Chronic Low Back PainNCT02679300
Virtual Reality and Pain Perception During Exercises for Patients With Chronic Non-specific Low Back Pain
A study testing Virtual reality exercise group in people with Chronic Low Back Pain, run by Hasselt University at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Virtual reality exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Virtual reality exercise group, Conventional exercise group (control group)
- Keywords
- Chronic Low Back Pain, Virtual Reality, Serious Gaming, Exercise Therapy, Distraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality exercise groupOther
Conventional exercise group (control group)Other
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional exercise group (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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")
Measured: Day 1
Secondary outcomes (2)
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)
Measured: Day 1
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").
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Thomas Matheve, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679300
- Sponsor's protocol ID
- TMatheveVR&Pain
- Status last verified
- Jun 2020
- First submitted
- 4 Feb 2016
- Last updated
- 22 Jun 2020
- Results posted
- No
Publications
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.
PubMed 32321516
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02679300
- Acronym / sponsor ID
- TMatheveVR&Pain
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic Low Back Pain, Virtual Reality, Serious Gaming, Exercise Therapy, Distraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- Jan 2016
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality group | Experimental | Other: Virtual reality exercise groupDuring 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. |
| Control group | Active comparator | Other: Conventional exercise group (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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality exercise group | Other | Virtual reality group |
| Conventional exercise group (control group) | Other | Control group |
Primary outcome
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")
2 secondary outcomes
Pain intensity after the exercises using a numeric rating scale
Time frame: Day 1
Harmfulness of the exercises using a numeric rating scale
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Derived from this study: PubMed 32321516Matheve 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality exercise group in people with Chronic Low Back Pain, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average pain intensity during exercises using the numeric pain rating scale (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02679300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.