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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02301741
• Other study ID #: R21AR064430-01A1
• Status: Completed
• Phase: N/A
• First received: November 24, 2014
• Last updated: June 9, 2016
• Start date: January 2015
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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).

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline (day 1) to post-test (day 5)	No
Primary	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.	baseline (day 1) to post-test (day 5)	No
Primary	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.	baseline (day 1) to post-test (day 5)	No
Secondary	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.	session day 2, 3 and 4	No