Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-27 @ 4:05 PM
Study NCT ID:
NCT00567333
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2007-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualized Chiropractic and Integrative Care for Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-09', 'studyFirstSubmitDate': '2007-12-03', 'studyFirstSubmitQcDate': '2007-12-03', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-rated back pain.', 'timeFrame': 'Short term: 12 weeks, Long term: 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Frequency of Symptoms', 'timeFrame': '12 and 52 weeks'}, {'measure': 'Low Back Disability', 'timeFrame': '12 and 52 weeks'}, {'measure': 'Fear Avoidance', 'timeFrame': '12 and 52 weeks'}, {'measure': 'Self-Efficacy', 'timeFrame': '12 and 52 weeks'}, {'measure': 'General Health Status', 'timeFrame': '12 and 52 weeks'}, {'measure': 'Improvement', 'timeFrame': '12 and 52 weeks'}, {'measure': 'Patient Satisfaction', 'timeFrame': '12 and 52 weeks'}, {'measure': 'Work Loss', 'timeFrame': '12 and 52 weeks'}, {'measure': 'Medication Use', 'timeFrame': '12 and 52 weeks'}, {'measure': 'Objective biomechanical measurements: Lumbar Dynamic Motion and Torso Muscle Endurance.', 'timeFrame': 'Short term: 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sub-Acute and Chronic Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '35232482', 'type': 'DERIVED', 'citation': 'Bronfort G, Maiers M, Schulz C, Leininger B, Westrom K, Angstman G, Evans R. Multidisciplinary integrative care versus chiropractic care for low back pain: a randomized clinical trial. Chiropr Man Therap. 2022 Mar 1;30(1):10. doi: 10.1186/s12998-022-00419-3.'}, {'pmid': '21034483', 'type': 'DERIVED', 'citation': 'Maiers MJ, Westrom KK, Legendre CG, Bronfort G. Integrative care for the management of low back pain: use of a clinical care pathway. BMC Health Serv Res. 2010 Oct 29;10:298. doi: 10.1186/1472-6963-10-298.'}, {'pmid': '20210996', 'type': 'DERIVED', 'citation': 'Westrom KK, Maiers MJ, Evans RL, Bronfort G. Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach. Trials. 2010 Mar 8;11:24. doi: 10.1186/1745-6215-11-24.'}]}, 'descriptionModule': {'briefSummary': "This study proposes to compare two innovative treatment approaches for LBP, both of which focus on delivering individualized care through evidence-based, clinical care pathways.\n\nThe primary aim of the project is to determine the relative clinical efficacy of 1) chiropractic care and 2) multidisciplinary, integrative care in 200 patients with sub-acute or chronic LBP, in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome measure in this study is patient-rated back pain.\n\nChiropractic care will include therapies within the professional scope of practice. Integrative, multidisciplinary care will include chiropractic, massage therapy, traditional Chinese medicine (including acupuncture), medication, cognitive behavioral therapy, exercise, and patient education.\n\nSecondary aims are to assess between group differences in frequency of symptoms, disability, fear avoidance behavior, self efficacy, general health, improvement, patient satisfaction, work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and providers' perceptions of treatment will be described using qualitative methods and cost-effectiveness and cost utility will be assessed in the short- and long-term.\n\nThis innovative study is an exciting collaboration between an experienced and established team of chiropractic, conventional, and CAM professionals dedicated to advancing the care of pervasive and costly LBP conditions. This trial will provide new and important information for all health care providers and LBP patients, informing decision making and improving care delivery systems."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mechanical LBP classified as 1, 2, 3, or 4 using Quebec Task Force (QTF) classification.70 (This includes back pain, stiffness or tenderness with or without musculoskeletal and neurological signs).\n* LBP localized to posterior aspect of body, below the costal margin and above the inferior gluteal folds.\n* Pain level \\> 3 on 0 to 10 scale\n* Current LBP episode \\> 6 weeks duration\n* 18 years of age and older\n* Stable prescription medication plan (No changes in prescription medications that affect musculoskeletal pain in the previous month.)\n\nExclusion Criteria:\n\n* Ongoing treatment for LBP by other non-study providers\n* Progressive neurological deficits or cauda equina syndrome\n* QTF classifications 5 (spinal instability or fracture) and 11 (other diagnoses including visceral diseases, compression fractures, metastases). These are serious conditions not amenable to the conservative treatments proposed.\n* QTF 7 (Spinal stenosis syndrome characterized by pain and/or paresthesias in one or both legs aggravated by walking).\n* Uncontrolled hypertension or metabolic disease\n* Blood clotting disorders\n* Severe osteoporosis\n* Inflammatory or destructive tissue changes of the spine\n* Patients with surgical lumbar spine fusion or patients with multiple incidents of lumbar surgery. This is a subgroup of LBP patients which generally have a poorer prognosis.\n* Pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT00567333', 'briefTitle': 'Individualized Chiropractic and Integrative Care for Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern Health Sciences University'}, 'officialTitle': 'Individualized Chiropractic and Integrative Care for Low Back Pain', 'orgStudyIdInfo': {'id': 'R18HP07639'}, 'secondaryIdInfos': [{'id': 'R18HP07639'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'interventionNames': ['Other: Chiropractic care']}, {'type': 'OTHER', 'label': '2', 'interventionNames': ['Other: Multidisciplinary, integrative care']}], 'interventions': [{'name': 'Chiropractic care', 'type': 'OTHER', 'description': 'A combination of professional therapies with the scope of practice, including spinal manipulation therapy, spinal mobilization, stretching and strengthening exercises, and self-care education.', 'armGroupLabels': ['1']}, {'name': 'Multidisciplinary, integrative care', 'type': 'OTHER', 'description': 'A combination of therapies which may include acupuncture/Oriental medicine, chiropractic, cognitive behavioral therapy, exercise therapy, medicine, self-care information, and massage therapy.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55431', 'city': 'Bloomington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Northwestern Health Sciences University', 'geoPoint': {'lat': 44.8408, 'lon': -93.29828}}], 'overallOfficials': [{'name': 'Gert Bronfort, DC, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern Health Sciences University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern Health Sciences University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Resources and Services Administration (HRSA)', 'class': 'FED'}, {'name': 'Berman Center for Outcomes and Clinical Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}