Low Back Pain
Conditions
Keywords
low back pain, classification, spine
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.
Interventions
BEHAVIORALClassification-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 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.
BEHAVIORALNon-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.
Sponsors
Washington University School of Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Oswestry Disability Index for Low Back Pain (0-100%) | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | Functional limitation measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days of low back pain-related time off (number) | Baseline, 6 months after treatment phase, 12 months after treatment phase | Impairment level measure; Question #5 from the Graded Chronic Pain Scale (Von Korff et al., Pain, 1990) |
| Baecke Habitual Activity Measure (3-15 points) | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | Impairment level measure |
| Kinematic measures of select movements and postures | Baseline, completion of treatment phase | Impairment level measure |
| Numeric pain rating scale (0-10 points) | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | Impairment level measure |
| Medication use (yes, no) | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | Impairment level measure |
| Fear Avoidance Beliefs Questionnaire Work subscale (0-42 points) | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | Impairment level measure |
| SF-36 Physical Functioning subscale (0-100%) | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | Disability level measure |
| SF-36 Role Functioning-Physical subscale (0-100%) | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | Disability level measure |
| SF-36 Bodily Pain subscale (0-100%) | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | Disability level measure |
| SF-36 Vitality subscale (0-100%) | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | Disability level measure |
| SF-36 Social Functioning Subscale (0-100%) | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | Disability level measure |
| SF-36 Role Functioning subscale (0-100%) | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | Disability level measure |
| Fear Avoidance Beliefs Activity subscale (0-24 points) | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | Impairment level measure |
| SF-36 Role Functioning-Emotional subscale (0-100%) | Baseline, completion of treatment phase, 6 months, 12 months | Disability level measure |
| SF-36 Mental Health subscale (0-100%) | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | Disability level measure |
| Adherence to exercise (0-100%) | Second treatment visit, completion of treatment phase, 6 months after treatment phase, 12 months after treatment phase | 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%) | Second treatment visit, completion of treatment phase, 6 months post-treatment phase, 12 months post-treatment phase | Measure of the percentage of times the person adhered to performing his/her functional activities as prescribed |
| SF-36 General Health subscale (0-100%) | Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase | Disability level measure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with care (15-75 points) | Completion of treatment phase | Satisfaction with treatment |
Countries
United States
Outcome results
None listed