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

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03463824
• Collaborator: Ohio University (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 230
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 50.1
• Patients Per Site Per Month: 4.6

Study Details

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	N/A

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
• Anticipated 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.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: Jan 10, 2019
• Anticipated Primary Completion Date: Mar 14, 2023
• Anticipated Study Completion Date: Mar 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 [Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment]

   Numerical Pain Rating Score

2. Change in Disability [Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment]

   Roland Morris Disability Questionnaire

Secondary Outcome Measures

1. Change in Lumbar Spine Flexion [Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment]

   Standardized Reaching Paradigm

2. Change in Pain & Harm Expectancy [Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment]

   Standardized Reaching Paradigm

3. Change in Real World Activity [Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment]

   Activity Monitor

Other Outcome Measures

1. Change in Emotional Functioning [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 [Baseline 1-, 6-, 12-, 24-, and 48-weeks post-treatment]

   Tampa Scale for Kinesiophobia, Pain Catastrophizing Scale

3. Change in Pain Resilience [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 [6-, 12-, 24-, and 48-weeks post-treatment]

   Patient Global Impression of Change

5. Change in Pain Interference with Physical Function [Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment]

   Brief Pain Inventory, Roland Morris Disability Questionnaire

6. Participant Evaluation of the Treatment [Baseline and 1-week post-treatment]

   Treatment Evaluation Inventory

Eligibility Criteria

Criteria

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

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT03463824
• Other Study ID Numbers: HM20014058; 1R01HD088417-01A1; 17-F-11
• First Posted: Mar 13, 2018
• Last Update Posted: Sep 23, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of Sep 23, 2021