Trial record 9 of 1737 for:    Back Pain

Spinal Control During Functional Activities to Improve Low Back Pain Outcomes (LBP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Washington University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Linda Van Dillen, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02027623
First received: January 2, 2014
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

Exercise is one of the primary interventions used with people with chronic, mechanical low back pain. It is unknown, however, which exercise is best for which person, which exercises a person will adhere to and for how long, and the effect of adhering to a specific type of exercise on how the person functions, particularly in the long run. The purpose of this study is to examine if the short- and long-term effects are different between 1) commonly prescribed strength and flexibility exercises for the trunk and limbs, and 2) individualized practice in daily functional activities that are difficult or painful to perform. Adherence to the different interventions, the relationship between adherence and outcomes,as well as the effect of a booster intervention also will be examined.


Condition Intervention Phase
Mechanical Low Back Pain
Chronic Low Back Pain
Behavioral: Motor skill training
Behavioral: Strength and flexibility exercise
Phase 1
Phase 2

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: Spinal Control During Functional Activities to Improve Low Back Pain Outcomes

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Change in Modified Oswestry Disability Index (0-100%) from baseline to completion of initial 6 week intervention phase [ Time Frame: Baseline, completion of initial 6 week intervention phase ] [ Designated as safety issue: No ]
  • Change in Modified Oswestry Disability Index (0-100%) from completion of initial 6 week intervention phase to 6 months after initial intervention phase [ Time Frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in Modified Oswestry Disability Index (0-100%) from 6 months after initial intervention phase to 12 months after initial intervention phase [ Time Frame: 6 months after initial intervention phase, 12 months after initial intervention phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Numeric Rating Scale of Symptoms (0-10) from baseline to completion of initial 6 week intervention phase [ Time Frame: Baseline, completion of initial 6 week intervention phase ] [ Designated as safety issue: No ]
  • Change in Numeric Rating Scale of Symptoms (0-10) from completion of initial 6 week intervention phase to 6 months after initial intervention phase [ Time Frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in Numeric Rating Scale of Symptoms (0-10) from 6 months after initial intervention phase to 12 months after initial intervention phase [ Time Frame: 6 months after initial intervention phase, 12 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in number of low back pain flare-ups (#) in past 6 months, from baseline to 6 months after initial intervention phase [ Time Frame: Baseline, 6 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in number of low back pain flare-ups (#) in past 6 months, from 6 months after the initial intervention phase to 12 months afer initial intervention phase [ Time Frame: 6 months after initial intervention phase, 12 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in use of low back pain-related medications (yes regularly, yes as needed, no) from baseline to completion of initial 6 week intervention phase [ Time Frame: Baseline, completion of initial 6 week intervention phase ] [ Designated as safety issue: No ]
  • Change in use (yes regularly, yes as needed, no) of low back pain medications from completion of initial 6 week intervention phase to 6 months after initial intervention phase [ Time Frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in use (yes regularly, yes as needed, no) of low back pain medications from 6 months after completion of initial intervention phase to 12 months after completion of initial intervention phase [ Time Frame: 6 months after initial intervention phase, 12 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in absenteeism due to low back pain (number (#) of days) from baseline to completion of initial 6 week intervention phase [ Time Frame: Baseline, completion of initial 6 week intervention phase ] [ Designated as safety issue: No ]
  • Change in absenteeism due to low back pain (number (#) of days) from completion of initial 6 week intervention phase to 6 months after initial intervention phase [ Time Frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in absenteeism due to low back pain (number (#) of days) from 6 months after initial intervention phase to 12 months after initial intervention phase [ Time Frame: 6 months after initial intervention phase, 12 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in presenteeism (work impairment score: 0-100%) from baseline to completion of initial 6 week intervention phase [ Time Frame: Baseline, completion of initial 6 week intervention phase ] [ Designated as safety issue: No ]
  • Change in presenteeism (work impairment score: 0-100%) from completion of initial 6 week intervention phase to 6 months after initial intervention phase [ Time Frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in presenteeism (work impairment score: 0-100%) from 6 months after initial intervention phase to 12 months after initial intervention phase [ Time Frame: 6 months after initial intervention phase, 12 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in Physical component summary score of Short Form (SF) -36 (0-100%) from baseline to completion of initial 6 week intervention phase [ Time Frame: Baseline, completion of initial 6 week intervention phase ] [ Designated as safety issue: No ]
  • Change in Physical component summary score of SF-36 (0-100%) from completion of initial 6 week intervention phase to 6 months after initial intervention phase [ Time Frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in Physical component summary score of SF-36 (0-100%) from 6 months after initial intervention phase to 12 months after initial intervention phase [ Time Frame: 6 months after initial intervention phase, 12 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in Mental component summary score of SF-36 (0-100%) from baseline to completion of initial 6 week intervention phase [ Time Frame: Baseline, completion of initial 6 week intervention phase ] [ Designated as safety issue: No ]
  • Change in Mental component summary score of SF-36 (0-100%) from completion of initial 6 week intervention phase to 6 months after initial intervention phase [ Time Frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in Mental component summary score of SF-36 (0-100%) from 6 months after initial intervention phase to 12 months after initial intervention phase [ Time Frame: 6 months after initial intervention phase, 12 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in use of other low back pain-related treatments (healthcare or equipment (#)) from baseline to completion of initial 6 week intervention phase [ Time Frame: Baseline, completion of initial 6 week intervention phase ] [ Designated as safety issue: No ]
  • Change in use of other low back pain-related treatments (healthcare or equipment (#)) from completion of initial 6 week intervention phase to 6 months after initial intervention phase [ Time Frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in use of other low back pain-related treatments (healthcare or equipment (#)) from 6 months after initial intervention phase to 12 months after initial intervention phase [ Time Frame: 6 months after initial intervention phase, 12 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Satisfaction with care (15-75 points) [ Time Frame: Completion of initial 6 week intervention phase ] [ Designated as safety issue: No ]
  • Change in kinematics during functional activities (degrees) from baseline to completion of initial 6 week intervention phase [ Time Frame: Baseline, completion of initial 6 week intervention phase ] [ Designated as safety issue: No ]
  • Change in kinematics during functional activities (degrees) from completion of initial 6 week intervention phase to 6 months after intervention phase [ Time Frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in adherence to prescribed intervention (0-100%) from intervention visit 2 to completion of initial 6 week intervention phase [ Time Frame: Intervention visit 2, completion of initial 6 week intervention phase ] [ Designated as safety issue: No ]
  • Change in adherence to prescribed intervention (0-100%) from completion of initial 6 week intervention phase to 6 months after completion of initial intervention phase [ Time Frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in adherence to prescribed intervention (0-100%) from 6 months after completion of initial intervention phase to 12 months after initial intervention phase [ Time Frame: 6 months after initial intervention phase, 12 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in work subscale score of Fear Avoidance Beliefs Questionnaire (0-42 points) from baseline to completion of initial 6 week intervention phase [ Time Frame: Baseline, completion of initial 6 week intervention phase ] [ Designated as safety issue: No ]
  • Change in work subscale score of Fear Avoidance Beliefs Questionnaire (0-42 points) from completion of initial 6 week intervention phase to 6 months after initial intervention phase [ Time Frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in work subscale score of Fear Avoidance Beliefs Questionnaire (0-42 points) from 6 months after initial intervention phase to 12 months after initial intervention phase [ Time Frame: 6 months after initial intervention phase, 12 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in physical activity subscale score of Fear Avoidance Beliefs Questionnaire (0-24 points) from baseline to completion of initial 6 week intervention phase [ Time Frame: Baseline, completion of initial 6 week intervention phase ] [ Designated as safety issue: No ]
  • Change in physical activity subscale score of Fear Avoidance Beliefs Questionnaire (0-24 points) from completion of initial 6 week intervention phase to 6 months after initial intervention phase [ Time Frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in physical activity subscale score of Fear Avoidance Beliefs Questionnaire (0-24 points) from 6 months after initial intervention phase to 12 months after initial intervention phase [ Time Frame: 6 months after initial intervention phase, 12 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Treatment Acceptability, Preference, and Convenience measure, effectiveness subscale (0-4 points) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Treatment Acceptability, Preference, and Convenience measure, acceptable/logical subscale (0-4 points) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Treatment Acceptability, Preference, and Convenience measure, suitable/appropriate subscale (0-4 points) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Treatment Acceptability, Preference, and Convenience measure, convenience subscale (0-4 points) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Change in direct and indirect health care costs (estimated costs) from baseline to completion of initial 6 week intervention phase [ Time Frame: Baseline, completion of initial 6 week intervention phase ] [ Designated as safety issue: No ]
  • Change in direct and indirect healthcare costs (estimated costs) from completion of initial 6 week intervention phase to 6 months after initial intervention phase [ Time Frame: Completion of initial 6 week intervention phase, 6 months after initial intervention phase ] [ Designated as safety issue: No ]
  • Change in direct and indirect healthcare costs (estimated costs) from 6 months after initial intervention phase to 12 months after initial intervention phase [ Time Frame: 6 months after initial intervention phase, 12 months after initial intervention phase ] [ Designated as safety issue: No ]

Estimated Enrollment: 154
Study Start Date: December 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motor skill training
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Behavioral: Motor skill training
The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment will be provided as needed.
Active Comparator: Strength and flexibility exercise
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Behavioral: Strength and flexibility exercise
Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.

Detailed Description:

For many people, mechanical low back pain (LBP) is a long-term, function-limiting condition rather than a short-term, self-limiting condition. Exercise is one of the primary non-surgical approaches used worldwide for managing LBP. Specifically in people with chronic LBP, exercise has been found to be as efficacious, if not more efficacious than 1) no treatment, 2) usual care, and 3) many other treatments, such as massage or laser therapy. Despite the growing body of evidence for the beneficial effects of exercise, however, there is limited evidence about 1) which exercise is best for which person, 2) how long the effects of different exercises last, 3) which types of exercise people will adhere to, and for how long, and 4) the mechanisms underlying the effects of different types of exercise.

This study aims to address these limitations by directly comparing the effects of 1) exercise to increase strength of the trunk and increase flexibility of the trunk and extremities, and 2) individualized, motor skill training directed at performance of daily functional activities that are painful or limited due to the person's LBP. This study also will examine 1) the effects of a booster phase of intervention, 2) the relationship between adherence to intervention and function, and 3) the relationship between performance of functional activities and function-related outcomes. People with chronic LBP will be randomized to 1) an intervention of strength and flexibility exercise or motor skill training, and 2) a booster or no-booster intervention. Intervention will be provided in 2 phases: 1) initial phase: 6 - 1 hour sessions, once/week for 6 weeks, and 2) booster phase: # of sessions needed to regain independence in home program, beginning 6 months after the initial phase. The investigators will collect 1) measurements of pain, function, disability, and economic outcomes, 2) reports of adherence, and 3) laboratory-based measures of performance of functional activities. People will be followed for 12 months after the initial intervention phase. Three sets of hypotheses are proposed. First, the investigators hypothesize that both interventions will result in improvements in pain, function, disability, and economic outcomes, but that the motor skill training will result in more long lasting improvements than the strength and flexibility exercise. Second, the investigators hypothesize that the effect of a booster phase of intervention will 1) result in longer lasting improvement in function and better adherence than a no-booster intervention, and 2) be greater for motor skill training than for strength and flexibility exercise. Finally, the investigators hypothesize that 1) adherence to motor skill training will be more strongly related to function than will adherence to strength and flexibility exercise, and 2) performance of functional activities by people receiving motor skill training will be more strongly related to function than performance of functional activities by people receiving strength and flexibility exercise.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic low back pain for a minimum of 12 months
  • currently experiencing low back pain symptoms but not in a recurrence or an acute flare-up
  • Modified Oswestry Disability Index score of ≥ 20%
  • 3 or more functional activities limited due to low back pain
  • able to stand and walk without assistance
  • able to understand and sign a consent form

Exclusion Criteria:

  • any structural spinal deformity including scoliosis, kyphosis, or stenosis
  • spinal fracture or dislocation
  • low back pain due to trauma
  • osteoporosis
  • ankylosing spondylitis
  • rheumatoid arthritis
  • disc herniation
  • spondylolisthesis
  • 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 low back pain 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
  • worker's compensation, disability, or litigation case
  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: NCT02027623

Contacts
Contact: Jennifer Jarvis, M.S. 3142861190 lvdlab@wusm.wustl.edu
Contact: Sara Bohall, M.S. 3142861190 lvdlab@wusm.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63018-2212
Contact: Linda R Van Dillen, P.T., Ph.D.         
Principal Investigator: Linda R Van Dillen, P.T., Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Linda R Van Dillen, P.T., Ph.D. Program in Physical Therapy, Washington University Medical School
  More Information

No publications provided

Responsible Party: Linda Van Dillen, Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02027623     History of Changes
Other Study ID Numbers: 201205051, 2R01HD047709
Study First Received: January 2, 2014
Last Updated: February 11, 2014
Health Authority: United States: Federal Government

Keywords provided by Washington University School of Medicine:
Mechanical low back pain
Non-specific low back pain
Exercise
Motor skill training

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 29, 2014