Back to resultsUsing an Interactive Game to Reduce Fear and Increase Spine Motion in Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Game
Sponsored by
About this trial
This is an interventional basic science trial for Low Back Pain focused on measuring chronic low back pain
Eligibility Criteria
Inclusion Criteria:
Answer Yes to the following:
- Have you had low back pain constantly or on most days for the last 3 months?
- Has your back pain caused you to seek medical care?
- Low back pain is classified from category 1 (back pain that does not radiate) through category 3 (back pain that radiates beyond the knee, but without neurological signs) on the Classification System of the Quebec Task Force on Spinal Disorders.
- Report elevated levels of kinesiophobia.
- Report no health conditions that may restrict movement or preclude safe participation.
Exclusion Criteria:
Individuals must not:
- Have a personal history of the following neurological disorders: Alzheimer's, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's, Stroke
- Have a personal history of the following cardiorespiratory disorders: Congestive heart failure, Heart attack in past 24 months
- Have a personal history of the following musculoskeletal disorders: Rheumatoid Arthritis, pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis.
- Have a personal history of spine surgery or a hip arthroplasty
- Have active cancer or recent, unexplained weight loss
- Report being blind
- Report being pregnant
- Report current or pending litigation related to back pain
- Currently be taking narcotic medication
- Score in the clinically significant range for substance abuse (Drug Abuse Screening Test (DAST) > 6), alcohol abuse (Alcohol Use Disorders Identification Test (AUDIT-C) > 4), or depression (Center for Epidemiological Studies-Depression (CES-D) > 16).
Sites / Locations
- Ohio University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Game Condition
Control Condition
Arm Description
Participants in the GAME condition will complete laboratory sessions on five consecutive days. Session 1 (baseline) and Session 5 (post-test) will be used to assess lumbar spine motion and expectations of pain and harm during standardized reaching tasks. In sessions 2 through 4 they will play the virtual dodge ball game.
Participants in the CONTROL condition will complete baseline and post-test standardized reaching tasks, but will not play the game in the intervening three days.
Outcomes
Primary Outcome Measures
Lumbar spine flexion changes
This assessment tracks the magnitude of spine motion used to complete standardized reaching tasks in which participants reach to 3 targets (High, Middle, Low) located in the mid-sagittal plane. Participants will perform five reaching trials to each the target location and then return to an upright posture, with rest provided between each trial. Lumbar spine flexion will be defined as the change in joint angle (i.e., the difference between the joint angles at the beginning of the trial before the go signal and those extracted 100 ms after target contact). The average of the five reaches to each target location will serve as the dependent variable.
Expectation of pain changes
For each target height, prior to the first reaching trial participants will be asked to rate the level of "expected pain" using a visual analog scale. The scale will consist of a 10-cm horizontal line with no numbers, marks, or descriptive vocabulary along its length. The scale will be anchored with the descriptors "No pain" and "Worst pain imaginable", respectively, at each end of the line. The pain expectancy ratings for each target location will serve as the dependent variable.
Expectation of harm changes
For each target height, prior to the first reaching trial participants will be asked to rate the level of "expected harm" using a visual analog scale. The scale will consist of a 10-cm horizontal line with no numbers, marks, or descriptive vocabulary along its length. The scale will be anchored with "Not at all concerned" and "Extremely concerned" regarding potential harm to the back during task performance. The harm expectancy ratings for each target location will serve as the dependent variable.
Secondary Outcome Measures
Lumbar spine flexion change as a function of altered movement gain
Change in lumbar flexion measured during game play will be measured across the three gaming sessions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02301741
Brief Title
Using an Interactive Game to Reduce Fear and Increase Spine Motion in Low Back Pain
Official Title
Using an Interactive Game to Reduce Fear & Increase Spine Motion in Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A fundamental clinical problem in individuals with chronic low back pain is the significant alteration in movement patterns that restrict lumbar spine motion. This is particularly true for individuals with fear of re-injury with movement (i.e., kinesiophobia). The primary aims of the current study are to use a whole body video game environment to 1) determine the effects of game play on lumbar spine flexion and expectations of pain and harm and 2) determine the effects of altered movement gain on lumbar spine flexion.
Detailed Description
Using a 2 groups (Game, Control) between subjects design, the investigators will assess the influence of participation in a computer game of virtual dodge ball that requires whole-body reaching movements to manipulate an on-screen avatar. Further, the investigators will gradually reduce the gain of lumbar spine motion of the participant's on-screen avatar across the three game sessions such that participants will need to produce progressively larger excursions of the lumbar spine to manipulate their avatar's spinal motion. Specifically, in game session 1, the spine motion of the avatar is equal to that of the participant (gain=1); in session 2 spine motion of the avatar is 5% less than the participant (gain=0.95); in session 3 spine motion of the avatar is 10% less than the participant (gain=0.90). The investigators will recruit participants with chronic low back pain and kinesiophobia. Participants in the GAME condition will complete laboratory sessions on five consecutive days. Session 1 (baseline) and Session 5 (post-test) will be used to assess lumbar spine motion and expectations of pain and harm during standardized reaching tasks. In sessions 2 through 4 they will play the virtual dodge ball game. Participants in the CONTROL condition will complete baseline and post-test standardized reaching tasks, but will not play the game in the intervening three days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
chronic low back pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Game Condition
Arm Type
Experimental
Arm Description
Participants in the GAME condition will complete laboratory sessions on five consecutive days. Session 1 (baseline) and Session 5 (post-test) will be used to assess lumbar spine motion and expectations of pain and harm during standardized reaching tasks. In sessions 2 through 4 they will play the virtual dodge ball game.
Arm Title
Control Condition
Arm Type
No Intervention
Arm Description
Participants in the CONTROL condition will complete baseline and post-test standardized reaching tasks, but will not play the game in the intervening three days.
Intervention Type
Behavioral
Intervention Name(s)
Game
Intervention Description
We will assess the influence of participation in a computer game of virtual dodge ball that requires whole-body reaching movements to manipulate an on-screen avatar. We will gradually reduce the gain of lumbar spine motion of the participant's on-screen avatar across the three game sessions such that participants will need to produce progressively larger excursions of the lumbar spine to manipulate their avatar's spinal motion. Specifically, in game session 1, the spine motion of the avatar is equal to that of the participant (gain=1); in session 2 spine motion of the avatar is 5% less than the participant (gain=0.95); in session 3 spine motion of the avatar is 10% less than the participant (gain=0.90).
Primary Outcome Measure Information:
Title
Lumbar spine flexion changes
Description
This assessment tracks the magnitude of spine motion used to complete standardized reaching tasks in which participants reach to 3 targets (High, Middle, Low) located in the mid-sagittal plane. Participants will perform five reaching trials to each the target location and then return to an upright posture, with rest provided between each trial. Lumbar spine flexion will be defined as the change in joint angle (i.e., the difference between the joint angles at the beginning of the trial before the go signal and those extracted 100 ms after target contact). The average of the five reaches to each target location will serve as the dependent variable.
Time Frame
baseline (day 1) to post-test (day 5)
Title
Expectation of pain changes
Description
For each target height, prior to the first reaching trial participants will be asked to rate the level of "expected pain" using a visual analog scale. The scale will consist of a 10-cm horizontal line with no numbers, marks, or descriptive vocabulary along its length. The scale will be anchored with the descriptors "No pain" and "Worst pain imaginable", respectively, at each end of the line. The pain expectancy ratings for each target location will serve as the dependent variable.
Time Frame
baseline (day 1) to post-test (day 5)
Title
Expectation of harm changes
Description
For each target height, prior to the first reaching trial participants will be asked to rate the level of "expected harm" using a visual analog scale. The scale will consist of a 10-cm horizontal line with no numbers, marks, or descriptive vocabulary along its length. The scale will be anchored with "Not at all concerned" and "Extremely concerned" regarding potential harm to the back during task performance. The harm expectancy ratings for each target location will serve as the dependent variable.
Time Frame
baseline (day 1) to post-test (day 5)
Secondary Outcome Measure Information:
Title
Lumbar spine flexion change as a function of altered movement gain
Description
Change in lumbar flexion measured during game play will be measured across the three gaming sessions.
Time Frame
session day 2, 3 and 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Answer Yes to the following:
Have you had low back pain constantly or on most days for the last 3 months?
Has your back pain caused you to seek medical care?
Low back pain is classified from category 1 (back pain that does not radiate) through category 3 (back pain that radiates beyond the knee, but without neurological signs) on the Classification System of the Quebec Task Force on Spinal Disorders.
Report elevated levels of kinesiophobia.
Report no health conditions that may restrict movement or preclude safe participation.
Exclusion Criteria:
Individuals must not:
Have a personal history of the following neurological disorders: Alzheimer's, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's, Stroke
Have a personal history of the following cardiorespiratory disorders: Congestive heart failure, Heart attack in past 24 months
Have a personal history of the following musculoskeletal disorders: Rheumatoid Arthritis, pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis.
Have a personal history of spine surgery or a hip arthroplasty
Have active cancer or recent, unexplained weight loss
Report being blind
Report being pregnant
Report current or pending litigation related to back pain
Currently be taking narcotic medication
Score in the clinically significant range for substance abuse (Drug Abuse Screening Test (DAST) > 6), alcohol abuse (Alcohol Use Disorders Identification Test (AUDIT-C) > 4), or depression (Center for Epidemiological Studies-Depression (CES-D) > 16).
Facility Information:
Facility Name
Ohio University
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27616607
Citation
Thomas JS, France CR, Applegate ME, Leitkam ST, Walkowski S. Feasibility and Safety of a Virtual Reality Dodgeball Intervention for Chronic Low Back Pain: A Randomized Clinical Trial. J Pain. 2016 Dec;17(12):1302-1317. doi: 10.1016/j.jpain.2016.08.011. Epub 2016 Sep 9.
Results Reference
derived
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Using an Interactive Game to Reduce Fear and Increase Spine Motion in Low Back Pain
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