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

NCT ID: NCT02679300

Last Updated: 2020-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual reality exercise group

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

Conventional exercise group (control group)

Intervention Type: OTHER

Interventions

Virtual reality exercise group

Intervention Type: OTHER

Conventional exercise group (control group)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Thomas Matheve

PT, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hasselt University

Hasselt, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 32321516 (View on PubMed)

Other Identifiers

TMatheveVR&Pain

Identifier Type: -

Identifier Source: org_study_id