Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-02-10 @ 8:41 AM
Study NCT ID:
NCT02714803
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2016-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Different Massage Techniques Plus Conservative Applications in Low Back 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-16', 'studyFirstSubmitDate': '2016-03-12', 'studyFirstSubmitQcDate': '2016-03-16', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in low back pain intensity as measured by Visual Analog Scale', 'timeFrame': 'Change from baseline low back pain intensity at 2 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in quality of life as assessed by Short Form-36', 'timeFrame': 'Change from baseline quality of life at 2 weeks'}, {'measure': 'Change in functional statue as assessed by Oswestry Disability Index', 'timeFrame': 'Change from baseline functional statue at 2 weeks'}, {'measure': 'Change in psychologic statue as assessed by Hospital Anxiety and Depression Scale', 'timeFrame': 'Change from baseline psychologic statue at 2 weeks'}]}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare of different massage techniques plus conservative aplications in low back pain treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having non specific low back pain without any relevant ongoing pathologies such as disc prolapse, spondylolisthesis, fractures, tumor, osteoporosis, infection\n* Willing to participate\n\nExclusion Criteria:\n\n* Spinal surgery in the past 6 months or having to undergo surgery or invasive examinations during the study;\n* neurological disease;\n* psychiatric disease;\n* serious chronic disease that could interfere with the outcomes (e.g., cardiovascular disease, epilepsy, rheumatoid arthritis),\n* pregnant during the study'}, 'identificationModule': {'nctId': 'NCT02714803', 'briefTitle': 'Comparison of Different Massage Techniques Plus Conservative Applications in Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk Training and Research Hospital'}, 'officialTitle': 'Assistant Professor', 'orgStudyIdInfo': {'id': '2015-11/33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Connective tissue massage group', 'description': 'Connective tissue massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied', 'interventionNames': ['Behavioral: "Connective tissue massage" and "Conservative applications"']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Classic massage group', 'description': 'Classic massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied', 'interventionNames': ['Behavioral: "Classic massage group" and "Conservative applications"']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham massage group', 'description': 'Sham massage plus conservative applications including superficial thermal, electrotherapy and home exercise program were applied', 'interventionNames': ['Behavioral: "Sham massage group" and "Conservative applications"']}], 'interventions': [{'name': '"Connective tissue massage" and "Conservative applications"', 'type': 'BEHAVIORAL', 'description': 'Connective tissue massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.', 'armGroupLabels': ['Connective tissue massage group']}, {'name': '"Classic massage group" and "Conservative applications"', 'type': 'BEHAVIORAL', 'description': 'Classic massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.', 'armGroupLabels': ['Classic massage group']}, {'name': '"Sham massage group" and "Conservative applications"', 'type': 'BEHAVIORAL', 'description': 'Sham massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.', 'armGroupLabels': ['Sham massage group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'Cankaya', 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Seyda TOPRAK CELENAY', 'investigatorAffiliation': 'Ataturk Training and Research Hospital'}}}}