Classification-Directed Treatment of Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Classification-Directed Treatment of Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: Classification-directed treatment
* Behavioral: Non-specific treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Classification-directed treatment<br>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<br>* 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.<br>|
| Active Comparator: 2 Non-specific treatment<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematic measures of select movements and postures | Impairment level measure | Baseline, completion of treatment phase | 
| Numeric pain rating scale (0-10 points) | Impairment level measure | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | 
| Medication use (yes, no) | Impairment level measure | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | 
| 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) | Baseline, 6 months after treatment phase, 12 months after treatment phase | 
| Baecke Habitual Activity Measure (3-15 points) | Impairment level measure | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | 
| Fear Avoidance Beliefs Questionnaire Work subscale (0-42 points) | Impairment level measure | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | 
| SF-36 Physical Functioning subscale (0-100%) | Disability level measure | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | 
| SF-36 Role Functioning-Physical subscale (0-100%) | Disability level measure | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | 
| SF-36 Bodily Pain subscale (0-100%) | Disability level measure | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | 
| SF-36 General Health subscale (0-100%) | Disability level measure | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | 
| SF-36 Vitality subscale (0-100%) | Disability level measure | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | 
| SF-36 Social Functioning Subscale (0-100%) | Disability level measure | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | 
| SF-36 Role Functioning subscale (0-100%) | Disability level measure | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | 
| Fear Avoidance Beliefs Activity subscale (0-24 points) | Impairment level measure | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | 
| SF-36 Role Functioning-Emotional subscale (0-100%) | Disability level measure | Baseline, completion of treatment phase, 6 months, 12 months | 
| SF-36 Mental Health subscale (0-100%) | Disability level measure | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | 
| Adherence to exercise (0-100%) | Measure of the percentage of times the person reports adhering to performing the exercise as prescribed | Second treatment visit, completion of treatment phase, 6 months after treatment phase, 12 months after treatment phase | 
| 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 | Second treatment visit, completion of treatment phase, 6 months post-treatment phase, 12 months post-treatment phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, classification, spine