Trial Outcomes & Findings for The VIGOR Study - Virtual Immersive Gaming to Optimize Recovery in Low Back Pain (NCT NCT03463824)

Last Updated: 2025-02-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

154 participants

Primary outcome timeframe

Baseline measure through the 48-weeks post-treatment measure

Results posted on

2025-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group 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. 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 produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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).
Overall Study STARTED	74	80
Overall Study COMPLETED	74	80
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Group 1 n=74 Participants Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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 n=80 Participants Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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).	Total n=154 Participants Total of all reporting groups
Age, Customized	37 years n=99 Participants	41.1 years n=107 Participants	39.05 years n=206 Participants
Sex: Female, Male Female	50 Participants n=99 Participants	50 Participants n=107 Participants	100 Participants n=206 Participants
Sex: Female, Male Male	24 Participants n=99 Participants	30 Participants n=107 Participants	54 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	14 Participants n=99 Participants	12 Participants n=107 Participants	26 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	25 Participants n=99 Participants	24 Participants n=107 Participants	49 Participants n=206 Participants
Race (NIH/OMB) White	35 Participants n=99 Participants	35 Participants n=107 Participants	70 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants
Region of Enrollment United States	74 participants n=99 Participants	80 participants n=107 Participants	154 participants n=206 Participants
Median BMI	29.9 kg/m^2 n=99 Participants	26.7 kg/m^2 n=107 Participants	28.3 kg/m^2 n=206 Participants
Radiating pain yes	52 Participants n=99 Participants	51 Participants n=107 Participants	103 Participants n=206 Participants
Radiating pain no	22 Participants n=99 Participants	29 Participants n=107 Participants	51 Participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline measure through the 48-weeks post-treatment measure

Population: Study participants who completed this procedure

Outcome measures

Outcome measures
Measure	Experimental Group 1 n=72 Participants Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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 n=78 Participants Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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).
Percent Change in Pain Reduction on The Numerical Pain Rating Scale (NPRS)	30.3 percentage change (NPRS) Standard Deviation 43.2	35.2 percentage change (NPRS) Standard Deviation 33

PRIMARY outcome

Timeframe: Baseline measurement through 48-weeks post-treatment measurement change

Population: Subjects that completed this procedure

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

Outcome measures

Outcome measures
Measure	Experimental Group 1 n=71 Participants Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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 n=77 Participants Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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).
Change in Disability Using the Roland Morris Disability Questionnaire	37 score on Roland Morris Disability Questi Standard Deviation 34.6	25 score on Roland Morris Disability Questi Standard Deviation 35.2

Adverse Events

Experimental Group 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Experimental Group 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental Group 1 n=74 participants at risk Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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 n=80 participants at risk Participants will produce progressively larger lumbar flexion excursions at each game level and across treatment sessions. 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).
General disorders A transient ischemic attack TIA	1.4% 1/74 • Number of events 1 • The data was collected at baseline through the end of the study procedures, baseline over 9 weeks.	0.00% 0/80 • The data was collected at baseline through the end of the study procedures, baseline over 9 weeks.
Musculoskeletal and connective tissue disorders Shoulder work injury	1.4% 1/74 • Number of events 1 • The data was collected at baseline through the end of the study procedures, baseline over 9 weeks.	0.00% 0/80 • The data was collected at baseline through the end of the study procedures, baseline over 9 weeks.
Musculoskeletal and connective tissue disorders Knee Bone Spurs	1.4% 1/74 • Number of events 1 • The data was collected at baseline through the end of the study procedures, baseline over 9 weeks.	0.00% 0/80 • The data was collected at baseline through the end of the study procedures, baseline over 9 weeks.
Musculoskeletal and connective tissue disorders micro-discectomy on L5-L5 and a laminectomy	1.4% 1/74 • Number of events 1 • The data was collected at baseline through the end of the study procedures, baseline over 9 weeks.	0.00% 0/80 • The data was collected at baseline through the end of the study procedures, baseline over 9 weeks.
Musculoskeletal and connective tissue disorders pulled a muscle in his left hip and lower back while changing a car tire	0.00% 0/74 • The data was collected at baseline through the end of the study procedures, baseline over 9 weeks.	1.2% 1/80 • Number of events 1 • The data was collected at baseline through the end of the study procedures, baseline over 9 weeks.
Musculoskeletal and connective tissue disorders back surgery prior to coming in for V2	0.00% 0/74 • The data was collected at baseline through the end of the study procedures, baseline over 9 weeks.	1.2% 1/80 • Number of events 1 • The data was collected at baseline through the end of the study procedures, baseline over 9 weeks.
Musculoskeletal and connective tissue disorders minor surgery and it turned out to be a major surgery	0.00% 0/74 • The data was collected at baseline through the end of the study procedures, baseline over 9 weeks.	1.2% 1/80 • Number of events 1 • The data was collected at baseline through the end of the study procedures, baseline over 9 weeks.

Additional Information

Dr. James Thomas

Virginia Commonwealth University

Phone: 740-591-1563

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place