The VIGOR Study - Virtual Immersive Gaming to Optimize Recovery in Low Back Pain (VIGOR)

This study will measure the effects of interactive, whole-body video games on movement behavior in people with chronic low back pain.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain; Fear of Pain; Fear of Injury
• Intervention / Treatment: Behavioral: Experimental Group 1; Behavioral: Experimental Group 2

Detailed 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 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.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23222
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-60 years of age
• Low back pain that has been ongoing for at least half the days in the last 6 months
• Average pain intensity of greater than 3 over the past week on a 0-10 Numerical Rating Scale
• Disability greater than 4 on Roland and Morris Disability Questionnaire
• Agrees with statement "It is not really safe for a person with my back problem to be physically active" or Tampa Scale of Kinesiophobia score greater than 36
• Has sought care or consultation from a health care provider for back pain
• Meets category 1, 2, or 3 on the Classification System of the Quebec Task Force on Spinal Disorders which reflects low back pain without neurological signs
• Working proficiency in English

Exclusion Criteria:

• Has a personal history of the following neurological disorders: Alzheimers, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinsons, Neuropathy, Stroke, Seizures
• Has a personal history of the following cardiorespiratory disorders: Congestive heart failure, heart attack in past 2 years
• Has a personal history of the following musculoskeletal disorders: Rheumatoid Arthritis, Muscular Dystrophy, pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis
• History of spine surgery or a hip arthroplasty
• Has active cancer
• Has a chronic disease that may restrict movement or preclude safe participation
• Has used opioids within 30 days prior to study enrollment
• Reports being pregnant, lactating, or that they anticipate becoming pregnant within 2-months
• Reports pending litigation related to CLBP
• Has current drug or alcohol use or dependence that, in the opinion of the PIs, would interfere with adherence to study requirements
• Has significant visual impairment that would prevent virtual reality headset use
• Has significant motion sickness that would prevent virtual reality headset use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group 2; Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions.	Behavioral: Experimental Group 2; Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9).
Active Comparator: Control Group; Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. The control group will play the same immersive video games, but the parameters will be modified such that only small excursions of lumbar flexion are needed to successfully complete gameplay.	Behavioral: Experimental Group 1; Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Pain Reduction on The Numerical Pain Rating Scale (NPRS)	The Numerical Pain Rating Scale (NPRS) is a pain assessment tool that uses a 11 point scale of 0-10 to help patients rate the intensity of their pain: 0: No pain and 10: The worst pain imaginable. The NPRS is the most commonly used unidimensional pain scale. It can be administered verbally or graphically, and patients are asked to select the number that best reflects their pain intensity over the past 24 hours. The smaller the number (closer to 0), the less pain the subject is enduring, and the larger the number, the more pain they are enduring. Percent change in NPRS rather than raw score change may provide more meaningful information regarding a patient's response to pain treatment.	Baseline measure through the 48-weeks post-treatment measure
Change in Disability Using the Roland Morris Disability Questionnaire	Roland Morris Disability Questionnaire: A patient taking the survey agrees or disagrees with these statements (Yes/No). The patient is asked to tick a statement when it applies to him that specific day, this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The items of the questionnaire are assessed on a 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability. The sum of the seven items equals the total score of the PDI, which ranges from 0 to 70, with higher scores (closer to 70) reflecting higher interference of pain with daily activities and a lower score (closer to 0) has less interference of pain with daily activities.. Test-retest reliability 24-item: intraclass correlation (ICC) ranges from 0.42 - 0.91 T	Baseline measurement through 48-weeks post-treatment measurement change

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lumbar Spine Flexion	Standardized Reaching Paradigm	Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Change in Pain & Harm Expectancy	Standardized Reaching Paradigm	Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Change in Real World Activity	Activity Monitor	Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Emotional Functioning	Life Fulfillment Scale, Center for Epidemiologic Studies - Depression, Profile of Mood States, Patient-Reported Outcomes Measurement Information System (Anxiety, Depression, Positive Affect, Meaning & Purpose)	Baseline 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Change in Pain Vulnerability	Tampa Scale for Kinesiophobia, Pain Catastrophizing Scale	Baseline 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Change in Pain Resilience	Pain Resilience Scale, Pain Self Efficacy Questionnaire	Baseline 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Participant's Perception of Change as Function of Intervention	Patient Global Impression of Change	6-, 12-, 24-, and 48-weeks post-treatment
Change in Pain Interference with Physical Function	Brief Pain Inventory, Roland Morris Disability Questionnaire	Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Participant Evaluation of the Treatment	Treatment Evaluation Inventory	Baseline and 1-week post-treatment

Collaborators and Investigators

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

Publications and helpful links

General Publications

• France CR, Thomas JS. Virtual immersive gaming to optimize recovery (VIGOR) in low back pain: A phase II randomized controlled trial. Contemp Clin Trials. 2018 Jun;69:83-91. doi: 10.1016/j.cct.2018.05.001. Epub 2018 May 3. Erratum In: Contemp Clin Trials. 2020 Sep;96:106120. doi: 10.1016/j.cct.2020.106120.

Helpful Links

• The VIGOR Study

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): October 14, 2023
• Study Completion (Actual): October 14, 2023

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: HM20014058; 1R01HD088417-01A1 (U.S. NIH Grant/Contract); 17-F-11 (Other Identifier: Ohio University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No