NCT00802724

Brief Summary

The primary purpose of this proposal is to conduct a prospective, randomized, controlled clinical trial to examine whether or not treatment based on a person's direction-specific, impairment-based LBP classification is more effective than Non-specific treatment in improving short- (6 weeks) and long-term (6 and 12 months) outcomes in people with chronic LBP. We hypothesize that treatment based on a person's direction-specific, impairment-based LBP classification (Classification-specific) will result in better outcomes than Non-specific treatment. Our approach to classification-directed treatment is based on the proposal that a person's LBP is the result of adopting direction-specific strategies of movement and alignment of the spine which then are used repeatedly during the person's everyday activities. The exposure of spine tissue to repeated loading in the same direction across a day is proposed to accelerate the accumulation of stress, microtrauma, and eventually LBP. We also hypothesize that until the factors contributing to the use of the direction-specific strategies of the spine are modified, the LBP problem will persist or recur. Identification of homogeneous subgroups of people with LBP will enhance 1) the power of clinical trials, 2) prognosis, and 3) the ability to identify mechanisms contributing to different LBP problems.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P75+ for phase_1 low-back-pain

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_1 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

October 22, 2012

Status Verified

October 1, 2012

Enrollment Period

2.5 years

First QC Date

December 4, 2008

Last Update Submit

October 18, 2012

Conditions

Low Back Pain

Keywords

low back painclassificationspine

Outcome Measures

Primary Outcomes (1)

  • Modified Oswestry Disability Index for Low Back Pain (0-100%)

    Functional limitation measure

    Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

Secondary Outcomes (18)

  • Kinematic measures of select movements and postures

    Baseline, completion of treatment phase

  • Numeric pain rating scale (0-10 points)

    Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

  • Medication use (yes, no)

    Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

  • Days of low back pain-related time off (number)

    Baseline, 6 months after treatment phase, 12 months after treatment phase

  • Baecke Habitual Activity Measure (3-15 points)

    Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

  • +13 more secondary outcomes

Other Outcomes (1)

  • Satisfaction with care (15-75 points)

    Completion of treatment phase

Study Arms (2)

1 Classification-directed treatment

EXPERIMENTAL

People in the Classification-directed treatment will be treated based on their direction-specific LBP classification. Treatment will consist of 3 primary components. The first component of treatment will be analysis and instruction in modification of the person's direction-specific alignment and movement strategies during symptomatic functional activities and activities in which the person uses similar strategies to those displayed with symptomatic functional activities. The second component is education about the principles of tissue injury and healing and the need to keep active. The third component is exercise prescription that consists of practice in performance of modified versions of the direction-specific impairment tests from the exam, with an emphasis on impairments that can be modified to eliminate symptoms.

Behavioral: Classification-directed treatment

2 Non-specific treatment

ACTIVE COMPARATOR

People in the Non-specific treatment will be provided treatment that incorporates treatment commonly cited in the literature for people with chronic LBP. The first component of treatment will consist of training in functional activities based on biomechanical principles. The second component will include general education about low back pain. The third component is exercise prescription that is directed at improving the strength and flexibility of the trunk and limbs.

Behavioral: Non-specific treatment

Interventions

Classification-directed treatmentBEHAVIORAL

People in the Classification-directed treatment will be treated based on their direction-specific LBP classification. Treatment will consist of 3 primary components. The first component of treatment will be analysis and instruction in modification of the person's direction-specific alignment and movement strategies during symptomatic functional activities and activities in which the person uses similar strategies to those displayed with symptomatic functional activities. The second component is education about the principles of tissue injury and healing and the need to keep active. The third component is exercise prescription that consists of practice in performance of modified versions of the direction-specific impairment tests from the exam, with an emphasis on impairments that can be modified to eliminate symptoms.

1 Classification-directed treatment
Non-specific treatmentBEHAVIORAL

People in the Non-specific treatment will be provided treatment that incorporates treatment commonly cited in the literature for people with chronic LBP. The first component of treatment will consist of training in functional activities based on biomechanical principles. The second component will include general education about low back pain. The third component is exercise prescription that is directed at improving the strength and flexibility of the trunk and limbs.

2 Non-specific treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • People who report a history of chronic LBP for a minimum of 12 months,currently are experiencing LBP symptoms but not in an acute recurrence,
  • Between 18 and 60 years of age,
  • Able to stand and walk without assistance,
  • Able to understand and read English,
  • Able to understand and sign a consent form

You may not qualify if:

  • Any structural spinal deformity including scoliosis, kyphosis, or stenosis,
  • A spinal fracture or dislocation,
  • Osteoporosis,
  • Ankylosing spondylitis,
  • Rheumatoid arthritis,
  • Disc herniation,
  • Serious spinal complications such as tumor or infection,
  • Previous spinal surgery,
  • Frank neurological loss, i.e., weakness and sensory loss,
  • Pain or paresthesia below the knee,
  • Etiology of LBP other than the lumbar spine, e.g., hip joint,
  • History of neurologic disease which required hospitalization,
  • Active treatment for cancer,
  • History of unresolved cancer,
  • Pregnancy,
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63108, United States

Location

Related Publications (11)

  • Holtzman G, Harris-Hayes M, Hoffman SL, Zou D, Edgeworth RA, Van Dillen LR. Clinical examination procedures to determine the effect of axial decompression on low back pain symptoms in people with chronic low back pain. J Orthop Sports Phys Ther. 2012 Feb;42(2):105-13. doi: 10.2519/jospt.2012.3724. Epub 2011 Oct 25.

    PMID: 22027267BACKGROUND

  • Hoffman SL, Harris-Hayes M, Van Dillen LR. Differences in activity limitation between 2 low back pain subgroups based on the movement system impairment model. PM R. 2010 Dec;2(12):1113-8. doi: 10.1016/j.pmrj.2010.09.003.

    PMID: 21145523BACKGROUND

  • Harris-Hayes M, Holtzman GW, Earley JA, Van Dillen LR. Development and preliminary reliability testing of an assessment of patient independence in performing a treatment program: standardized scenarios. J Rehabil Med. 2010 Mar;42(3):221-7. doi: 10.2340/16501977-0505.

    PMID: 20411216BACKGROUND

  • Hoffman SL, Johnson MB, Zou D, Van Dillen LR. Differences in end-range lumbar flexion during slumped sitting and forward bending between low back pain subgroups and genders. Man Ther. 2012 Apr;17(2):157-63. doi: 10.1016/j.math.2011.12.007. Epub 2012 Jan 17.

    PMID: 22261650BACKGROUND

  • Ravenna MM, Hoffman SL, Van Dillen LR. Low interrater reliability of examiners performing the prone instability test: a clinical test for lumbar shear instability. Arch Phys Med Rehabil. 2011 Jun;92(6):913-9. doi: 10.1016/j.apmr.2010.12.042.

    PMID: 21621668BACKGROUND

  • Scholtes SA, Norton BJ, Lang CE, Van Dillen LR. The effect of within-session instruction on lumbopelvic motion during a lower limb movement in people with and people without low back pain. Man Ther. 2010 Oct;15(5):496-501. doi: 10.1016/j.math.2010.05.003. Epub 2010 Jun 2.

    PMID: 20627798BACKGROUND

  • Harris-Hayes M, Van Dillen LR. The inter-tester reliability of physical therapists classifying low back pain problems based on the movement system impairment classification system. PM R. 2009 Feb;1(2):117-26. doi: 10.1016/j.pmrj.2008.08.001. Epub 2008 Dec 27.

    PMID: 19627885BACKGROUND

  • Scholtes SA, Gombatto SP, Van Dillen LR. Differences in lumbopelvic motion between people with and people without low back pain during two lower limb movement tests. Clin Biomech (Bristol). 2009 Jan;24(1):7-12. doi: 10.1016/j.clinbiomech.2008.09.008. Epub 2008 Nov 5.

    PMID: 18990474BACKGROUND

  • Henry SM, Van Dillen LR, Trombley AR, Dee JM, Bunn JY. Reliability of novice raters in using the movement system impairment approach to classify people with low back pain. Man Ther. 2013 Feb;18(1):35-40. doi: 10.1016/j.math.2012.06.008. Epub 2012 Jul 15.

    PMID: 22796388BACKGROUND

  • Hoffman SL, Johnson MB, Zou D, Harris-Hayes M, Van Dillen LR. Effect of classification-specific treatment on lumbopelvic motion during hip rotation in people with low back pain. Man Ther. 2011 Aug;16(4):344-50. doi: 10.1016/j.math.2010.12.007. Epub 2011 Jan 20.

    PMID: 21256073RESULT

  • Hoffman SL, Johnson MB, Zou D, Van Dillen LR. Sex differences in lumbopelvic movement patterns during hip medial rotation in people with chronic low back pain. Arch Phys Med Rehabil. 2011 Jul;92(7):1053-9. doi: 10.1016/j.apmr.2011.02.015.

    PMID: 21704784DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Linda R Van Dillen, P.T., Ph.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 4, 2008

First Posted

December 5, 2008

Study Start

February 1, 2007

Primary Completion

August 1, 2009

Study Completion

November 1, 2010

Last Updated

October 22, 2012

Record last verified: 2012-10

Locations

US(1)