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Home Program Education for Patients With Low Back Pain

Primary Purpose

Low Back Pain, Lumbago, Spinal Instability

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video
Handout
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring video, handout, home program, stabilization, strengthening, core

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Wisconsin Spine Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Video Home Program Education

Handout Home Program Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Oswestry Disability Questionnaire (ODQ)
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

Visual Analog Scale (VAS)
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)

Full Information

First Posted
April 22, 2015
Last Updated
October 24, 2017
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT02427438
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Not recruiting subjects currently
Study Start Date
February 2015 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Lumbago, Spinal Instability
Keywords
video, handout, home program, stabilization, strengthening, core

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video Home Program Education
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Handout Home Program Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Video
Intervention Description
A video with moving demonstration and verbal instruction of the exercise to strengthen low back
Intervention Type
Other
Intervention Name(s)
Handout
Intervention Description
A handout with a two dimensional picture and written instruction of the exercise to strengthen low back
Primary Outcome Measure Information:
Title
Oswestry Disability Questionnaire (ODQ)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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)
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Fear and Avoidant Behaviors Questionnaire
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: presence of aberrant movement (Gower's sign, painful arc of motion, poor reversal of lumbopelvic rhythm) Positive prone instability test Straight leg raise greater than ninety-one degrees Age under 40 Exclusion Criteria: Anyone not meeting the 3/4 clinical prediction rules Those unable to access video based exercise instructions A prior spinal fusion, tumor, infection Two or more neurological symptoms such as upper motor neuron signs, myotomal weakness, dermatomal sensory changes, or abnormal reflexes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Virag, MPT
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Spine Physical Therapy
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States

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Links:
URL
http://painfoundation.org
Description
American Pain Foundation

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Home Program Education for Patients With Low Back Pain

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