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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

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.

Condition or disease Intervention/treatment Phase
Sub-Acute and Chronic Low Back Pain Other: Chiropractic care Other: Multidisciplinary, integrative care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Individualized Chiropractic and Integrative Care for Low Back Pain
Study Start Date : June 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2013

Arm Intervention/treatment
1 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.

2 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.

Primary Outcome Measures :
  1. Patient-rated back pain. [ Time Frame: Short term: 12 weeks, Long term: 52 weeks ]

Secondary Outcome Measures :
  1. Frequency of Symptoms [ Time Frame: 12 and 52 weeks ]
  2. Low Back Disability [ Time Frame: 12 and 52 weeks ]
  3. Fear Avoidance [ Time Frame: 12 and 52 weeks ]
  4. Self-Efficacy [ Time Frame: 12 and 52 weeks ]
  5. General Health Status [ Time Frame: 12 and 52 weeks ]
  6. Improvement [ Time Frame: 12 and 52 weeks ]
  7. Patient Satisfaction [ Time Frame: 12 and 52 weeks ]
  8. Work Loss [ Time Frame: 12 and 52 weeks ]
  9. Medication Use [ Time Frame: 12 and 52 weeks ]
  10. Objective biomechanical measurements: Lumbar Dynamic Motion and Torso Muscle Endurance. [ Time Frame: Short term: 12 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567333

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United States, Minnesota
Northwestern Health Sciences University
Bloomington, Minnesota, United States, 55431
Sponsors and Collaborators
Northwestern Health Sciences University
Health Resources and Services Administration (HRSA)
Berman Center for Outcomes and Clinical Research
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Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Northwestern Health Sciences University
ClinicalTrials.gov Identifier: NCT00567333    
Other Study ID Numbers: R18HP07639
First Posted: December 4, 2007    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations