Individualized Chiropractic and Integrative Care for Low Back Pain

• ClinicalTrials.gov Identifier: NCT00567333
• Recruitment Status: Completed
• First Posted: December 4, 2007
• Last Update Posted: May 12, 2015
• Sponsor: Northwestern Health Sciences University
• Collaborators: Health Resources and Services Administration (HRSA); Berman Center for Outcomes and Clinical Research
• Information provided by (Responsible Party): Northwestern Health Sciences University

Tracking Information

• First Submitted Date: December 3, 2007
• First Posted Date: December 4, 2007
• Last Update Posted Date: May 12, 2015
• Study Start Date: June 2007
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 3, 2007): Patient-rated back pain. [ Time Frame: Short term: 12 weeks, Long term: 52 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 3, 2007)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Individualized Chiropractic and Integrative Care for Low Back Pain
• Official Title: Individualized Chiropractic and Integrative Care for Low Back Pain

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Sub-Acute and Chronic Low Back Pain

Intervention

• 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.

Study Arms

• 1
  Intervention: Other: Chiropractic care
• 2
  Intervention: Other: Multidisciplinary, integrative care

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 9, 2015): 201
• Original Estimated Enrollment (submitted: December 3, 2007): 200
• Actual Study Completion Date: December 2013
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00567333
• Other Study ID Numbers: R18HP07639; R18HP07639
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Northwestern Health Sciences University
• Original Responsible Party: Gert Bronfort DC, PhD, Northwestern Health Sciences University
• Current Study Sponsor: Northwestern Health Sciences University
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Principal Investigator: Gert Bronfort, DC, PhD; Northwestern Health Sciences University

• PRS Account: Northwestern Health Sciences University
• Verification Date: May 2015