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

NCT02679300 | Completed

• 1 other identifier: TMatheveVR&Pain
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

Chronic Low Back Pain; Virtual Reality; Serious Gaming; Exercise Therapy; Distraction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pain intensity after the exercises using a numeric rating scale

  Day 1

• Harmfulness of the exercises using a numeric rating scale

  Day 1

Other Outcomes (2)

• Number of pelvic tilts

  Day 1

• Immersion (questionnaire will be used to measure the level of immersion)

  Day 1

Study Arms (2)

Virtual reality group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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)

Interventions

Virtual reality exercise group OTHER

Virtual reality group

Conventional exercise group (control group) OTHER

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (1)

Hasselt University

Hasselt, 3500, Belgium

Location

Related Publications (1)

• 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.

  PMID: 32321516 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 10, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 22, 2020

Record last verified: 2020-06

Locations

BE (1)