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

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ClinicalTrials.gov Identifier: NCT02679300
Recruitment Status : Unknown
Verified February 2016 by Thomas Matheve, Hasselt University.
Recruitment status was:  Recruiting
First Posted : February 10, 2016
Last Update Posted : February 10, 2016
Sponsor:
Collaborator:
Jessa Hospital
Information provided by (Responsible Party):
Thomas Matheve, Hasselt University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Other: Virtual reality exercise group Other: Conventional exercise group (control group) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : January 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. Average pain intensity during exercises using the numeric pain rating scale [ Time Frame: Day 1 ]
    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)

  2. Time spent thinking of the pain using a numeric rating scale [ Time Frame: Day 1 ]
    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")


Secondary Outcome Measures :
  1. Pain intensity after the exercises using a numeric rating scale [ Time Frame: Day 1 ]
    Patients will be asked to indicate their pain immediately after the exercises using the numeric pain rating scale (0-10)

  2. Harmfulness of the exercises using a numeric rating scale [ Time Frame: Day 1 ]
    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").


Other Outcome Measures:
  1. Number of pelvic tilts [ Time Frame: Day 1 ]
    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

  2. Immersion (questionnaire will be used to measure the level of immersion) [ Time Frame: Day 1 ]
    Immediately after the intervention, the immersive experience questionnaire will be used to measure the level of immersion



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679300


Contacts
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Contact: Thomas Matheve +0032 (11) 292129 Thomas.Matheve@uhasselt.be

Locations
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Belgium
Hasselt University Recruiting
Hasselt, Belgium, 3500
Contact: Annick Timmermans, PhD    +32 (11) 292125    Annick.Timmermans@uhasselt.be   
Sponsors and Collaborators
Hasselt University
Jessa Hospital

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Responsible Party: Thomas Matheve, PT, MSc, Hasselt University
ClinicalTrials.gov Identifier: NCT02679300     History of Changes
Other Study ID Numbers: TMatheveVR&Pain
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Keywords provided by Thomas Matheve, Hasselt University:
Chronic Low Back Pain
Virtual Reality
Serious Gaming
Exercise Therapy
Distraction
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms