Feasibility, Acceptability, and Usability of a Tele-rehabilitation Combining Immersive Virtual Reality Exercises and Therapeutic Education for Chronic Non-specific Neck Pain

NCT05919953 | Completed

• 1 other identifier: VR NECK PAIN 2
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Keywords

Virtual reality; Therapeutic education; Tele-rehabilitation; Remote rehabilitation

Outcome Measures

Primary Outcomes (7)

• Feasibility of the intervention (retention rate)

  Retention rate (i.e., percentage of participants who completed the study).

  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).

  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).

  During the intervention (6 weeks)

• Feasibility of the intervention (implementation at home)

  Implementation of the intervention at home (assessed during the semi-structured interview).

  At the end of the intervention (at 6 weeks)

• Feasibility of the intervention (online consultations)

  Number and duration of the online consultations.

  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.

  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.

  At the end of the intervention (at 6 weeks)

Secondary Outcomes (7)

• Change in range of motion

  Pre-intervention and at the end of the intervention (at 6 weeks)

• Change in neck disability

  Pre-intervention and at the end of the intervention (at 6 weeks)

• Change in pain intensity

  Pre-intervention and at the end of the intervention (at 6 weeks)

• Change in kinesiophobia

  Pre-intervention and at the end of the intervention (at 6 weeks)

• Change in illness perception

  Pre-intervention and at the end of the intervention (at 6 weeks)

Study Arms (1)

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.

Device: Virtual reality; Behavioral: Therapeutic education

Interventions

Virtual reality DEVICE

Immersive virtual reality neck exercises targeting relaxation, mobility, control, and speed of movement, using the Pico G2 4K headset.

Virtual reality and therapeutic education

Therapeutic education BEHAVIORAL

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.

Virtual reality and therapeutic education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• Fonds National de la Recherche Scientifique: collaborator

Study Sites (1)

Université Catholique de Louvain

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent Pitance, PhD

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

• Gaëtan Stoquart, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 27, 2023
• Study Start: June 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)