Individualized Chiropractic and Integrative Care for Low Back Pain

Sub-Acute and Chronic Low Back Pain Clinical Trial

Official title:

Individualized Chiropractic and Integrative Care for Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567333
• Other study ID #: R18HP07639
• Secondary ID: R18HP07639
• Status: Completed
• Phase: N/A
• First received: December 3, 2007
• Last updated: May 9, 2015
• Start date: June 2007
• Est. completion date: December 2013

Study information

• Verified date: May 2015
• Source: Northwestern Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: December 2013
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• 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.
• 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.

Locations

Country	Name	City	State
United States	Northwestern Health Sciences University	Bloomington	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern Health Sciences University	Berman Center for Outcomes and Clinical Research, Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-rated back pain.		Short term: 12 weeks, Long term: 52 weeks	No
Secondary	Frequency of Symptoms		12 and 52 weeks	No
Secondary	Low Back Disability		12 and 52 weeks	No
Secondary	Fear Avoidance		12 and 52 weeks	No
Secondary	Self-Efficacy		12 and 52 weeks	No
Secondary	General Health Status		12 and 52 weeks	No
Secondary	Improvement		12 and 52 weeks	No
Secondary	Patient Satisfaction		12 and 52 weeks	No
Secondary	Work Loss		12 and 52 weeks	No
Secondary	Medication Use		12 and 52 weeks	No
Secondary	Objective biomechanical measurements: Lumbar Dynamic Motion and Torso Muscle Endurance.		Short term: 12 weeks	No