Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-28 @ 9:21 AM
Study NCT ID:
NCT02123693
Status:
UNKNOWN
Last Update Posted:
2014-09-16
First Post:
2014-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Osteopathic Treatment in the Axial Variations of the Lumbar Spine: RCT
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': 'D026301', 'term': 'Manipulation, Osteopathic'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-15', 'studyFirstSubmitDate': '2014-04-24', 'studyFirstSubmitQcDate': '2014-04-24', 'lastUpdatePostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline changes in degree of flection of lumbar spine', 'timeFrame': 'at entry and after 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Baseline changes in Visual Analogue Scale', 'timeFrame': 'at entry and after 8 weeks'}, {'measure': 'Baseline changes in Roland-Morris questionnaire', 'timeFrame': 'at entry and after 8 weeks'}]}, 'conditionsModule': {'keywords': ['Osteopathic manipulative treatment', 'Low back pain', 'Dynamic MRI'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to determine whether there is a relationship between osteopathic treatment and the change of physiological axes of the lumbar spine, through the use of Dynamic Magnetic Resonance Imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* will be admitted patients of both genders\n* patients with chronic low back pain at baseline\n* patients aged between 18 and 35 years\n\nExclusion Criteria:\n\n* patients diagnosed with the disease of the musculoskeletal system or congenital malformation of the column\n* patients with disorders of the pelvic floor, or who have undergone surgery of the reproductive system\n* patients with neurological disorders that can cause painful symptoms of lumbar segment'}, 'identificationModule': {'nctId': 'NCT02123693', 'briefTitle': 'The Role of Osteopathic Treatment in the Axial Variations of the Lumbar Spine: RCT', 'organization': {'class': 'OTHER', 'fullName': 'European Institute for Evidence Based Osteopathic Medicine'}, 'orgStudyIdInfo': {'id': 'DYNOST-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Osteopathic Manipulative Treatment', 'description': '5 sessions of treatment will be carried out: the first 3 weekly, and the remaining 2 after 15 days. The type of treatment will be based on indirect techniques', 'interventionNames': ['Other: Osteopathic manipulative treatment']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham therapy', 'description': '5 sessions of treatment will be carried out: the first 3 weekly, and the remaining 2 after 15 days. The type of treatment will be based on specific parameters set out previously based on a predetermined protocol', 'interventionNames': ['Other: Sham Therapy']}, {'type': 'OTHER', 'label': 'No intervention', 'description': 'Patients in this group will not receive any type of intervention, both therapeutic than fictitious, and will not be evaluated by any operator', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'Osteopathic manipulative treatment', 'type': 'OTHER', 'armGroupLabels': ['Osteopathic Manipulative Treatment']}, {'name': 'Sham Therapy', 'type': 'OTHER', 'armGroupLabels': ['Sham therapy']}, {'name': 'No Intervention', 'type': 'OTHER', 'armGroupLabels': ['No intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67100', 'city': 'L’Aquila', 'state': 'Abruzzo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Cicchitti, DO', 'role': 'CONTACT', 'email': 'cicchittiluca@gmail.com', 'phone': '3925263387'}, {'name': 'Luca Cicchitti, DO', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Radiology Unit II, University Hospital San Salvatore L'Aquila", 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute for Evidence Based Osteopathic Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}