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

Primary Purpose

Chronic Low Back Pain, Fear of Pain, Fear of Injury

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental Group 1
Experimental Group 2
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental Group 1

Experimental Group 2

Arm Description

Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions.

Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions.

Outcomes

Primary Outcome Measures

Change in Pain
Numerical Pain Rating Score
Change in Disability
Roland Morris Disability Questionnaire

Secondary Outcome Measures

Change in Lumbar Spine Flexion
Standardized Reaching Paradigm
Change in Pain & Harm Expectancy
Standardized Reaching Paradigm
Change in Real World Activity
Activity Monitor

Full Information

First Posted
February 13, 2018
Last Updated
April 7, 2023
Sponsor
Virginia Commonwealth University
Collaborators
Ohio University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03463824
Brief Title
The VIGOR Study - Virtual Immersive Gaming to Optimize Recovery in Low Back Pain
Acronym
VIGOR
Official Title
The VIGOR Study - Virtual Immersive Gaming to Optimize Recovery in Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
October 14, 2023 (Anticipated)
Study Completion Date
October 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Ohio University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Fear of Pain, Fear of Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group 1
Arm Type
Experimental
Arm Description
Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions.
Arm Title
Experimental Group 2
Arm Type
Experimental
Arm Description
Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions.
Intervention Type
Behavioral
Intervention Name(s)
Experimental Group 1
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Experimental Group 2
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Pain
Description
Numerical Pain Rating Score
Time Frame
Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Title
Change in Disability
Description
Roland Morris Disability Questionnaire
Time Frame
Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Secondary Outcome Measure Information:
Title
Change in Lumbar Spine Flexion
Description
Standardized Reaching Paradigm
Time Frame
Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Title
Change in Pain & Harm Expectancy
Description
Standardized Reaching Paradigm
Time Frame
Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Title
Change in Real World Activity
Description
Activity Monitor
Time Frame
Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Other Pre-specified Outcome Measures:
Title
Change in Emotional Functioning
Description
Life Fulfillment Scale, Center for Epidemiologic Studies - Depression, Profile of Mood States, Patient-Reported Outcomes Measurement Information System (Anxiety, Depression, Positive Affect, Meaning & Purpose)
Time Frame
Baseline 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Title
Change in Pain Vulnerability
Description
Tampa Scale for Kinesiophobia, Pain Catastrophizing Scale
Time Frame
Baseline 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Title
Change in Pain Resilience
Description
Pain Resilience Scale, Pain Self Efficacy Questionnaire
Time Frame
Baseline 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Title
Participant's Perception of Change as Function of Intervention
Description
Patient Global Impression of Change
Time Frame
6-, 12-, 24-, and 48-weeks post-treatment
Title
Change in Pain Interference with Physical Function
Description
Brief Pain Inventory, Roland Morris Disability Questionnaire
Time Frame
Baseline, 1-, 6-, 12-, 24-, and 48-weeks post-treatment
Title
Participant Evaluation of the Treatment
Description
Treatment Evaluation Inventory
Time Frame
Baseline and 1-week post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James S Thomas, P.T., Ph.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23222
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29730393
Citation
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.
Results Reference
derived
Links:
URL
https://movr.vcu.edu/participate/
Description
The VIGOR Study

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

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