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Individualized Chiropractic and Integrative Care for Low Back Pain
This study is currently recruiting participants.
Study NCT00567333   Information provided by Northwestern Health Sciences University
First Received: December 3, 2007   Last Updated: February 3, 2009   History of Changes

December 3, 2007
February 3, 2009
June 2007
August 2009   (final data collection date for primary outcome measure)
Patient-rated back pain. [ Time Frame: Short term: 12 weeks, Long term: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00567333 on ClinicalTrials.gov Archive Site
  • Frequency of Symptoms [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Low Back Disability [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Fear Avoidance [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Self-Efficacy [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: No ]
  • General Health Status [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Improvement [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Work Loss [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Medication Use [ Time Frame: 12 and 52 weeks ] [ Designated as safety issue: No ]
  • Objective biomechanical measurements: Lumbar Dynamic Motion and Torso Muscle Endurance. [ Time Frame: Short term: 12 weeks ] [ Designated as safety issue: No ]
Same as current
 
Individualized Chiropractic and Integrative Care for Low Back Pain
Individualized Chiropractic and Integrative Care for Low Back Pain

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.

 
 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Sub-Acute and Chronic Low Back Pain
  • Other: Chiropractic care
  • Other: Multidisciplinary, integrative care
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
June 2010
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
 
United States
 
NCT00567333
Gert Bronfort DC, PhD, Northwestern Health Sciences University
R18HP07639, R18HP07639
Northwestern Health Sciences University
  • Health Resources and Services Administration (HRSA)
  • Berman Center for Outcomes and Clinical Research
Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
Northwestern Health Sciences University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP