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Individualized Chiropractic and Integrative Care for Low Back Pain

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ClinicalTrials.gov Identifier: NCT00567333
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : May 12, 2015
Health Resources and Services Administration (HRSA)
Berman Center for Outcomes and Clinical Research
Information provided by (Responsible Party):
Northwestern Health Sciences University

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
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 1
    Intervention: Other: Chiropractic care
  • 2
    Intervention: Other: Multidisciplinary, integrative care
Publications *

*   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)
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2007)
Actual Study Completion Date  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Northwestern Health Sciences University
Original Responsible Party Gert Bronfort DC, PhD, Northwestern Health Sciences University
Current Study Sponsor  ICMJE Northwestern Health Sciences University
Original Study Sponsor  ICMJE Same as current
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