Clinical trial NCT00802724: Classification-Directed Treatment of Low Back Pain
Official title: Classification-Directed Treatment of Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Low Back Pain
Keywords: low back pain
classification
spine
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
Collaborators: name: Washington University School of Medicine
First posted: 2008-12-05
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Modified Oswestry Disability Index for Low Back Pain (0-100%)
timeFrame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
Secondary outcomes:
measure: Kinematic measures of select movements and postures
timeFrame: Baseline, completion of treatment phase
measure: Numeric pain rating scale (0-10 points)
timeFrame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
measure: Medication use (yes, no)
timeFrame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
measure: Days of low back pain-related time off (number)
timeFrame: Baseline, 6 months after treatment phase, 12 months after treatment phase
measure: Baecke Habitual Activity Measure (3-15 points)
timeFrame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
measure: Fear Avoidance Beliefs Questionnaire Work subscale (0-42 points)
timeFrame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
measure: SF-36 Physical Functioning subscale (0-100%)
timeFrame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
measure: SF-36 Role Functioning-Physical subscale (0-100%)
timeFrame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
measure: SF-36 Bodily Pain subscale (0-100%)
timeFrame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
measure: SF-36 General Health subscale (0-100%)
timeFrame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
measure: SF-36 Vitality subscale (0-100%)
timeFrame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
measure: SF-36 Social Functioning Subscale (0-100%)
timeFrame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
measure: SF-36 Role Functioning subscale (0-100%)
timeFrame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
measure: Fear Avoidance Beliefs Activity subscale (0-24 points)
timeFrame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
measure: SF-36 Role Functioning-Emotional subscale (0-100%)
timeFrame: Baseline, completion of treatment phase, 6 months, 12 months
measure: SF-36 Mental Health subscale (0-100%)
timeFrame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase
measure: Adherence to exercise (0-100%)
timeFrame: Second treatment visit, completion of treatment phase, 6 months after treatment phase, 12 months after treatment phase
measure: Adherence to training in performance of functional activities (0-100%)
timeFrame: Second treatment visit, completion of treatment phase, 6 months post-treatment phase, 12 months post-treatment phase
Other outcomes:
measure: Satisfaction with care (15-75 points)
timeFrame: Completion of treatment phase
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Linda R Van Dillen, P.T., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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). 2009 Jan;24(1):7-12. doi: 10.1016/j.clinbiomech.2008.09.008. Epub 2008 Nov 5.
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.
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.
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.