Clinical trial NCT02301741: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: chronic low back pain
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2014-11-26
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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).

Primary outcomes:
measure: Lumbar spine flexion changes
timeFrame: baseline (day 1) to post-test (day 5)
measure: Expectation of pain changes
timeFrame: baseline (day 1) to post-test (day 5)
measure: Expectation of harm changes
timeFrame: baseline (day 1) to post-test (day 5)
Secondary outcomes:
measure: Lumbar spine flexion change as a function of altered movement gain
timeFrame: session day 2, 3 and 4
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
References:
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.