Skip to main content
OpenTrials
Completed

NCT Number: NCT00567333

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sub-Acute and Chronic Low Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Health Sciences University

Bloomington, Minnesota, 55431, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chiropractic care

Other

A combination of professional therapies with the scope of practice, including spinal manipulation therapy, spinal mobilization, stretching and strengthening exercises, and self-care education.

Multidisciplinary, integrative care

Other

A combination of therapies which may include acupuncture/Oriental medicine, chiropractic, cognitive behavioral therapy, exercise therapy, medicine, self-care information, and massage therapy.

Primary outcomes

  1. Patient-rated back pain.

    Time frame: Short term: 12 weeks, Long term: 52 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Northwestern Health Sciences University

Other

Collaborators

  • Berman Center for Outcomes and Clinical Research
  • Health Resources and Services Administration (HRSA)

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2013
First posted
Dec 4, 2007
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.