Classification-Directed Treatment of Low Back Pain

Low Back Pain Clinical Trial

Official title:

Classification-Directed Treatment of Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802724
• Other study ID #: HD047709-04
• Secondary ID: HD047709-04
• Status: Completed
• Phase: Phase 1
• First received: December 4, 2008
• Last updated: October 18, 2012
• Start date: February 2007
• Est. completion date: November 2010

Study information

• Verified date: October 2012
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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 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.
• 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.

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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 J — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction with care (15-75 points)	Satisfaction with treatment	Completion of treatment phase	No
Primary	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	No
Secondary	Kinematic measures of select movements and postures	Impairment level measure	Baseline, completion of treatment phase	No
Secondary	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	No
Secondary	Medication use (yes, no)	Impairment level measure	Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	SF-36 Vitality subscale (0-100%)	Disability level measure	Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	SF-36 Role Functioning-Emotional subscale (0-100%)	Disability level measure	Baseline, completion of treatment phase, 6 months, 12 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No