Individualized Chiropractic and Integrative Care for Low Back Pain

Not Applicable

Completed

• Conditions: Sub-Acute and Chronic Low Back Pain
• Interventions: Other: Chiropractic care; Other: Multidisciplinary, integrative care

• Registration Number: NCT00567333
• Lead Sponsor: Northwestern Health Sciences University

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 available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-04
• Primary Completion: 2010-10
• Study Completion: 2013-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-09
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Chiropractic care	-
2	Multidisciplinary, integrative care	-

Primary Outcome Measures

Name	Time	Method
Patient-rated back pain.	Short term: 12 weeks, Long term: 52 weeks

Secondary Outcome Measures

Name	Time	Method
Objective biomechanical measurements: Lumbar Dynamic Motion and Torso Muscle Endurance.	Short term: 12 weeks
Frequency of Symptoms	12 and 52 weeks
Low Back Disability	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
Fear Avoidance	12 and 52 weeks

Trial Locations

Locations (1)

Northwestern Health Sciences University; 🇺🇸 Bloomington, Minnesota, United States