Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-30 @ 2:20 AM
Study NCT ID:
NCT01919268
Status:
COMPLETED
Last Update Posted:
2015-06-16
First Post:
2013-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addition of the Interferential Current to the Pilates Method in the Treatment of Chronic Nonspecific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, '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': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-15', 'studyFirstSubmitDate': '2013-08-07', 'studyFirstSubmitQcDate': '2013-08-07', 'lastUpdatePostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability', 'timeFrame': 'Six weeks after randomization', 'description': 'Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire'}, {'measure': 'Pressure pain threshold', 'timeFrame': 'Six weeks after randomization', 'description': 'Pressure pain threshold will be evaluated using a pressure algometer'}, {'measure': 'Pain intensity', 'timeFrame': 'Six weeks after randomization', 'description': 'Pain intensity will be measured by an 11-point Pain Numerical Rating Scale'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Six months after randomization', 'description': 'Pain intensity will be measured by an 11-point Pain Numerical Rating Scale'}, {'measure': 'Disability', 'timeFrame': 'Six months after randomization', 'description': 'Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire'}, {'measure': 'Global impression of recovery', 'timeFrame': 'Six weeks and six months after randomization', 'description': 'Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale'}, {'measure': 'Specific disability', 'timeFrame': 'Six weeks and six months after randomization', 'description': 'Specific disability will be evaluated by an 11-point Patient-specific Functional Scale'}, {'measure': 'Kinesiophobia', 'timeFrame': 'Six weeks and six months after randomization', 'description': 'Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pilates-based exercises', 'Electrotherapy', 'Interferencial current'], 'conditions': ['Chronic Nonspecific Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '27771359', 'type': 'DERIVED', 'citation': 'Franco KM, Franco YD, Oliveira NB, Miyamoto GC, Santos MO, Liebano RE, Cabral CN. Is Interferential Current Before Pilates Exercises More Effective Than Placebo in Patients With Chronic Nonspecific Low Back Pain?: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Feb;98(2):320-328. doi: 10.1016/j.apmr.2016.08.485. Epub 2016 Oct 19.'}, {'pmid': '25492853', 'type': 'DERIVED', 'citation': 'Franco YR, Liebano RE, Moura KF, de Oliveira NT, Miyamoto GC, Santos MO, Cabral CM. Efficacy of the addition of interferential current to Pilates method in patients with low back pain: a protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Dec 10;15:420. doi: 10.1186/1471-2474-15-420.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of the addition of the interferential current to Pilates method exercises in the treatment of 148 patients with chronic nonspecific low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sedentary patients with chronic nonspecific low back pain longer than 12 weeks\n* Pain greater than three points in Pain Numerical Rating Scale\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* Pregnancy\n* Infection and/or skin lesions at the site of the application of the interferential current\n* Cancer\n* Cardiac pacemaker\n* Changes in sensitivity or allergy in the region of electrode placement\n* Previous surgery on spine or physical therapy for chronic nonspecific low back pain in the last six months\n* Previous experience with the Pilates method'}, 'identificationModule': {'nctId': 'NCT01919268', 'briefTitle': 'Addition of the Interferential Current to the Pilates Method in the Treatment of Chronic Nonspecific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Cidade de Sao Paulo'}, 'officialTitle': 'Effectiveness of the Addition of the Interferential Current to the Pilates Method in the Treatment of Patients With Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CAAE 18034113.7.0000.0064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electrotherapy', 'description': "Combination of active interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient's needs (pragmatic treatment).", 'interventionNames': ['Device: Electrotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pilates', 'description': "Combination of placebo interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of six weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient's needs (pragmatic treatment).", 'interventionNames': ['Device: Pilates']}], 'interventions': [{'name': 'Electrotherapy', 'type': 'DEVICE', 'description': "Combination of active interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of Pilates method will be individualized to each patient's needs (pragmatic treatment).", 'armGroupLabels': ['Electrotherapy']}, {'name': 'Pilates', 'type': 'DEVICE', 'description': "Combination of placebo interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient's needs (pragmatic treatment).", 'armGroupLabels': ['Pilates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03071000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Physical Therapy Outpatient Department', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Cidade de Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Cristina Maria Nunes Cabral', 'investigatorAffiliation': 'Universidade Cidade de Sao Paulo'}}}}