Individualized Chiropractic and Integrative Care for Low Back Pain

Tracking Information
First Submitted Date ICMJE	December 3, 2007
First Posted Date ICMJE	December 4, 2007
Last Update Posted Date	May 12, 2015
Study Start Date ICMJE	June 2007
Actual Primary Completion Date	October 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 3, 2007)	Patient-rated back pain. [ Time Frame: Short term: 12 weeks, Long term: 52 weeks ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00567333 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 3, 2007)	Frequency of Symptoms [ Time Frame: 12 and 52 weeks ]; Low Back Disability [ Time Frame: 12 and 52 weeks ]; Fear Avoidance [ Time Frame: 12 and 52 weeks ]; Self-Efficacy [ Time Frame: 12 and 52 weeks ]; General Health Status [ Time Frame: 12 and 52 weeks ]; Improvement [ Time Frame: 12 and 52 weeks ]; Patient Satisfaction [ Time Frame: 12 and 52 weeks ]; Work Loss [ Time Frame: 12 and 52 weeks ]; Medication Use [ Time Frame: 12 and 52 weeks ]; Objective biomechanical measurements: Lumbar Dynamic Motion and Torso Muscle Endurance. [ Time Frame: Short term: 12 weeks ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Individualized Chiropractic and Integrative Care for Low Back Pain
Official Title ICMJE	Individualized Chiropractic and Integrative Care for Low Back Pain
Brief Summary	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. The 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. Chiropractic 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. Secondary 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. This 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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Sub-Acute and Chronic Low Back Pain
Intervention ICMJE	Other: Chiropractic care A combination of professional therapies with the scope of practice, including spinal manipulation therapy, spinal mobilization, stretching and strengthening exercises, and self-care education.; Other: Multidisciplinary, integrative care A combination of therapies which may include acupuncture/Oriental medicine, chiropractic, cognitive behavioral therapy, exercise therapy, medicine, self-care information, and massage therapy.
Study Arms	1 Intervention: Other: Chiropractic care; 2 Intervention: Other: Multidisciplinary, integrative care
Publications *	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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 9, 2015)	201
Original Estimated Enrollment ICMJE; (submitted: December 3, 2007)	200
Actual Study Completion Date	December 2013
Actual Primary Completion Date	October 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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).; LBP localized to posterior aspect of body, below the costal margin and above the inferior gluteal folds.; Pain level > 3 on 0 to 10 scale; Current LBP episode > 6 weeks duration; 18 years of age and older; Stable prescription medication plan (No changes in prescription medications that affect musculoskeletal pain in the previous month.) Exclusion Criteria: Ongoing treatment for LBP by other non-study providers; Progressive neurological deficits or cauda equina syndrome; 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.; QTF 7 (Spinal stenosis syndrome characterized by pain and/or paresthesias in one or both legs aggravated by walking).; Uncontrolled hypertension or metabolic disease; Blood clotting disorders; Severe osteoporosis; Inflammatory or destructive tissue changes of the spine; 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.; Pregnant or nursing women
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00567333
Other Study ID Numbers ICMJE	R18HP07639; R18HP07639
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Northwestern Health Sciences University
Study Sponsor ICMJE	Northwestern Health Sciences University
Collaborators ICMJE	Health Resources and Services Administration (HRSA); Berman Center for Outcomes and Clinical Research
Investigators ICMJE	Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
PRS Account	Northwestern Health Sciences University
Verification Date	May 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP