Chronic Non-specific Neck PainNCT05244681
Experiences of a Home-based Virtual Reality Serious Game in People With Chronic Non-specific Neck Pain
A study testing Semi-structured interview in people with Chronic Non-specific Neck Pain, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Background: Immersive virtual reality (VR) has been used for several years in the treatment of chronic neck pain. This new type of rehabilitation device, which can be used at home, is promising and seems to be as effective as conventional treatments for neck pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Non-specific Neck Pain
- What is being tested?
- Semi-structured interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Mar 2022to 22 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (over 18 years), men or women, living in Belgium
- Chronic (> 3 months) non-specific neck pain (no specific cause responsible for the neck pain)
- To speak fluent French and to be able to provide informed consent to take part in an interview
- To be able to take part in a semi-structured interview
- No susceptibility to motion sickness, according to the Motion Sickness Susceptibility Questionnaire (MSSQ)
Who cannot join
- Age under 18 years
- Specific cause responsible for the neck pain (cancer, fracture, etc.)
- Signs of sensorimotor dysfunction (dizziness, vestibular disorders)
- Susceptibility to motion sickness, according to the MSSQ
- Vision problems
- Altered comprehension or inability to speak fluent French
- Inability to provide written informed consent or to take part in a semi-structured interview
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experiences of a Home-based Virtual Reality Serious Game in People With Chronic Non-specific Neck Pain: A Qualitative Study.
Background: Immersive virtual reality (VR) has been used for several years in the treatment of chronic neck pain. This new type of rehabilitation device, which can be used at home, is promising and seems to be as effective as conventional treatments for neck pain. Exploring the experience of people with chronic neck pain using this type of rehabilitation device at home could, among other things, help to understand the factors favoring good adherence and those not favoring it. This could also help us to improve VR home rehabilitation programs according to the patients' needs, preferences and expectations. However, currently, no studies have qualitatively evaluated the experience of people with chronic non-specific neck pain using an immersive VR serious game at home.
Objective: To explore the experience of people with chronic non-specific neck pain who used an immersive VR serious game at home.
Read more
Methods: Individual semi-structured interviews will be conducted with people with chronic non-specific neck pain. Interviews will last for approximately 30 to 60 minutes and will be carried out face-to-face or via videoconference (Microsoft Teams), depending on up-to-date guidance relating to the Covid-19 pandemic. Semi-structured interviews will be audio-recorded and transcribed verbatim. The transcripts will be read several times and analyzed using thematic analysis, with themes emerging from the transcripts (inductive approach). These themes will be defined and revised throughout the analysis process.
Discussion: Study findings will help to better understand the experience of people with chronic non-specific neck pain using a VR serious game at home, and then will allow to adapt it to the subjects' needs, preferences and expectations. These adaptations could further increase adherence to treatment and/or improve clinical outcomes for people with chronic non-specific neck pain using this type of rehabilitation device at home.
- Conditions
- Chronic Non-specific Neck Pain
- Being tested
- Semi-structured interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewOther
Semi-structured interview to explore the experience of people with chronic non-specific neck pain who used an immersive virtual reality serious game at home
| Study group | Role | What they receive |
|---|---|---|
| People with chronic non-specific neck pain | Other | Group of people with chronic non-specific neck pain who agreed to participate in a semi-structured interview about their experience using an immersive virtual reality serious game at home Receives: Other: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
General experience with the virtual reality serious game
Participants' responses based on the questions asked in the semi-structured interviews
Measured: 30-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start11 Mar 2022
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-specific Neck PainStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Responsible party
- Sponsor
- Investigators
- Christine Detrembleur, PhD, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244681
- Sponsor's protocol ID
- VR NECK PAIN
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences of a Home-based Virtual Reality Serious Game in People With Chronic Non-specific Neck Pain: A Qualitative Study.
- ClinicalTrials.gov ID
- NCT05244681
- Acronym / sponsor ID
- VR NECK PAIN
- Conditions
- Chronic Non-specific Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 17 Feb 2022 (actual)
- 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.
Background: Immersive virtual reality (VR) has been used for several years in the treatment of chronic neck pain. This new type of rehabilitation device, which can be used at home, is promising and seems to be as effective as conventional treatments for neck pain. Exploring the experience of people with chronic neck pain using this type of rehabilitation device at home could, among other things, help to understand the factors favoring good adherence and those not favoring it. This could also help us to improve VR home rehabilitation programs according to the patients' needs, preferences and expectations. However, currently, no studies have qualitatively evaluated the experience of people with chronic non-specific neck pain using an immersive VR serious game at home.
Objective: To explore the experience of people with chronic non-specific neck pain who used an immersive VR serious game at home.
Methods: Individual semi-structured interviews will be conducted with people with chronic non-specific neck pain. Interviews will last for approximately 30 to 60 minutes and will be carried out face-to-face or via videoconference (Microsoft Teams), depending on up-to-date guidance relating to the Covid-19 pandemic. Semi-structured interviews will be audio-recorded and transcribed verbatim. The transcripts will be read several times and analyzed using thematic analysis, with themes emerging from the transcripts (inductive approach). These themes will be defined and revised throughout the analysis process.
Discussion: Study findings will help to better understand the experience of people with chronic non-specific neck pain using a VR serious game at home, and then will allow to adapt it to the subjects' needs, preferences and expectations. These adaptations could further increase adherence to treatment and/or improve clinical outcomes for people with chronic non-specific neck pain using this type of rehabilitation device at home.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with chronic non-specific neck pain | Other | Other: Semi-structured interviewGroup of people with chronic non-specific neck pain who agreed to participate in a semi-structured interview about their experience using an immersive virtual reality serious game at home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (over 18 years), men or women, living in Belgium
- Chronic (> 3 months) non-specific neck pain (no specific cause responsible for the neck pain)
- To speak fluent French and to be able to provide informed consent to take part in an interview
- To be able to take part in a semi-structured interview
- No susceptibility to motion sickness, according to the Motion Sickness Susceptibility Questionnaire (MSSQ)
Key exclusion criteria (7 listed)
- Age under 18 years
- Specific cause responsible for the neck pain (cancer, fracture, etc.)
- Signs of sensorimotor dysfunction (dizziness, vestibular disorders)
- Susceptibility to motion sickness, according to the MSSQ
- Vision problems
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 |
|---|---|---|
| Semi-structured interviewSemi-structured interview to explore the experience of people with chronic non-specific neck pain who used an immersive virtual reality serious game at home | Other | People with chronic non-specific neck pain |
Primary outcome
General experience with the virtual reality serious game
Time frame: 30-60 minutes
Participants' responses based on the questions asked in the semi-structured interviews
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 28 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Christine Detrembleur, PhD principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-structured interview in people with Chronic Non-specific Neck Pain, run by Université Catholique de Louvain 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 7 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 28 Feb 2023. 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?
General experience with the virtual reality serious game (time frame: 30-60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2023.