Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-12 @ 10:06 PM
Study NCT ID:
NCT02815358
Status:
COMPLETED
Last Update Posted:
2019-06-13
First Post:
2016-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Segmental Stabilization on the Anticipatory Postural Adjustment of Subjects With Lumbar 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-12', 'studyFirstSubmitDate': '2016-06-22', 'studyFirstSubmitQcDate': '2016-06-23', 'lastUpdatePostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anticipatory Postural Adjustment by means of Electromyography', 'timeFrame': 'change from pre to post-treatment (8 weeks)', 'description': 'Assessed by means of superficial electromyography'}], 'secondaryOutcomes': [{'measure': 'Disability level via the Oswestry Low Back Pain Questionnaire', 'timeFrame': 'change from pre to post-treatment (8 weeks)'}, {'measure': 'Fear of pain and avoidance of physical activity via the Fear-avoidance beliefs Questionnaire', 'timeFrame': 'change from pre to post-treatment (8 weeks)'}, {'measure': 'Prognosis or risk of poor clinical outcome via the STarT Back Screening Tool', 'timeFrame': 'change from pre to post-treatment (8 weeks)'}, {'measure': 'Pain level via visual analogue scale', 'timeFrame': 'change from pre to post-treatment (8 weeks)'}]}, 'conditionsModule': {'conditions': ['Lumbar Pain']}, 'descriptionModule': {'briefSummary': 'This study aims to verify the effects of a segmental stabilization exercise program on the anticipatory postural adjustment of subjects with chronic lumbar pain. The effects will be assessed by means of superficial electromyography focused on the registry of the onset of multifidius and deltoid (anterior and posterior) activity during a repetitive shoulder flexion/extension.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women aged between 18 and 65 years old\n* chronic lumbar pain (at least 3 months)\n* average pain intensity of ≥3 on a 10-point scale\n\nExclusion Criteria:\n\n* presence of red flags (i.e.,tumor, known fractures, diagnosed inflammatory joint disease, etc);\n* history of back surgery\n* pregnancy\n* less than 3 months of therapeutic treatment (physiotherapy) for low back pain'}, 'identificationModule': {'nctId': 'NCT02815358', 'briefTitle': 'Effects of Segmental Stabilization on the Anticipatory Postural Adjustment of Subjects With Lumbar Pain', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Health Science of Porto Alegre'}, 'orgStudyIdInfo': {'id': '923.642'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Segmental Stabilization Group', 'description': 'Patients receiving segmental stabilization exercises.', 'interventionNames': ['Other: Segmental Stabilization Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Patients receiving home exercises.', 'interventionNames': ['Other: Home Exercises']}], 'interventions': [{'name': 'Segmental Stabilization Exercises', 'type': 'OTHER', 'description': 'The stabilization program focuses on the reestablishment of motor control and coordination between deep and superficial trunk muscles. The exercise program is based on the following criteria progression: 1) Precise contraction of the transverse abdominal and multifidus muscles, keeping the lumbar spine in a neutral position (as the middle way between maximum flexion and extension, repeated three times); 2) Keep the neutral position for 10 repetitions of 10 seconds; 3) Perform exercises with lower limbs in different postures.', 'armGroupLabels': ['Segmental Stabilization Group']}, {'name': 'Home Exercises', 'type': 'OTHER', 'description': 'Home exercises include passive stretching and active mobilization of the spine.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Federal University of Health Sciences of Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Health Science of Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Aline de Souza Pagnussat', 'investigatorAffiliation': 'Federal University of Health Science of Porto Alegre'}}}}