Classification-Directed Treatment of Low Back Pain - Full Text View

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator:	Washington University School of Medicine
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00802724

Purpose

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. A secondary purpose is to identify the prognostic factors that contribute to outcomes in the 2 treatment groups. We hypothesize that treatment based on a person's direction-specific, impairment-based LBP classification 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.

Condition	Intervention	Phase
Low Back Pain	Behavioral: Classification-directed treatment Behavioral: Non-specific treatment	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Classification-Directed Treatment of Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Oswestry Disability Index for Low Back Pain - Functional limitation measure [ Time Frame: Baseline, 6 weeks, 6 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Kinematic measures of patients performing movement tests [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Classification treatment 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. 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 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. 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.
Active Comparator: 2 Non-specific treatment 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 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.

Arms

Assigned Interventions

Experimental: 1 Classification treatment

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. 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

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. 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.

Active Comparator: 2 Non-specific treatment

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 a 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,
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802724

Locations

United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63108

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Washington University School of Medicine

Investigators

Principal Investigator:

Linda R Van Dillen, P.T., Ph.D.

Washington University School of Medicine

More Information

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	Linda R. Van Dillen, Program in Physical Therapy, Washington University Medical School
ClinicalTrials.gov Identifier:	NCT00802724 History of Changes
Other Study ID Numbers:	HD047709-03, HD047709-03
Study First Received:	December 4, 2008
Last Updated:	May 12, 2010
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

low back pain
classification
spine

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012