non-specific low back pain longer than 12 weeks\n* Seeking care for low back pain\n\nExclusion Criteria:\n\n* Contra indications to physical exercise\n* Serious spinal pathologies (e.g. tumors, fractures and inflammatory diseases)\n* Nerve root compromise\n* Contra indications to the Kinesio Taping (e.g. intolerance to tapes, band aids etc)\n* Pregnancy\n* Severe cardiorespiratory conditions'}, 'identificationModule': {'nctId': 'NCT01866332', 'briefTitle': 'Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Cidade de Sao Paulo'}, 'officialTitle': 'Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FAPESP2013/02075-8'}, 'secondaryIdInfos': [{'id': '02075-8', 'type': 'OTHER_GRANT', 'domain': 'FAPESP, Brazil'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Physical Therapy', 'description': 'Combination of manual therapy techniques, general exercises and specific exercises for spinal segmental stabilization. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). The treatment will be tailored to the patient presentation (i.e. pragmatic treatment).', 'interventionNames': ['Other: Conventional Physical Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional Physical Therapy plus Kinesiotaping', 'description': 'Patients will receive conventional physical therapy plus an application of Kinesiotaping in their lumbar spine.\n\nPatients will receive 10 sessions of treatment over a period of five weeks (two sessions/week).', 'interventionNames': ['Other: Conventional Physical Therapy', 'Device: Kinesio Tex Gold ( Kinesiotaping )']}], 'interventions': [{'name': 'Conventional Physical Therapy', 'type': 'OTHER', 'otherNames': ['Manual therapy', 'Exercise therapy', 'Specific exercises'], 'description': 'Combination of manual therapy techniques, general exercises and specific exercises for spinal segmental stabilization. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). The treatment will be tailored to the patient presentation (i.e. pragmatic treatment).', 'armGroupLabels': ['Conventional Physical Therapy', 'Conventional Physical Therapy plus Kinesiotaping']}, {'name': 'Kinesio Tex Gold ( Kinesiotaping )', 'type': 'DEVICE', 'otherNames': ['Bandages', 'Tape', 'Taping', 'Kinesio Tex', 'Kinesio Tape', 'Kinesiotape'], 'description': 'Kinesiotaping 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 superficial back muscles (erector spinae muscles).', 'armGroupLabels': ['Conventional Physical Therapy plus Kinesiotaping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03071000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Physical Therapy Outpatient Department', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Luciola CM Costa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Cidade de São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Cidade de Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Luciola da Cunha Menezes Costa', 'investigatorAffiliation': 'Universidade Cidade de Sao Paulo'}}}}