Virtual Reality and Pain Perception During Exercises for Patients With Chronic Non-specific Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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The Influence of a Virtual Reality Environment on Pain Perception During Exercises for Patients With Chronic Non-specific Low Back Pain: A Randomized Controlled Trial

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: Virtual reality exercise group
* Other: Conventional exercise group (control group)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic non-specific low back pain, with or without referred pain to the legs Age 18-65 Able to understand Dutch A minimum pain intensity of 3/10 on the numeric pain rating scale at the time of the test Being familiar with pelvic tilt exercises Exclusion Criteria: Spinal surgery in the past Pregnancy Serious underlying pathologies (e.g. multiple sclerosis, tumors,…) Signs or symptoms of nerve root involvement Known skin-allergy for tape

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality group<br>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<br> <br> |
| Active Comparator: Control group<br>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)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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). | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Low Back Pain, Virtual Reality, Serious Gaming, Exercise Therapy, Distraction