Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
Study NCT ID:
NCT00376350
Status:
COMPLETED
Last Update Posted:
2015-08-24
First Post:
2006-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose of Spinal Manipulation for Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], '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'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020393', 'term': 'Manipulation, Spinal'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-21', 'studyFirstSubmitDate': '2006-09-12', 'studyFirstSubmitQcDate': '2006-09-12', 'lastUpdatePostDateStruct': {'date': '2015-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Von Korff Pain Scale for low back pain', 'timeFrame': 'baseline 1&2, 6, 12, 18, 24, 39, 52 weeks'}, {'measure': 'Modified Von Korff Disability Scale', 'timeFrame': 'baseline 1&2, 6, 12, 18, 24, 39, 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Pain days', 'timeFrame': 'baseline 1&2, 6, 12, 18, 24, 39, 52 weeks'}, {'measure': 'Disability days', 'timeFrame': 'baseline 1&2, 6, 12, 18, 24, 39, 52 weeks'}, {'measure': 'Low back pain unpleasantness', 'timeFrame': 'baseline 2, 6, 12, 18, 24, 39, 52 weeks'}, {'measure': 'Fear avoidance beliefs', 'timeFrame': 'baseline 2, 6, 12, 18, 24, 39, 52 weeks'}, {'measure': 'General health status/QoL', 'timeFrame': 'baseline 2; 12, 24, 39, 52 weeks'}, {'measure': 'Patient satisfaction', 'timeFrame': '12 wk'}, {'measure': 'Healthcare utilization', 'timeFrame': 'baseline 2; 6, 12, 18, 24, 39, 52 weeks'}, {'measure': 'Objective measures', 'timeFrame': 'Baseline 2, 6 wk'}, {'measure': 'Bias monitoring', 'timeFrame': 'baseline 1&2; 6, 12, 18, 24, 39, 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Low Back Pain', 'Chronic', 'Manipulation', 'Chiropractic', 'Massage'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '15363431', 'type': 'BACKGROUND', 'citation': 'Haas M, Groupp E, Kraemer DF. Dose-response for chiropractic care of chronic low back pain. Spine J. 2004 Sep-Oct;4(5):574-83. doi: 10.1016/j.spinee.2004.02.008.'}, {'pmid': '24139233', 'type': 'RESULT', 'citation': 'Haas M, Vavrek D, Peterson D, Polissar N, Neradilek MB. Dose-response and efficacy of spinal manipulation for care of chronic low back pain: a randomized controlled trial. Spine J. 2014 Jul 1;14(7):1106-16. doi: 10.1016/j.spinee.2013.07.468. Epub 2013 Oct 16.'}, {'pmid': '24410959', 'type': 'RESULT', 'citation': 'Haas M, Vavrek D, Neradilek MB, Polissar N. A path analysis of the effects of the doctor-patient encounter and expectancy in an open-label randomized trial of spinal manipulation for the care of low back pain. BMC Complement Altern Med. 2014 Jan 13;14:16. doi: 10.1186/1472-6882-14-16.'}, {'pmid': '26286532', 'type': 'RESULT', 'citation': 'Vavrek D, Haas M, Neradilek MB, Polissar N. Prediction of pain outcomes in a randomized controlled trial of dose-response of spinal manipulation for the care of chronic low back pain. BMC Musculoskelet Disord. 2015 Aug 19;16:205. doi: 10.1186/s12891-015-0632-0.'}, {'pmid': '24928639', 'type': 'RESULT', 'citation': 'Vavrek DA, Sharma R, Haas M. Cost analysis related to dose-response of spinal manipulative therapy for chronic low back pain: outcomes from a randomized controlled trial. J Manipulative Physiol Ther. 2014 Jun;37(5):300-11. doi: 10.1016/j.jmpt.2014.03.002.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. The study will also determine the effectiveness of spinal manipulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current episode of low back pain\n* mechanical origin\n* Threshold low back pain level\n\nExclusion Criteria:\n\n* Contraindications to spinal manipulation or massage\n* Complicating conditions that could confound clinical outcome\n* Prophylactic use of prescription medication\n* Health-related litigation, claims, or disability compensation'}, 'identificationModule': {'nctId': 'NCT00376350', 'briefTitle': 'Dose of Spinal Manipulation for Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Western States'}, 'officialTitle': 'Dose-Response/Efficacy of Manipulation for Chronic LBP', 'orgStudyIdInfo': {'id': 'U01AT001908', 'link': 'https://reporter.nih.gov/quickSearch/U01AT001908', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'U01AT001908', 'link': 'https://reporter.nih.gov/quickSearch/U01AT001908', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High dose manipulation', 'description': 'High dose spinal manipulation + ultrasound', 'interventionNames': ['Procedure: Spinal Manipulation', 'Procedure: Pulsed Ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate dose manipulation', 'description': 'Moderate dose manipulation + low dose massage + ultrasound', 'interventionNames': ['Procedure: Spinal Manipulation', 'Procedure: Light Massage', 'Procedure: Pulsed Ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose manipulation', 'description': 'low dose spinal manipulation + moderate dose massage + ultrasound', 'interventionNames': ['Procedure: Spinal Manipulation', 'Procedure: Light Massage', 'Procedure: Pulsed Ultrasound']}, {'type': 'OTHER', 'label': 'High dose masssage', 'description': 'high dose massage + ultrasound', 'interventionNames': ['Procedure: Light Massage', 'Procedure: Pulsed Ultrasound']}], 'interventions': [{'name': 'Spinal Manipulation', 'type': 'PROCEDURE', 'description': '5 minutes high velocity, low amplitude lumbar thrust', 'armGroupLabels': ['High dose manipulation', 'Low dose manipulation', 'Moderate dose manipulation']}, {'name': 'Light Massage', 'type': 'PROCEDURE', 'description': 'light pressure massage of the low back.', 'armGroupLabels': ['High dose masssage', 'Low dose manipulation', 'Moderate dose manipulation']}, {'name': 'Pulsed Ultrasound', 'type': 'PROCEDURE', 'description': '5 minutes pulsed ultrasound', 'armGroupLabels': ['High dose manipulation', 'High dose masssage', 'Low dose manipulation', 'Moderate dose manipulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97230', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Western States Chiropractic College', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Mitchell Haas, DC, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Western States'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Western States', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Vice President of Research', 'investigatorFullName': 'Mitchell Haas', 'investigatorAffiliation': 'University of Western States'}}}}