Individualized Chiropractic and Integrative Care for Low Back Pain - Full Text View

Sponsor:	Northwestern Health Sciences University
Collaborators:	Health Resources and Services Administration (HRSA) Berman Center for Outcomes and Clinical Research
Information provided by:	Northwestern Health Sciences University
ClinicalTrials.gov Identifier:	NCT00567333

Purpose

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	Intervention
Sub-Acute and Chronic Low Back Pain	Other: Chiropractic care Other: Multidisciplinary, integrative care

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Individualized Chiropractic and Integrative Care for Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by Northwestern Health Sciences University:

Primary Outcome Measures:

Patient-rated back pain. [ Time Frame: Short term: 12 weeks, Long term: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567333

Locations

United States, Minnesota
Northwestern Health Sciences University	Recruiting
Bloomington, Minnesota, United States, 55431
Contact: Kristine K. Westrom, MD 952-888-4777 ext 369 kwestrom@nwhealth.edu
Contact: Claire Legendre (952) 888-4777 ext 293 clegendre@nwhealth.edu
Principal Investigator: Gert Bronfort, DC, PhD

Sponsors and Collaborators

Northwestern Health Sciences University

Health Resources and Services Administration (HRSA)

Berman Center for Outcomes and Clinical Research

Investigators

Principal Investigator:

Gert Bronfort, DC, PhD

Northwestern Health Sciences University

More Information

No publications provided

Responsible Party:	Northwestern Health Sciences University ( Gert Bronfort DC, PhD )
Study ID Numbers:	R18HP07639, R18HP07639
Study First Received:	December 3, 2007
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00567333 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations

Low Back Pain
Pain
Back Pain

ClinicalTrials.gov processed this record on November 25, 2009