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

Primary Purpose

Neck Pain

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Virtual reality
Therapeutic education
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neck Pain focused on measuring Virtual reality, Therapeutic education, Tele-rehabilitation, Remote rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Université Catholique de LouvainRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual reality and therapeutic education

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility of the intervention (retention rate)
Retention rate (i.e., percentage of participants who completed the study).
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).
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).
Feasibility of the intervention (implementation at home)
Implementation of the intervention at home (assessed during the semi-structured interview).
Feasibility of the intervention (online consultations)
Number and duration of the online consultations.
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.
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.

Secondary Outcome Measures

Change in range of motion
Cervical range of motion (CROM) will be assessed using the virtual reality headset.
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.
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.
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.
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.
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").
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,...).

Full Information

First Posted
May 4, 2023
Last Updated
June 15, 2023
Sponsor
Université Catholique de Louvain
Collaborators
Fonds National de la Recherche Scientifique
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1. Study Identification

Unique Protocol Identification Number
NCT05919953
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain
Collaborators
Fonds National de la Recherche Scientifique

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Virtual reality, Therapeutic education, Tele-rehabilitation, Remote rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality and therapeutic education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
Immersive virtual reality neck exercises targeting relaxation, mobility, control, and speed of movement, using the Pico G2 4K headset.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of the intervention (retention rate)
Description
Retention rate (i.e., percentage of participants who completed the study).
Time Frame
At the end of the intervention (at 6 weeks)
Title
Feasibility of the intervention (adhesion)
Description
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)
Title
Feasibility of the intervention (safety)
Description
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)
Title
Feasibility of the intervention (implementation at home)
Description
Implementation of the intervention at home (assessed during the semi-structured interview).
Time Frame
At the end of the intervention (at 6 weeks)
Title
Feasibility of the intervention (online consultations)
Description
Number and duration of the online consultations.
Time Frame
At the end of the intervention (at 6 weeks)
Title
Acceptability (satisfaction) of the tele-rehabilitation
Description
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)
Title
Usability of the virtual reality system and the online consultations
Description
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)
Secondary Outcome Measure Information:
Title
Change in range of motion
Description
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)
Title
Change in neck disability
Description
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)
Title
Change in pain intensity
Description
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)
Title
Change in kinesiophobia
Description
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)
Title
Change in illness perception
Description
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)
Title
Global perceived effect
Description
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)
Title
Experiences of the intervention
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Luc, MSc
Phone
+32479959115
Email
alexandre.luc@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Pitance, PhD
Organizational Affiliation
Université Catholique de Louvain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gaëtan Stoquart, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université Catholique de Louvain
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Vanacker, PhD
Phone
003227647980
Email
julie.vanacker@saintluc.uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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