Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chronic Low Back Pain
  • Fear of Injury
  • Fear of Pain
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will be randomly assigned to one of two intervention arms. Both intervention arms involve immersive video games that encourage participants to produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. The two groups are distinguished by the amount of lumbar flexion needed to achieve game objectives.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: The principal investigators, the statistician, and members of the data collection team will remain blinded to intervention assignment throughout the duration of the study. They will be given the identifying codes only at the end of the study when it is necessary to interpret the results. The un-blinded study coordinator, who is responsible for scheduling testing and treatment sessions, will serve to receive the study patients and escort them to the various testing and treatments sites to minimize the interaction between patients; however, the study coordinator will not participate in the assessments.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

Description

A fundamental clinical problem in individuals with chronic low back pain is the significant alteration in movement patterns that restrict lumbar spine motion. This restriction of lumbar motion is particularly evident in patients with kinesiophobia; that is, a fear of movement due to possible injury ...

A fundamental clinical problem in individuals with chronic low back pain is the significant alteration in movement patterns that restrict lumbar spine motion. This restriction of lumbar motion is particularly evident in patients with kinesiophobia; that is, a fear of movement due to possible injury or reinjury. For chronic back pain patients with kinesiophobia it is critical to develop an effective intervention to increase spine motion while minimizing concerns of pain and harm. Accordingly, we have developed a innovative video games that track whole-body motion and are designed to encourage spinal flexion while reducing concerns of pain and harm among individuals with low back pain. Our games have two distinct advantages. First, within this video game environment, visual feedback can be altered by changing the feedback gain of a given movement (e.g., the magnitude of a given joint movement could appear on screen as either larger or smaller than the actual movement). Thus, gain manipulation will result in progressively larger amounts of lumbar spine flexion during game play. Second, video games are potent distractors that can reduce attention to pain.

Tracking Information

NCT #
NCT03463824
Collaborators
  • Ohio University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: James S Thomas, P.T., Ph.D. Virginia Commonwealth University
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