An interventional study of Virtual reality and Therapeutic education in Neck Pain, sponsored by Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by Université Catholique de Louvain · Not applicable, Interventional, and Other
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.
1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.
This study's enrollment of 14 is below the median of 52 across 1,004 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →Université Catholique de Louvain is the lead sponsor of 144 studies on the registry; 57 are open to participants now.
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Exclusion Criteria:
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.
Device: Virtual reality · Behavioral: Therapeutic education
Immersive virtual reality neck exercises targeting relaxation, mobility, control, and speed of movement, using the Pico G2 4K headset.
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.
Feasibility of the intervention (retention rate)
Retention rate (i.e., percentage of participants who completed the study).
Time frame: 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).
Time frame: 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).
Time frame: During the intervention (6 weeks)
Feasibility of the intervention (implementation at home)
Implementation of the intervention at home (assessed during the semi-structured interview).
Time frame: At the end of the intervention (at 6 weeks)
Feasibility of the intervention (online consultations)
Number and duration of the online consultations.
Time frame: 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.
Time frame: 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.
Time frame: At the end of the intervention (at 6 weeks)
Change in range of motion
Cervical range of motion (CROM) will be assessed using the virtual reality headset.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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").
Time frame: 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,...).
Time frame: At the end of the intervention (at 6 weeks)
Plan to share: No
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Université Catholique de Louvain