Neck PainNCT05919953
Feasibility, Acceptability, and Usability of a Tele-rehabilitation Combining Immersive Virtual Reality Exercises and Therapeutic Education for Chronic Non-specific Neck Pain
A study testing Virtual reality and Therapeutic education in people with Neck Pain, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Background: Several randomized controlled trials have already investigated the efficacy of virtual reality treatment for chronic neck pain, however no study to date has investigated multimodal tele-rehabilitation, combining both specific neck exercises in immersive virtual reality and therapeutic education, in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- Virtual reality and Therapeutic education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2023to 30 Aug 2024
- 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
- Chronic (> 3 months) non-specific neck pain (no specific cause responsible for the neck pain), with or without referred pain in the upper limbs or the head
- Neck Disability Index score greater than or equal to 5/50
- Numerical Pain Rating Scale score greater than or equal to 3/10 (average pain over the past week)
- To speak fluent French and to be able to provide informed consent
Who cannot join
- Age under 18 years
- Specific cause responsible for the neck pain (tumor/cancer, fracture, trauma, inflammatory disease, infection, compression or lesion of the spinal cord, surgery of the cervical spine, vascular pathology, neurological pathology, ligamentous lesion of the upper cervical spine, congenital disease of the cervical spine, chronic diffuse pain)
- Neck Disability Index score less than 5/50
- Numerical Pain Rating Scale score less than 3/10 (average pain over the past week)
- Signs of untreated sensorimotor dysfunction (vertigo, vestibular disorders/pathologies, etc.) that interfere with the use of virtual reality
- Visual problems (uncorrected myopia, limited vision after correction, eye surgery) that interfere with the use of virtual reality
- Altered comprehension, significant cognitive impairment, inability to speak French, deafness, pregnancy, inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Acceptability, and Usability of a Tele-rehabilitation Combining Immersive Virtual Reality Exercises and Therapeutic Education for Chronic Non-specific Neck Pain: A Mixed-methods Pilot Study.
Background: Several randomized controlled trials have already investigated the efficacy of virtual reality treatment for chronic neck pain, however no study to date has investigated multimodal tele-rehabilitation, combining both specific neck exercises in immersive virtual reality and therapeutic education, in subjects with chronic non-specific neck pain.
Objectives: The primary objective of this mixed-methods pilot study is to determine the feasibility, acceptability, and usability of tele-rehabilitation combining immersive virtual reality exercises and therapeutic education in people with chronic non-specific neck pain. Secondary objectives are: 1) to investigate changes in clinical outcomes (range of motion, pain intensity, neck disability, illness perceptions, kinesiophobia, impression of change) ; 2) to explore the subjects' experience of tele-rehabilitation.
Read more
Methods: The duration of the intervention will be 6 weeks, including 5 virtual reality sessions (15-20 minutes per session, without supervision of the physiotherapist) and 1 teleconsultation session with a physiotherapist (30 minutes per session) per week. Participants will be assessed quantitatively before and after the intervention, and qualitatively after the intervention.
Discussion: Study findings will provide evidence concerning the feasibility, acceptability, and usability of multimodal tele-rehabilitation for chronic non-specific neck pain, using immersive virtual reality. This study may strengthen the scientific evidence for the use of immersive virtual reality at home in the treatment of chronic non-specific neck pain.
- Conditions
- Neck Pain
- Being tested
- Virtual reality, Therapeutic education
- Keywords
- Virtual reality, Therapeutic education, Tele-rehabilitation, Remote rehabilitation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Immersive virtual reality neck exercises targeting relaxation, mobility, control, and speed of movement, using the Pico G2 4K headset.
Therapeutic educationBehavioural
Several brochures will be given to participants. These brochures will cover the general principles of pain, the persistence of pain, tips for managing chronic non-specific pain, and the use of immersive virtual reality in the rehabilitation of chronic non-specific neck pain.
The information provided in the brochures will be discussed with the physiotherapist during the teleconsultations in order to individualize the therapeutic education.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality and therapeutic education | Experimental | Multimodal tele-rehabilitation consisting of therapeutic education and immersive virtual reality neck exercises.
The duration of the intervention will be 6 weeks, including 5 virtual reality sessions (15-20 minutes per session, without supervision of the physiotherapist) and 1 teleconsultation session with a physiotherapist (30 minutes per session) per week.
In addition, participants will receive several brochures to read on their own (therapeutic education). These brochures will be discussed with the physiotherapist during the teleconsultations. Receives: Device: Virtual reality; Behavioral: Therapeutic education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention (retention rate)
Retention rate (i.e., percentage of participants who completed the study).
Measured: At the end of the intervention (at 6 weeks)
Feasibility of the intervention (adhesion)
Adhesion to treatment (i.e., percentage of exercise sessions completed in relation to the total number of sessions prescribed, as well as the duration and frequency of the sessions).
Measured: During the intervention (6 weeks)
Feasibility of the intervention (safety)
Safety (i.e., adverse events (type, frequency, severity) occurring during the intervention, assessed using a list of symptoms based on the Simulator Sickness Questionnaire and during the semi-structured interview).
Measured: During the intervention (6 weeks)
Feasibility of the intervention (implementation at home)
Implementation of the intervention at home (assessed during the semi-structured interview).
Measured: At the end of the intervention (at 6 weeks)
Feasibility of the intervention (online consultations)
Number and duration of the online consultations.
Measured: At the end of the intervention (at 6 weeks)
Acceptability (satisfaction) of the tele-rehabilitation
Satisfaction with the tele-rehabilitation (online consultations, weekly follow-up, virtual reality exercises,...) using 5-point Likert-scale questions (from "not at all satisfied" to "very satisfied") and during the semi-structured interview.
Measured: At the end of the intervention (at 6 weeks)
Usability of the virtual reality system and the online consultations
Usability of the virtual reality system and the online consultations (assessed via the System Usability Scale (SUS) questionnaire and during the semi-structured interview). The SUS is a 10-item self-reported questionnaire assessing the usability of the interactive systems. Each item is scored from 1 ("do not agree at all") to 5 ("completely agree"). The total score ranges from 0 to 100, and higher scores reflect higher usability.
Measured: At the end of the intervention (at 6 weeks)
Secondary outcomes (7)
Change in range of motion
Cervical range of motion (CROM) will be assessed using the virtual reality headset.
Measured: Pre-intervention and at the end of the intervention (at 6 weeks)
Change in neck disability
The Neck Disability Index (NDI) is a 10-item self-reported questionnaire assessing perceived neck disability by covering neck pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleep, and recreation. Each item is scored from 0 ("no disability") to 5 ("complete disability"). The total score ranges from 0 to 50, and higher scores reflect higher disability.
Measured: Pre-intervention and at the end of the intervention (at 6 weeks)
Change in pain intensity
The Numeric Pain Rating Scale (NPRS) is a 11-point numeric horizontal scale assessing pain intensity from 0 ("no pain") to 10 ("worst possible pain"). NPRS will be used to measure the average pain intensity of the previous 7 days.
Measured: Pre-intervention and at the end of the intervention (at 6 weeks)
Change in kinesiophobia
The Tampa Scale of Kinesiophobia (TSK) is a 17-item self-reported questionnaire used to assess kinesiophobia. Each item is scored from 1 ("strongly disagree") to 4 ("strongly agree"). The total score ranges from 17 to 68, and higher scores reflect increased kinesiophobia.
Measured: Pre-intervention and at the end of the intervention (at 6 weeks)
Change in illness perception
The Brief Illness Perception Questionnaire (BIPQ) is a 9-item self-reported questionnaire assessing the cognitive and emotional representations of illness, illness comprehensibility, and the three most important causal factors in the patients illness (open-ended question). Each item (except the open-ended question) is scored from 0 to 10, where higher scores indicate stronger perceptions along that dimension. The total score ranges from 0 to 80, and higher scores reflect more negative perceptions.
Measured: Pre-intervention and at the end of the intervention (at 6 weeks)
Global perceived effect
The Global Perceived Effect (GPE) will be assessed using a single 7-point Likert scale question about how the subject would describe him/herself in relation to before the intervention began (from 1 = "completely recovered" to 7 = "worse than ever").
Measured: At the end of the intervention (at 6 weeks)
Experiences of the intervention
Experiences will be investigated during semi-structured interviews. These interviews will address the intervention (challenges, benefits, adhesion to treatment,...) and the virtual reality system (equipment, virtual environments, games,...).
Measured: At the end of the intervention (at 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jun 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 14 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
- Laurent Pitance, PhD, Principal investigator, Université Catholique de LouvainGaëtan Stoquart, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919953
- Sponsor's protocol ID
- VR NECK PAIN 2
- Status last verified
- Dec 2024
- First submitted
- 4 May 2023
- Last updated
- 10 Dec 2024
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Usability of a Tele-rehabilitation Combining Immersive Virtual Reality Exercises and Therapeutic Education for Chronic Non-specific Neck Pain: A Mixed-methods Pilot Study.
- ClinicalTrials.gov ID
- NCT05919953
- Acronym / sponsor ID
- VR NECK PAIN 2
- Conditions
- Neck Pain
- Keywords
- Virtual reality, Therapeutic education, Tele-rehabilitation, Remote rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 27 Jun 2023 (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: Several randomized controlled trials have already investigated the efficacy of virtual reality treatment for chronic neck pain, however no study to date has investigated multimodal tele-rehabilitation, combining both specific neck exercises in immersive virtual reality and therapeutic education, in subjects with chronic non-specific neck pain.
Objectives: The primary objective of this mixed-methods pilot study is to determine the feasibility, acceptability, and usability of tele-rehabilitation combining immersive virtual reality exercises and therapeutic education in people with chronic non-specific neck pain. Secondary objectives are: 1) to investigate changes in clinical outcomes (range of motion, pain intensity, neck disability, illness perceptions, kinesiophobia, impression of change) ; 2) to explore the subjects' experience of tele-rehabilitation.
Methods: The duration of the intervention will be 6 weeks, including 5 virtual reality sessions (15-20 minutes per session, without supervision of the physiotherapist) and 1 teleconsultation session with a physiotherapist (30 minutes per session) per week. Participants will be assessed quantitatively before and after the intervention, and qualitatively after the intervention.
Discussion: Study findings will provide evidence concerning the feasibility, acceptability, and usability of multimodal tele-rehabilitation for chronic non-specific neck pain, using immersive virtual reality. This study may strengthen the scientific evidence for the use of immersive virtual reality at home in the treatment of chronic non-specific neck pain.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality and therapeutic education | Experimental | Device: Virtual reality, Behavioral: Therapeutic educationMultimodal tele-rehabilitation consisting of therapeutic education and immersive virtual reality neck exercises. The duration of the intervention will be 6 weeks, including 5 virtual reality sessions (15-20 minutes per session, without supervision of the physiotherapist) and 1 teleconsultation session with a physiotherapist (30 minutes per session) per week. In addition, participants will receive several brochures to read on their own (therapeutic education). These brochures will be discussed with the physiotherapist during the teleconsultations. |
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
- Chronic (> 3 months) non-specific neck pain (no specific cause responsible for the neck pain), with or without referred pain in the upper limbs or the head
- Neck Disability Index score greater than or equal to 5/50
- Numerical Pain Rating Scale score greater than or equal to 3/10 (average pain over the past week)
- To speak fluent French and to be able to provide informed consent
Key exclusion criteria (7 listed)
- Age under 18 years
- Specific cause responsible for the neck pain (tumor/cancer, fracture, trauma, inflammatory disease, infection, compression or lesion of the spinal cord, surgery of the cervical spine, vascular pathology, neurological pathology, ligamentous lesion of the upper cervical spine, congenital disease of the cervical spine, chronic diffuse pain)
- Neck Disability Index score less than 5/50
- Numerical Pain Rating Scale score less than 3/10 (average pain over the past week)
- Signs of untreated sensorimotor dysfunction (vertigo, vestibular disorders/pathologies, etc.) that interfere with the use of virtual reality
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 realityImmersive virtual reality neck exercises targeting relaxation, mobility, control, and speed of movement, using the Pico G2 4K headset. | Device | Virtual reality and therapeutic education |
| Therapeutic educationSeveral brochures will be given to participants. These brochures will cover the general principles of pain, the persistence of pain, tips for managing chronic non-specific pain, and the use of immersive virtual reality in the rehabilitation of chronic non-specific neck pain. The information provided in the brochures will be discussed with the physiotherapist during the teleconsultations in order to individualize the therapeutic education. | Behavioural | Virtual reality and therapeutic education |
Primary outcome
Feasibility of the intervention (retention rate)
Time frame: At the end of the intervention (at 6 weeks)
Retention rate (i.e., percentage of participants who completed the study).
Feasibility of the intervention (adhesion)
Time frame: During the intervention (6 weeks)
Adhesion to treatment (i.e., percentage of exercise sessions completed in relation to the total number of sessions prescribed, as well as the duration and frequency of the sessions).
Feasibility of the intervention (safety)
Time frame: During the intervention (6 weeks)
Safety (i.e., adverse events (type, frequency, severity) occurring during the intervention, assessed using a list of symptoms based on the Simulator Sickness Questionnaire and during the semi-structured interview).
Feasibility of the intervention (implementation at home)
Time frame: At the end of the intervention (at 6 weeks)
Implementation of the intervention at home (assessed during the semi-structured interview).
Feasibility of the intervention (online consultations)
Time frame: At the end of the intervention (at 6 weeks)
Number and duration of the online consultations.
Acceptability (satisfaction) of the tele-rehabilitation
Time frame: At the end of the intervention (at 6 weeks)
Satisfaction with the tele-rehabilitation (online consultations, weekly follow-up, virtual reality exercises,...) using 5-point Likert-scale questions (from "not at all satisfied" to "very satisfied") and during the semi-structured interview.
Usability of the virtual reality system and the online consultations
Time frame: At the end of the intervention (at 6 weeks)
Usability of the virtual reality system and the online consultations (assessed via the System Usability Scale (SUS) questionnaire and during the semi-structured interview). The SUS is a 10-item self-reported questionnaire assessing the usability of the interactive systems. Each item is scored from 1 ("do not agree at all") to 5 ("completely agree"). The total score ranges from 0 to 100, and higher scores reflect higher usability.
7 secondary outcomes
Change in range of motion
Time frame: Pre-intervention and at the end of the intervention (at 6 weeks)
Change in neck disability
Time frame: Pre-intervention and at the end of the intervention (at 6 weeks)
Change in pain intensity
Time frame: Pre-intervention and at the end of the intervention (at 6 weeks)
Change in kinesiophobia
Time frame: Pre-intervention and at the end of the intervention (at 6 weeks)
Change in illness perception
Time frame: Pre-intervention and at the end of the intervention (at 6 weeks)
Global perceived effect
Time frame: At the end of the intervention (at 6 weeks)
Experiences of the intervention
Time frame: At the end of the intervention (at 6 weeks)
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 10 Dec 2024.
- 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.
Laurent Pitance, PhD principal investigator
Université Catholique de Louvain
Gaëtan Stoquart, PhD principal investigator
Cliniques universitaires Saint-Luc- 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 Virtual reality and Therapeutic education in people with 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 10 Dec 2024. 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?
Feasibility of the intervention (retention rate) (time frame: At the end of the intervention (at 6 weeks)). The study lists 7 primary outcomes in all. 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 10 Dec 2024.