An interventional study of Virtual reality exercise group and Conventional exercise group (control group) in Chronic Low Back Pain, sponsored by Hasselt University. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-22.
Sponsored by Hasselt University · Not applicable, Interventional, and Other
Immersion in a virtual reality environment has been shown to reduce pain during a variety of painful medical procedures, such as wound care for burn patients and dental care. Often, serious games are used to distract patients from this painful procedures. Recently, serious games have also been developed for patients with low back pain. Because patients with low back pain frequently experience pain during exercises, the investigators hypothesize that exercising with serious games can reduce the pain intensity and the time spent thinking of pain during exercises. To test this hypothesis, the investigators will conduct a randomized controlled trial where two groups will be compared: the experimental group will perform one session of exercises with serious games, while the control group will perform one session of the same exercises without the serious games.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 84 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
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Exclusion Criteria:
During a single intervention session, participants will perform 2 sets of 2 minutes of pelvic tilt exercises using serious games. These serious games have to be controlled by pelvic tilts. Patients will perform the exercises in a standing position in front a TV-screen, on which the games will be displayed. Wireless motion sensors will be mounted to the patient's spine and pelvis to track the movements of the pelvis.
Other: Virtual reality exercise group
During a single session intervention, participants will perform 2 sets of 2 minutes of pelvic tilt exercises without a serious game. Patients will perform the exercises in a standing position. The number of repetitions and the tempo of the pelvic tilts will be indicated using a metronome.
Other: Conventional exercise group (control group)
Average pain intensity during exercises using the numeric pain rating scale
Immediately after the intervention, patients will be asked to indicate the average pain they experienced during the exercises using the numeric pain rating scale (0-10)
Time frame: Day 1
Time spent thinking of the pain using a numeric rating scale
Immediately after the intervention, patients will be asked to indicate the average time they spent thinking of their pain during the exercises using a numeric rating scale ranging from 0 ("not at all") to 10 ("all the time")
Time frame: Day 1
Pain intensity after the exercises using a numeric rating scale
Patients will be asked to indicate their pain immediately after the exercises using the numeric pain rating scale (0-10)
Time frame: Day 1
Harmfulness of the exercises using a numeric rating scale
Immediately after the intervention, patients will be asked to indicate how harmful they thought the exercises were for their lumbar spine on a numeric rating scale ranging from 0 ("not harmful at all") to 10 ("extremely harmful").
Time frame: Day 1
Number of pelvic tilts
During the exercises the pelvis and lumbar spine of the participants will be recorded with a digital videocamera to capture the number of pelvic tilts during the exercises. This outcome measure will primarily be used as possible covariate
Time frame: Day 1
Immersion (questionnaire will be used to measure the level of immersion)
Immediately after the intervention, the immersive experience questionnaire will be used to measure the level of immersion
Time frame: Day 1
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Hasselt University