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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Virtual reality exercise group
Conventional exercise group (control group)
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Low Back Pain focused on measuring Chronic Low Back Pain, Virtual Reality, Serious Gaming, Exercise Therapy, Distraction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hasselt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual reality group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 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")

Secondary Outcome Measures

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)
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").

Full Information

First Posted
February 4, 2016
Last Updated
June 18, 2020
Sponsor
Hasselt University
Collaborators
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02679300
Brief Title
Virtual Reality and Pain Perception During Exercises for Patients With Chronic Non-specific Low Back Pain
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 Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Chronic Low Back Pain, Virtual Reality, Serious Gaming, Exercise Therapy, Distraction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Virtual reality exercise group
Intervention Type
Other
Intervention Name(s)
Conventional exercise group (control group)
Primary Outcome Measure Information:
Title
Average pain intensity during exercises using the numeric pain rating scale
Description
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
Title
Time spent thinking of the pain using a numeric rating scale
Description
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
Secondary Outcome Measure Information:
Title
Pain intensity after the exercises using a numeric rating scale
Description
Patients will be asked to indicate their pain immediately after the exercises using the numeric pain rating scale (0-10)
Time Frame
Day 1
Title
Harmfulness of the exercises using a numeric rating scale
Description
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
Other Pre-specified Outcome Measures:
Title
Number of pelvic tilts
Description
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
Title
Immersion (questionnaire will be used to measure the level of immersion)
Description
Immediately after the intervention, the immersive experience questionnaire will be used to measure the level of immersion
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hasselt University
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
32321516
Citation
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.
Results Reference
derived

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

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