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

• ClinicalTrials.gov Identifier: NCT03463824
• Recruitment Status: Active, not recruiting
• First Posted: March 13, 2018
• Last Update Posted: April 10, 2023
• Sponsor: Virginia Commonwealth University
• Collaborators: Ohio University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Virginia Commonwealth University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Chronic Low Back Pain; Fear of Pain; Fear of Injury	Behavioral: Experimental Group 1; Behavioral: Experimental Group 2	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 230 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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
• Official Title: The VIGOR Study - Virtual Immersive Gaming to Optimize Recovery in Low Back Pain
• Actual Study Start Date: January 10, 2019
• Estimated Primary Completion Date: October 14, 2023
• Estimated Study Completion Date: October 14, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental Group 1; Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions.	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).
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).

Outcome Measures

Primary Outcome Measures :

1. Change in Pain [ Time Frame: Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment ]
   Numerical Pain Rating Score
2. Change in Disability [ Time Frame: Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment ]
   Roland Morris Disability Questionnaire

Secondary Outcome Measures :

1. Change in Lumbar Spine Flexion [ Time Frame: Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment ]
   Standardized Reaching Paradigm
2. Change in Pain & Harm Expectancy [ Time Frame: Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment ]
   Standardized Reaching Paradigm
3. Change in Real World Activity [ Time Frame: Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment ]
   Activity Monitor

Other Outcome Measures:

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23222

Sponsors and Collaborators

Virginia Commonwealth University

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

More Information

Additional Information:

The VIGOR Study 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT03463824
• Other Study ID Numbers: HM20014058; 1R01HD088417-01A1 ( U.S. NIH Grant/Contract ); 17-F-11 ( Other Identifier: Ohio University )
• First Posted: March 13, 2018
• Last Update Posted: April 10, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations