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Completed

NCT Number: NCT00802724

Classification-Directed Treatment of Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University

St Louis, Missouri, 63108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Classification-directed treatment

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Modified Oswestry Disability Index for Low Back Pain (0-100%)

    Time frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

    Functional limitation measure

Secondary outcomes

  1. Kinematic measures of select movements and postures

    Time frame: Baseline, completion of treatment phase

    Impairment level measure

  2. Numeric pain rating scale (0-10 points)

    Time frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

    Impairment level measure

  3. Medication use (yes, no)

    Time frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

    Impairment level measure

  4. Days of low back pain-related time off (number)

    Time frame: 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)

  5. Baecke Habitual Activity Measure (3-15 points)

    Time frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

    Impairment level measure

  6. Fear Avoidance Beliefs Questionnaire Work subscale (0-42 points)

    Time frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

    Impairment level measure

  7. SF-36 Physical Functioning subscale (0-100%)

    Time frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

    Disability level measure

  8. SF-36 Role Functioning-Physical subscale (0-100%)

    Time frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

    Disability level measure

  9. SF-36 Bodily Pain subscale (0-100%)

    Time frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

    Disability level measure

  10. SF-36 General Health subscale (0-100%)

    Time frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

    Disability level measure

  11. SF-36 Vitality subscale (0-100%)

    Time frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

    Disability level measure

  12. SF-36 Social Functioning Subscale (0-100%)

    Time frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

    Disability level measure

  13. SF-36 Role Functioning subscale (0-100%)

    Time frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

    Disability level measure

  14. Fear Avoidance Beliefs Activity subscale (0-24 points)

    Time frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

    Impairment level measure

  15. SF-36 Role Functioning-Emotional subscale (0-100%)

    Time frame: Baseline, completion of treatment phase, 6 months, 12 months

    Disability level measure

  16. SF-36 Mental Health subscale (0-100%)

    Time frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase

    Disability level measure

  17. Adherence to exercise (0-100%)

    Time frame: 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

  18. Adherence to training in performance of functional activities (0-100%)

    Time frame: 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

Other outcomes

  1. Satisfaction with care (15-75 points)

    Time frame: Completion of treatment phase

    Satisfaction with treatment

Sponsors and collaborators

Lead sponsor

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

Nih

Collaborators

  • Washington University School of Medicine

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Dec 5, 2008
Registry last updated
Oct 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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