Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-04 @ 9:05 PM
Study NCT ID:
NCT02210520
Status:
UNKNOWN
Last Update Posted:
2014-08-06
First Post:
2014-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Ultrasound and Laser in Chronic Low Back Pain: Randomized Double-blinded Controled Trial
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': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-04', 'studyFirstSubmitDate': '2014-07-11', 'studyFirstSubmitQcDate': '2014-08-04', 'lastUpdatePostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '4 weeks', 'description': 'Visual Analog Scale'}], 'secondaryOutcomes': [{'measure': 'Pain quality', 'timeFrame': '4 weeks', 'description': 'McGill questionaire'}, {'measure': 'Disability', 'timeFrame': '4 Weeks', 'description': 'Roland Morris Questionaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The low level laser therapy has a better effect in decrease the pain than ultrasound therapeutic.', 'detailedDescription': 'The laser will be applied with the dosimetry 3 J/cm², 2 minutes in 6 points around the back spine, during 4 weeks. Before the women will be evaluate again.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic low back pain\n* 3,0 - 7,0 in the visual analogic scale\n\nExclusion Criteria:\n\n* no use of medications\n* no other treatment\n* without fractures, pregnancy, psychiatric or neurologic disorders, diabetes, amputations\n* with diagnostic of low back pain'}, 'identificationModule': {'nctId': 'NCT02210520', 'briefTitle': 'Effect of Ultrasound and Laser in Chronic Low Back Pain: Randomized Double-blinded Controled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Effect of Laser and Ultrasound in Pain and Disability in Women With Chronic Non-specific Low Back Pain: Randomized Double-blinded Controled Trial', 'orgStudyIdInfo': {'id': 'São Lucas College'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'laser', 'description': '3 J/cm², 2 minutes in 6 points around the back spine', 'interventionNames': ['Device: pulsatile ultrasound', 'Device: continuous ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'pulsatile ultrasound', 'description': '1 W/cm², 2 minutes in 6 points around the back spine', 'interventionNames': ['Device: continuous ultrasound', 'Device: laser']}, {'type': 'EXPERIMENTAL', 'label': 'continuous ultrasound', 'description': '1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.', 'interventionNames': ['Device: pulsatile ultrasound', 'Device: laser']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'no treatment.'}], 'interventions': [{'name': 'pulsatile ultrasound', 'type': 'DEVICE', 'description': '1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.', 'armGroupLabels': ['continuous ultrasound', 'laser']}, {'name': 'continuous ultrasound', 'type': 'DEVICE', 'description': '1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.', 'armGroupLabels': ['laser', 'pulsatile ultrasound']}, {'name': 'laser', 'type': 'DEVICE', 'description': '1 W/cm², 2 minutes in 6 points around the back spine', 'armGroupLabels': ['continuous ultrasound', 'pulsatile ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76800000', 'city': 'Porto Velho', 'state': 'Rondõnia', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Ana Paula A Rubira, Master', 'role': 'CONTACT', 'email': 'anapaularubira@hotmail.com', 'phone': '55 069 3211-8082'}, {'name': 'Ana Paula A Rubira, master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'São Lucas College', 'geoPoint': {'lat': -8.76194, 'lon': -63.90389}}], 'overallOfficials': [{'name': 'Ana Paula A Rubira, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'São Paulo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master', 'investigatorFullName': 'Ana Paula Fernandes A. Rubira', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}