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Trial record 1 of 2 for:    individualized chiropractic integrative back pain
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Individualized Chiropractic and Integrative Care for Low Back Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Health Resources and Services Administration (HRSA)
Berman Center for Outcomes and Clinical Research
Information provided by (Responsible Party):
Northwestern Health Sciences University
ClinicalTrials.gov Identifier:
NCT00567333
First received: December 3, 2007
Last updated: August 12, 2013
Last verified: August 2013

December 3, 2007
August 12, 2013
June 2007
October 2010   (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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Sub-Acute and Chronic Low Back Pain
  • 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.
  • 1
    Intervention: Other: Chiropractic care
  • 2
    Intervention: Other: Multidisciplinary, integrative care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2013
October 2010   (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
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00567333
R18HP07639, R18HP07639
Yes
Northwestern Health Sciences University
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
August 2013

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