Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT00922220
Status:
COMPLETED
Last Update Posted:
2011-12-22
First Post:
2009-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of a Potential Mechanisms of Spinal Manipulation in the Treatment of 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020393', 'term': 'Manipulation, Spinal'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000529', 'term': 'Complementary Therapies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-21', 'studyFirstSubmitDate': '2009-06-15', 'studyFirstSubmitQcDate': '2009-06-16', 'lastUpdatePostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Rating Scale', 'timeFrame': 'Prior to and immediately following assigned intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['low back pain', 'spinal manipulation', 'central sensitization', 'manual therapy'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '16911795', 'type': 'RESULT', 'citation': 'George SZ, Bishop MD, Bialosky JE, Zeppieri G Jr, Robinson ME. Immediate effects of spinal manipulation on thermal pain sensitivity: an experimental study. BMC Musculoskelet Disord. 2006 Aug 15;7:68. doi: 10.1186/1471-2474-7-68.'}, {'pmid': '19797305', 'type': 'RESULT', 'citation': 'Bialosky JE, Bishop MD, Robinson ME, Zeppieri G Jr, George SZ. Spinal manipulative therapy has an immediate effect on thermal pain sensitivity in people with low back pain: a randomized controlled trial. Phys Ther. 2009 Dec;89(12):1292-303. doi: 10.2522/ptj.20090058. Epub 2009 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the immediate effect of 3 common physical therapy interventions for people experiencing low back pain on the perception of thermal pain. Additionally, the investigators wished to determine the influence of psychological factors related to fear and anxiety on their findings and to determine whether the effects of the individual interventions were local (specific to the area of application) or global (influenced regions away from the area of application).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages eighteen to sixty\n* currently experiencing low back pain OR currently not experiencing low back pain and have not had an episode for the prior six months\n\nExclusion Criteria:\n\n* non-English speaking\n* systemic medical conditions (e.g. diabetes, hypertension)\n* current use of psychiatric medication\n* pregnancy\n* signs and symptoms indicative of nerve root compression (reflex change, myotomal weakness, or sensation change)\n* history of surgery to the low back'}, 'identificationModule': {'nctId': 'NCT00922220', 'briefTitle': 'A Study of a Potential Mechanisms of Spinal Manipulation in the Treatment of Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Immediate Effect of Physical Interventions for Low Back Pain', 'orgStudyIdInfo': {'id': '343-2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'stationary bike', 'description': 'Participants rode a stationary bike for five minutes', 'interventionNames': ['Other: stationary bike']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lumbar extension exercises', 'description': 'Participants performed four sets of fifteen lumbar extension exercises over five minutes', 'interventionNames': ['Other: lumbar extension exercise']}, {'type': 'EXPERIMENTAL', 'label': 'spinal manipulative therapy', 'description': 'Participants received spinal manipulative therapy to the low back', 'interventionNames': ['Other: spinal manipulative therapy']}], 'interventions': [{'name': 'stationary bike', 'type': 'OTHER', 'description': 'Participants rode a stationary bike for five minutes', 'armGroupLabels': ['stationary bike']}, {'name': 'lumbar extension exercise', 'type': 'OTHER', 'otherNames': ['press up'], 'description': 'Participants performed four sets of fifteen lumbar extension exercises over fifteen minutes', 'armGroupLabels': ['lumbar extension exercises']}, {'name': 'spinal manipulative therapy', 'type': 'OTHER', 'otherNames': ['spinal manipulation', 'manual therapy'], 'description': 'participants received spinal manipulative therapy to the low back', 'armGroupLabels': ['spinal manipulative therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Steven Z George, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida Department of Physical Therapy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}