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.

Study Overview

• Status: Completed
• Conditions: Sub-Acute and Chronic Low Back Pain
• Intervention / Treatment: Other: Chiropractic care; Other: Multidisciplinary, integrative care

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • Northwestern Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient-rated back pain.	Short term: 12 weeks, Long term: 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of Symptoms	12 and 52 weeks
Low Back Disability	12 and 52 weeks
Fear Avoidance	12 and 52 weeks
Self-Efficacy	12 and 52 weeks
General Health Status	12 and 52 weeks
Improvement	12 and 52 weeks
Patient Satisfaction	12 and 52 weeks
Work Loss	12 and 52 weeks
Medication Use	12 and 52 weeks
Objective biomechanical measurements: Lumbar Dynamic Motion and Torso Muscle Endurance.	Short term: 12 weeks

Collaborators and Investigators

• Sponsor: Northwestern Health Sciences University
• Collaborators: Health Resources and Services Administration (HRSA); Berman Center for Outcomes and Clinical Research

Publications and helpful links

General Publications

• Bronfort G, Maiers M, Schulz C, Leininger B, Westrom K, Angstman G, Evans R. Multidisciplinary integrative care versus chiropractic care for low back pain: a randomized clinical trial. Chiropr Man Therap. 2022 Mar 1;30(1):10. doi: 10.1186/s12998-022-00419-3.
• Maiers MJ, Westrom KK, Legendre CG, Bronfort G. Integrative care for the management of low back pain: use of a clinical care pathway. BMC Health Serv Res. 2010 Oct 29;10:298. doi: 10.1186/1472-6963-10-298.
• Westrom KK, Maiers MJ, Evans RL, Bronfort G. Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach. Trials. 2010 Mar 8;11:24. doi: 10.1186/1745-6215-11-24.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (ACTUAL): October 1, 2010
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: December 3, 2007
• First Submitted That Met QC Criteria: December 3, 2007
• First Posted (ESTIMATE): December 4, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 9, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: R18HP07639