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Home Program Education for Patients With Low Back Pain

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ClinicalTrials.gov Identifier: NCT02427438
Recruitment Status : Withdrawn (Not recruiting subjects currently)
First Posted : April 28, 2015
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:

The primary purpose of this study is to assess the effect size of the change in Oswestry Disability Questionnaire (ODQ) score over the 8 week follow-up period between the video based instruction or standard of care hand-out with pictures and written instructions for subjects meeting the clinical prediction rule for lumbar stabilization.

The second purpose will be to determine if there is a subset of physical examination and self-reported variables that are associated with having a successful result (ODQ improvement by at least 6 points) and if the subset of variables are affected by whether or not the subject was in the intervention (video) or control (handout) group.


Condition or disease Intervention/treatment Phase
Low Back Pain Lumbago Spinal Instability Other: Video Other: Handout Not Applicable

Detailed Description:

Approximately fifty percent of patients seeking help in outpatient orthopedic clinics and roughly thirty percent of people will experience some low back pain (LBP) at some time in their life.(1) LBP is the second leading cause of missed days of work per year and results in around ninety billion dollars per year in medical costs. (1) Physical therapy interventions for LBP could include manual therapy, exercise, traction, range of motion, modalities, postural education, or a combination of these interventions.(2-5) Medical treatment for LBP could include medications, imaging, laboratory studies, injections, surgery, or counseling through pain psychology.(6-7) Many research studies are inconclusive regarding effective treatment.

In 1995 a treatment based classification system for patients with acute low back pain was published.(8) Patients were categorized into one of four categories: manipulation, directional exercises (flexion, extension, lateral shift correction), immobilization, or traction. (8)This classification system led to further validation of the categories and clinical prediction rules (CPR) related to best treatment outcomes.(9-11) In 2005, Hicks built upon the initial classification system for immobilization when he published a preliminary CPR identifying which patients were most likely to benefit from lumbar stabilization.(10) Hicks identified the following predictors for patient response to stabilization exercises: individuals younger than age forty, straight leg raise greater than ninety-one degrees, and aberrant motions or a positive prone instability test.(10) Hicks reported a presence of three or more of these variables had a positive likelihood ratio of 4.0 for a 95% confidence interval.(10) However, no studies to date have confirmed such results nor validated this clinical prediction rule.

Home program prescription background Evidence for using video for home program prescription is limited. However, video based home programs have been successfully used for patients with Huntington's disease, traumatic brain injury (TBI), spinal cord injury, brachial plexus injuries, and general shoulder strengthening.(12-15) Medical studies demonstrate that patients comprehend information better when communicated via educational videos as opposed to educational pamphlets about various disorders.(16-18)

Problem Statement:

Currently, there is no literature evaluating the use of video home programs for patients with LBP or identifying who may benefit from this form of clinical education. Home program handouts frequently depict photographs or figures with incorrect form or instructions. Video based home programs demonstrating the stabilization techniques for patients may provide correct form and accurate instructions. With such programs, patient comprehension and technical reproduction of the exercises may improve. Video-based home programs could lead to fewer clinic visits and decreased cost per episode of care.

Given the numerous factors that contribute to limited clinic visits in LBP patients, more effective communication should be beneficial during treatment. We do not know if patient learning styles may influence compliance with varying modes of home exercise program prescriptions. Video based home exercise programs may also be a better fit for patients who are more auditory or visual learners as defined by the Visual, Auditory, Reading, Kinesthetic (VARK) learning inventory. (19) Auditory learners prefer information being transferred by listening. Visual learners prefer maps, charts, and perhaps videos over written charts or instructions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Home Program Education for Patients With Low Back Pain: Does it Matter? A Prospective Study
Study Start Date : February 2015
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Video Home Program Education
Subjects in this group will complete the same 8 weeks of home program exercises for lumbar instability. The home program exercises will be completed using a video with verbal instruction for guidance of proper technique and repetitions.
Other: Video
A video with moving demonstration and verbal instruction of the exercise to strengthen low back

Active Comparator: Handout Home Program Education
Subjects will complete the same 8 weeks of home program exercises for lumbar instability. The home program exercises will be completed using a handout with two dimensional pictures and written instructions for guidance of proper technique and repetitions.
Other: Handout
A handout with a two dimensional picture and written instruction of the exercise to strengthen low back




Primary Outcome Measures :
  1. Oswestry Disability Questionnaire (ODQ) [ Time Frame: 8 weeks ]
    The ODQ measures level of disability with patients presenting with low back pain. It is also reliable and has excellent construct validity.(10, 34-36) The ODQ will be assessed at baseline and after eight weeks of therapy to determine the overall success of stabilization based treatment on patient function.(10) The Oswestry has ten sections, one to assess pain and the remaining which assesses functional activities. Each section is scored from 0 to 5 which indicates the level of limitation with that given activity. Each score is then totaled and then doubled to give a percentage of disability. Higher scores on the Oswestry indicate greater levels of disability. A five to six point improvement on the Oswestry is considered the minimum clinically important difference with a fifty percent improvement being defined as "success" by Hicks.


Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: 8 weeks ]
    All subjects will complete a numeric pain rating using the traditional eleven point VAS scale. This will be assessed at every clinic visit. The VAS consists of a 100 mm line in which patients mark their pain on a scale from No Pain to Worst Pain Imaginable. This has been shown to be reliable and valid in prior research studies for low back pain. The VAS also is sensitive in detecting small amounts of change. 24 Prior research demonstrates that the repeatability of the VAS is good with correlation coefficients ranging from 0.97 to 0.99.(25) According to Jenson, the VAS also has greater levels of discrimination when using a 101 point scale.(26) Majority of research articles using the VAS define a statistically significant reduction as 50%.(26)


Other Outcome Measures:
  1. Fear and Avoidant Behaviors Questionnaire [ Time Frame: 8 weeks ]
    The Fear and Avoidant Behaviors Questionnaire (FABQ) will be used to screen for psychosocial contributions to a participants pain and function. The FABQ will be assessed at baseline and 8 weeks/discharge. Two subscales within this questionnaire assess physical activity and work. Responses are marked on a 7-point Likert scale ranging from completely disagree to completely agree. Higher scores indicate higher levels or fear-avoidance beliefs on both subscales. The FABQ is reliable and valid for use with LBP patients.27-29 Test retest reliability of the physical activity subscale has been shown to be acceptable at ICC=0.72 to 0.90. (30, 31) Fritz demonstrated that the FABQ work subscale can be used to identify which patients are at risk of not returning to work after four weeks of work-related injury. (32) A clinically important change level has not yet been determined for use of the FABQ. Woby however, demonstrated that changes in the FABQ have been correlated with changes in disability



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. presence of aberrant movement (Gower's sign, painful arc of motion, poor reversal of lumbopelvic rhythm)
  2. Positive prone instability test
  3. Straight leg raise greater than ninety-one degrees
  4. Age under 40

Exclusion Criteria:

  1. Anyone not meeting the 3/4 clinical prediction rules
  2. Those unable to access video based exercise instructions
  3. A prior spinal fusion, tumor, infection
  4. Two or more neurological symptoms such as upper motor neuron signs, myotomal weakness, dermatomal sensory changes, or abnormal reflexes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427438


Locations
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United States, Wisconsin
University of Wisconsin Spine Physical Therapy
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Tiffany Virag, MPT University of Wisconsin, Madison
Additional Information:
Publications of Results:

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02427438    
Other Study ID Numbers: 2012-0672
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Keywords provided by University of Wisconsin, Madison:
video
handout
home program
stabilization
strengthening
core
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations