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Classification-Directed Treatment of Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Classification-directed treatment
Non-specific treatment
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, classification, spine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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,
  • Magnified symptom behavior,
  • Worker's compensation or disability case,
  • In litigation for the LBP problem,
  • Referral from a specialized pain clinic source,
  • Spondylolisthesis

Sites / Locations

  • Washington University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 Classification-directed treatment

2 Non-specific treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Modified Oswestry Disability Index for Low Back Pain (0-100%)
Functional limitation measure

Secondary Outcome Measures

Kinematic measures of select movements and postures
Impairment level measure
Numeric pain rating scale (0-10 points)
Impairment level measure
Medication use (yes, no)
Impairment level measure
Days of low back pain-related time off (number)
Impairment level measure; Question #5 from the Graded Chronic Pain Scale (Von Korff et al., Pain, 1990)
Baecke Habitual Activity Measure (3-15 points)
Impairment level measure
Fear Avoidance Beliefs Questionnaire Work subscale (0-42 points)
Impairment level measure
SF-36 Physical Functioning subscale (0-100%)
Disability level measure
SF-36 Role Functioning-Physical subscale (0-100%)
Disability level measure
SF-36 Bodily Pain subscale (0-100%)
Disability level measure
SF-36 General Health subscale (0-100%)
Disability level measure
SF-36 Vitality subscale (0-100%)
Disability level measure
SF-36 Social Functioning Subscale (0-100%)
Disability level measure
SF-36 Role Functioning subscale (0-100%)
Disability level measure
Fear Avoidance Beliefs Activity subscale (0-24 points)
Impairment level measure
SF-36 Role Functioning-Emotional subscale (0-100%)
Disability level measure
SF-36 Mental Health subscale (0-100%)
Disability level measure
Adherence to exercise (0-100%)
Measure of the percentage of times the person reports adhering to performing the exercise as prescribed
Adherence to training in performance of functional activities (0-100%)
Measure of the percentage of times the person adhered to performing his/her functional activities as prescribed

Full Information

First Posted
December 4, 2008
Last Updated
October 18, 2012
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00802724
Brief Title
Classification-Directed Treatment of Low Back Pain
Official Title
Classification-Directed Treatment of Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, classification, spine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Classification-directed treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
2 Non-specific treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Classification-directed treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Non-specific treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Oswestry Disability Index for Low Back Pain (0-100%)
Description
Functional limitation measure
Time Frame
Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Secondary Outcome Measure Information:
Title
Kinematic measures of select movements and postures
Description
Impairment level measure
Time Frame
Baseline, completion of treatment phase
Title
Numeric pain rating scale (0-10 points)
Description
Impairment level measure
Time Frame
Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Title
Medication use (yes, no)
Description
Impairment level measure
Time Frame
Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Title
Days of low back pain-related time off (number)
Description
Impairment level measure; Question #5 from the Graded Chronic Pain Scale (Von Korff et al., Pain, 1990)
Time Frame
Baseline, 6 months after treatment phase, 12 months after treatment phase
Title
Baecke Habitual Activity Measure (3-15 points)
Description
Impairment level measure
Time Frame
Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Title
Fear Avoidance Beliefs Questionnaire Work subscale (0-42 points)
Description
Impairment level measure
Time Frame
Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Title
SF-36 Physical Functioning subscale (0-100%)
Description
Disability level measure
Time Frame
Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Title
SF-36 Role Functioning-Physical subscale (0-100%)
Description
Disability level measure
Time Frame
Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Title
SF-36 Bodily Pain subscale (0-100%)
Description
Disability level measure
Time Frame
Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Title
SF-36 General Health subscale (0-100%)
Description
Disability level measure
Time Frame
Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Title
SF-36 Vitality subscale (0-100%)
Description
Disability level measure
Time Frame
Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Title
SF-36 Social Functioning Subscale (0-100%)
Description
Disability level measure
Time Frame
Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Title
SF-36 Role Functioning subscale (0-100%)
Description
Disability level measure
Time Frame
Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Title
Fear Avoidance Beliefs Activity subscale (0-24 points)
Description
Impairment level measure
Time Frame
Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Title
SF-36 Role Functioning-Emotional subscale (0-100%)
Description
Disability level measure
Time Frame
Baseline, completion of treatment phase, 6 months, 12 months
Title
SF-36 Mental Health subscale (0-100%)
Description
Disability level measure
Time Frame
Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Title
Adherence to exercise (0-100%)
Description
Measure of the percentage of times the person reports adhering to performing the exercise as prescribed
Time Frame
Second treatment visit, completion of treatment phase, 6 months after treatment phase, 12 months after treatment phase
Title
Adherence to training in performance of functional activities (0-100%)
Description
Measure of the percentage of times the person adhered to performing his/her functional activities as prescribed
Time Frame
Second treatment visit, completion of treatment phase, 6 months post-treatment phase, 12 months post-treatment phase
Other Pre-specified Outcome Measures:
Title
Satisfaction with care (15-75 points)
Description
Satisfaction with treatment
Time Frame
Completion of treatment phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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, Magnified symptom behavior, Worker's compensation or disability case, In litigation for the LBP problem, Referral from a specialized pain clinic source, Spondylolisthesis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda R Van Dillen, P.T., Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22027267
Citation
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.
Results Reference
background
PubMed Identifier
21145523
Citation
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.
Results Reference
background
PubMed Identifier
20411216
Citation
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.
Results Reference
background
PubMed Identifier
22261650
Citation
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.
Results Reference
background
PubMed Identifier
21621668
Citation
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.
Results Reference
background
PubMed Identifier
20627798
Citation
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.
Results Reference
background
PubMed Identifier
19627885
Citation
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.
Results Reference
background
PubMed Identifier
18990474
Citation
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, Avon). 2009 Jan;24(1):7-12. doi: 10.1016/j.clinbiomech.2008.09.008. Epub 2008 Nov 5.
Results Reference
background
PubMed Identifier
22796388
Citation
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.
Results Reference
background
PubMed Identifier
21256073
Citation
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.
Results Reference
result
PubMed Identifier
21704784
Citation
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.
Results Reference
derived

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Classification-Directed Treatment of Low Back Pain

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