Individualized Chiropractic and Integrative Care for Low... | NCT00567333

Studies
Individualized Chiropractic and Integrative Care for Low Back Pain

NCT00567333

Sponsor

Northwestern Health Sciences University

Status

Completed

Last Update Posted

May 12, 2015Estimated

Enrollment

201Actual

Phase

Not Applicable

Conditions

Sub-Acute and Chronic Low Back Pain

Interventions

Chiropractic care
Multidisciplinary, integrative care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R18HP07639

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Oct 2010Actual

Completion Date

Dec 2013Actual

First Submitted Date

Dec 3, 2007

First Submission Date that Met QC Criteria

Dec 3, 2007

First Posted Date

Dec 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2015

Last Update Posted Date

May 12, 2015Estimated

Name	Class
Health Resources and Services Administration (HRSA)	FED
Berman Center for Outcomes and Clinical Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

201Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other		Other: Chiropractic care
2	Other		Other: Multidisciplinary, integrative care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

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

Measure	Description	Time Frame
Frequency of Symptoms		12 and 52 weeks
Low Back Disability		12 and 52 weeks
Fear Avoidance

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Gert Bronfort, DC, PhD	Northwestern Health Sciences University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern Health Sciences University		Bloomington	Minnesota	55431	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35232482	Derived	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.
21034483	Derived	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.