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

NCT03463824 | Completed Results DMC

• 3 other identifiers: HM200140581R01HD088417-01A117-F-11
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Low Back Pain; Fear of Pain; Fear of Injury

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Experimental Group 2

EXPERIMENTAL

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

Behavioral: Experimental Group 2

Interventions

Experimental Group 1 BEHAVIORAL

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).

Control Group

Experimental Group 2 BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Ohio University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23222, United States

Location

Related Publications (1)

• 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.

  PMID: 29730393 DERIVED

Related Links

• The VIGOR Study

Results Point of Contact

• Title: Dr. James Thomas
• Organization: Virginia Commonwealth University

jthomas32@vcu.edu

740-591-1563

Study Officials

• James S Thomas, P.T., Ph.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. One is a control group and the other is the experimental.

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 13, 2018
• Study Start: January 10, 2019
• Primary Completion: October 14, 2023
• Study Completion: October 14, 2023
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)