Clinical trial NCT05919953: Feasibility, Acceptability, and Usability of a Tele-rehabilitation Combining Immersive Virtual Reality Exercises and Therapeutic Education for Chronic Non-specific Neck Pain
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Virtual reality
Therapeutic education
Tele-rehabilitation
Remote rehabilitation
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Fonds National de la Recherche Scientifique
First posted: 2023-06-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of the intervention (retention rate)
timeFrame: At the end of the intervention (at 6 weeks)
measure: Feasibility of the intervention (adhesion)
timeFrame: During the intervention (6 weeks)
measure: Feasibility of the intervention (safety)
timeFrame: During the intervention (6 weeks)
measure: Feasibility of the intervention (implementation at home)
timeFrame: At the end of the intervention (at 6 weeks)
measure: Feasibility of the intervention (online consultations)
timeFrame: At the end of the intervention (at 6 weeks)
measure: Acceptability (satisfaction) of the tele-rehabilitation
timeFrame: At the end of the intervention (at 6 weeks)
measure: Usability of the virtual reality system and the online consultations
timeFrame: At the end of the intervention (at 6 weeks)
Secondary outcomes:
measure: Change in range of motion
timeFrame: Pre-intervention and at the end of the intervention (at 6 weeks)
measure: Change in neck disability
timeFrame: Pre-intervention and at the end of the intervention (at 6 weeks)
measure: Change in pain intensity
timeFrame: Pre-intervention and at the end of the intervention (at 6 weeks)
measure: Change in kinesiophobia
timeFrame: Pre-intervention and at the end of the intervention (at 6 weeks)
measure: Change in illness perception
timeFrame: Pre-intervention and at the end of the intervention (at 6 weeks)
measure: Global perceived effect
timeFrame: At the end of the intervention (at 6 weeks)
measure: Experiences of the intervention
timeFrame: At the end of the intervention (at 6 weeks)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Université Catholique de Louvain
Study officials:
affiliation: Université Catholique de Louvain
name: Laurent Pitance, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Gaëtan Stoquart, PhD
role: PRINCIPAL_INVESTIGATOR
References: