Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Using an Interactive Game to Reduce Fear and Increase Spine Motion in Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02301741
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):
Ohio University

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Behavioral: Game Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Using an Interactive Game to Reduce Fear & Increase Spine Motion in Low Back Pain
Study Start Date : January 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Game Condition
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.
Behavioral: Game
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).

No Intervention: Control Condition
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.



Primary Outcome Measures :
  1. Lumbar spine flexion changes [ Time Frame: baseline (day 1) to post-test (day 5) ]
    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.

  2. Expectation of pain changes [ Time Frame: baseline (day 1) to post-test (day 5) ]
    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.

  3. Expectation of harm changes [ Time Frame: baseline (day 1) to post-test (day 5) ]
    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 :
  1. Lumbar spine flexion change as a function of altered movement gain [ Time Frame: session day 2, 3 and 4 ]
    Change in lumbar flexion measured during game play will be measured across the three gaming sessions.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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?
  2. 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.
  3. Report elevated levels of kinesiophobia.
  4. Report no health conditions that may restrict movement or preclude safe participation.

Exclusion Criteria:

Individuals must not:

  1. Have a personal history of the following neurological disorders: Alzheimer's, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's, Stroke
  2. Have a personal history of the following cardiorespiratory disorders: Congestive heart failure, Heart attack in past 24 months
  3. Have a personal history of the following musculoskeletal disorders: Rheumatoid Arthritis, pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis.
  4. Have a personal history of spine surgery or a hip arthroplasty
  5. Have active cancer or recent, unexplained weight loss
  6. Report being blind
  7. Report being pregnant
  8. Report current or pending litigation related to back pain
  9. Currently be taking narcotic medication
  10. 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).

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): NCT02301741


Locations
Layout table for location information
United States, Ohio
Ohio University
Athens, Ohio, United States, 45701
Sponsors and Collaborators
Ohio University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ohio University
ClinicalTrials.gov Identifier: NCT02301741     History of Changes
Other Study ID Numbers: R21AR064430-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016

Keywords provided by Ohio University:
chronic low back pain

Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms