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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Other: Virtual reality exercise group; Other: Conventional exercise group (control group)

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Hasselt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality group; 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
Active Comparator: Control 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)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Day 1

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital

Publications and helpful links

General Publications

• Matheve T, Bogaerts K, Timmermans A. Virtual reality distraction induces hypoalgesia in patients with chronic low back pain: a randomized controlled trial. J Neuroeng Rehabil. 2020 Apr 22;17(1):55. doi: 10.1186/s12984-020-00688-0.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: February 6, 2016
• First Posted (Estimate): February 10, 2016

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Virtual Reality; Chronic Low Back Pain; Exercise Therapy; Distraction; Serious Gaming
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: TMatheveVR&Pain