Trial record 4 of 17 for:    learning disabilities | national institute of child health and development

Classification-Directed Treatment of Low Back Pain

This study has been completed.
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
Linda Van Dillen, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00802724
First received: December 4, 2008
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Behavioral: Classification-directed treatment
Behavioral: Non-specific treatment
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Classification-Directed Treatment of Low Back Pain

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Functional limitation measure


Secondary Outcome Measures:
  • Kinematic measures of select movements and postures [ Time Frame: Baseline, completion of treatment phase ] [ Designated as safety issue: No ]
    Impairment level measure

  • Numeric pain rating scale (0-10 points) [ Time Frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase ] [ Designated as safety issue: No ]
    Impairment level measure

  • Medication use (yes, no) [ Time Frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase ] [ Designated as safety issue: No ]
    Impairment level measure

  • Days of low back pain-related time off (number) [ Time Frame: Baseline, 6 months after treatment phase, 12 months after treatment phase ] [ Designated as safety issue: No ]
    Impairment level measure; Question #5 from the Graded Chronic Pain Scale (Von Korff et al., Pain, 1990)

  • Baecke Habitual Activity Measure (3-15 points) [ Time Frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase ] [ Designated as safety issue: No ]
    Impairment level measure

  • 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 ] [ Designated as safety issue: No ]
    Impairment level measure

  • SF-36 Physical Functioning subscale (0-100%) [ Time Frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase ] [ Designated as safety issue: No ]
    Disability level measure

  • 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 ] [ Designated as safety issue: No ]
    Disability level measure

  • SF-36 Bodily Pain subscale (0-100%) [ Time Frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase ] [ Designated as safety issue: No ]
    Disability level measure

  • SF-36 General Health subscale (0-100%) [ Time Frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase ] [ Designated as safety issue: No ]
    Disability level measure

  • SF-36 Vitality subscale (0-100%) [ Time Frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase ] [ Designated as safety issue: No ]
    Disability level measure

  • SF-36 Social Functioning Subscale (0-100%) [ Time Frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase ] [ Designated as safety issue: No ]
    Disability level measure

  • SF-36 Role Functioning subscale (0-100%) [ Time Frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase ] [ Designated as safety issue: No ]
    Disability level measure

  • 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 ] [ Designated as safety issue: No ]
    Impairment level measure

  • SF-36 Social Functioning subscale (0-100%) [ Time Frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase ] [ Designated as safety issue: No ]
    Disability level measure

  • SF-36 Role Functioning-Emotional subscale (0-100%) [ Time Frame: Baseline, completion of treatment phase, 6 months, 12 months ] [ Designated as safety issue: No ]
    Disability level measure

  • SF-36 Mental Health subscale (0-100%) [ Time Frame: Baseline, completion of treatment phase, 6 months after treatment phase,12 months after treatment phase ] [ Designated as safety issue: No ]
    Disability level measure

  • Adherence to exercise (0-100%) [ Time Frame: Second treatment visit, completion of treatment phase, 6 months after treatment phase, 12 months after treatment phase ] [ Designated as safety issue: No ]
    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%) [ Time Frame: Second treatment visit, completion of treatment phase, 6 months post-treatment phase, 12 months post-treatment phase ] [ Designated as safety issue: No ]
    Measure of the percentage of times the person adhered to performing his/her functional activities as prescribed


Other Outcome Measures:
  • Satisfaction with care (15-75 points) [ Time Frame: Completion of treatment phase ] [ Designated as safety issue: No ]
    Satisfaction with treatment


Enrollment: 101
Study Start Date: February 2007
Study Completion Date: November 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
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.
Active Comparator: 2 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.
Behavioral: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802724

Locations
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Linda R Van Dillen, P.T., Ph.D. Washington University Early Recognition Center
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Linda Van Dillen, Associate Professor, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00802724     History of Changes
Other Study ID Numbers: HD047709-04, HD047709-04
Study First Received: December 4, 2008
Last Updated: October 18, 2012
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
low back pain
classification
spine

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014