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

Chronic Low Back Pain Clinical Trial

— VIGOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463824
• Other study ID #: HM20014058
• Secondary ID: 1R01HD088417-01A
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: October 14, 2023

Study information

• Verified date: February 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: October 14, 2023
• Est. primary completion date: October 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Fear of Injury
• Fear of Pain
• Low Back Pain

Intervention

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 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).

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Ohio University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in Pain Vulnerability	Tampa Scale for Kinesiophobia, Pain Catastrophizing Scale	Baseline 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Other	Change in Pain Resilience	Pain Resilience Scale, Pain Self Efficacy Questionnaire	Baseline 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Other	Participant's Perception of Change as Function of Intervention	Patient Global Impression of Change	6-, 12-, 24-, and 48-weeks post-treatment
Other	Change in Pain Interference with Physical Function	Brief Pain Inventory, Roland Morris Disability Questionnaire	Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Other	Participant Evaluation of the Treatment	Treatment Evaluation Inventory	Baseline and 1-week post-treatment
Primary	Change in Pain	Numerical Pain Rating Score	Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Primary	Change in Disability	Roland Morris Disability Questionnaire	Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Secondary	Change in Lumbar Spine Flexion	Standardized Reaching Paradigm	Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Secondary	Change in Pain & Harm Expectancy	Standardized Reaching Paradigm	Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Secondary	Change in Real World Activity	Activity Monitor	Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment

External Links

•   The VIGOR Study