Clinical trial NCT02427438: Home Program Education for Patients With Low Back Pain
Official title: Home Program Education for Patients With Low Back Pain: Does it Matter? A Prospective Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Low Back Pain
Lumbago
Spinal Instability
Keywords: video
handout
home program
stabilization
strengthening
core
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Oswestry Disability Questionnaire (ODQ)
timeFrame: 8 weeks
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 8 weeks
Other outcomes:
measure: Fear and Avoidant Behaviors Questionnaire
timeFrame: 8 weeks
Locations:
city: Madison
country: United States
facility: University of Wisconsin Spine Physical Therapy
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Tiffany Virag, MPT
role: PRINCIPAL_INVESTIGATOR
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