Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE February 4, 2016
First Posted Date  ICMJE February 10, 2016
Last Update Posted Date February 10, 2016
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2016)
  • 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)
  • 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")
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2016)
  • 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)
  • 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").
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 6, 2016)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Virtual Reality and Pain Perception During Exercises for Patients With Chronic Non-specific Low Back Pain
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE
  • Other: Virtual reality exercise group
  • Other: Conventional exercise group (control group)
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Other: Conventional exercise group (control group)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 6, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2016
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02679300
Other Study ID Numbers  ICMJE TMatheveVR&Pain
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Matheve, Hasselt University
Study Sponsor  ICMJE Hasselt University
Collaborators  ICMJE Jessa Hospital
Investigators  ICMJE Not Provided
PRS Account Hasselt University
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP