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

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679300
• Other study ID #: TMatheveVR&Pain
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: September 2018

Study information

• Verified date: June 2020
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• Virtual reality exercise group

• Conventional exercise group (control group)

Locations

Country	Name	City	State
Belgium	Hasselt University	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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