Clinical trial NCT06832748: Neck Movement Training in a Virtual Reality Headset for People with Neck Pain - a Feasibility Study
Official title: Feasibility of a Virtual Reality Based Sensorimotor Training Intervention for Patients with Chronic Traumatic Neck Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neck Pain
Keywords: neck pain
virtual reality
VR
sensorimotor training
pilot RCT
endurance training
whiplash injuries
feasibility studies
randomized controlled trial
Lead sponsor: Luleå Tekniska Universitet
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a feasibility study and pilot randomized controlled trial (RCT). The study will gain knowledge of feasibility of the intervention before a future full scale RCT. The study has a quantitative part to assess the feasibility of the VR-intervention, and to obtain initial measures of possible intervention effects for future sample size calculation when compared to a more traditional rehab intervention. It has also a qualitative part including interviews with the participants in the VR-group.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if a virtual reality (VR) intervention for people with chronic neck pain is feasible. The main questions it aims to answer are:

Is it possible to perform a future full-scale randomized controlled trial (RCT) with a remotely supervised VR-based intervention for people with chronic neck pain?

How do people with neck pain experience using VR in a home-based training intervention?

Researchers will investigate if aspects of a full-scale RCT is feasible. This includes how well the recruitment of participants worked, retention during the intervention, compliance to training program, adverse events, and experience using the VR during training. The study will also investigate initial indication of benefit of the VR intervention, such as effects on pain and function.

Participants will be randomly assigned to either a VR neck training group or an endurance training group. Both groups will perform a training program for 8 weeks with weekly follow ups with their physiotherapist via online meetings.

Detailed description: Title: Feasibility of a Virtual Reality-Based Sensorimotor Training Intervention for Patients with Chronic Traumatic Neck Pain

Background: Neck pain is very common, leading to reduced function and quality of life, and is costly for healthcare and society due to sick leave and productivity loss. The cause of neck pain is often unclear, with no visible structural damage. Persistent neck pain (lasting more than 3 months) and recurrent episodes are complex and not fully understood. Research suggests impaired sensorimotor control as a contributing factor.

Sensorimotor control involves neck movement control, awareness of head position, quick reaction to stimuli, and good neck mobility. These functions are crucial for daily activities (e.g., moving our body, riding a bike, driving a car), and maintaining body stability. Research has shown that these functions often are impaired in people with neck pain. Training these functions can reduce pain and improve function.

Virtual Reality (VR) technology, especially VR headsets, allows objective assessment of neck sensorimotor functions, crucial for personalized training to reduce pain and improve function. VR can measure movement velocity and reaction time, previously only possible with advanced lab equipment. VR can be used in clinics and at home, showing high accuracy in assessing neck functions. It may also make training enjoyable, potentially improving adherence.

Aim: This study aims to assess the feasibility of a future large-scale randomized controlled trial (RCT) using a VR-based training program for chronic neck pain patients. It will explore various feasibility aspects to plan a well-conducted RCT and examine participants' experiences with VR. Aspects include participant recruitment, adherence to intervention, study protocol feasibility, experience of VR based intervention, and initial effects on pain and function. Data will also help calculate the required sample size for a future RCT.

Method: The study is a pilot RCT with 20 participants randomized into two groups: VR training or endurance training. A stratified randomization to get equal number of women/men in each group will be performed through a randomization program. Both groups will train at home for 8 weeks with digital follow-ups from a physiotherapist.

There will be 2 qualified physiotherapists, each treating 10 patients (5 in each group). The physiotherapists have solid clinical experience from primary health care. They have experience treating people with neck pain and prescribing sensorimotor exercises. The physiotherapists will conduct baseline and post-treatment measures of outcome variables. They will not be blinded to treatment allocation.

Patients and physiotherapists will not be blinded to treatments due to the interventions being self-revealing.

After the intervention, VR group participants will be interviewed about their VR experience.

Participants: The study will include individuals with chronic neck pain (lasting more than 3 months) caused or worsened by trauma (e.g., car accidents, falls).

Outcome: The study will result in two publications: one on quantitative feasibility data, and another on qualitative feasibility data (patient interviews).

Eligibility criteria: Inclusion Criteria:

* Ability to understand verbal and written Swedish
* Persistent neck pain (\>3 months)
* Neck pain onset (or acute worsening) in relation to trauma to the head or neck
* Neck disability index 20-60% or Numeric Rating Scale neck pain ≥ 3/10
* Impaired sensorimotor function of the neck (at least one of the sensorimotor tests must be impaired, i.e. below the norm values for the test in question). The following cut-off values are used:

Joint position sense test: \> 4.5° absolute error in any of the four directions right rotation, left rotation, extension or flexion.

Movement sense test: \>28 seconds to complete the zigzag pattern, or \<2,5 norm value (i.e., accuracy in percentage divided by time in seconds).

Maximum velocity from the cervical reaction acuity test: \< 100°/s. Range of motion in right rotation, left rotation, extension and flexion (added together): \< 300°.

Exclusion Criteria:

* Cervical radiculopathy
* Neck surgery
* Fracture of the neck
* Neurological disease
* Vestibular disease
* Rheumatic disease
* Concussion where the person lost consciousness
* Uncorrected visual impairment
* Epilepsy
* Previous experience of severe symptoms (nausea/dizziness) when using VR headsets

Primary outcomes:
measure: Feasibility - Recruitment time (weeks)
timeFrame: From enrollment to end of treatment (at 8 weeks)
measure: Feasibility - Recruitment method
timeFrame: From enrollment to end of treatment (at 8 weeks)
measure: Feasibility - Adherence
timeFrame: Start of intervention to end of intervention at 8 weeks.
measure: Feasibility - Completion rate (drop out)
timeFrame: Start of intervention to end of intervention at 8 weeks.
measure: Feasibility - Outcome measure completion rate
timeFrame: At 8 weeks
measure: Feasibility - Adverse events
timeFrame: From start of intervention to 8 weeks
measure: Feasibility - Numeric Rating Scale (NRS) Simulator sickness intensity
timeFrame: Baseline and at end of intervention (at 8 weeks).
measure: Feasibility - Participants experience using VR in neck training - Qualitative part
timeFrame: After completion of the 8 weeks VR-intervention, approximately within 2 weeks after completion.
Secondary outcomes:
measure: Cervical joint position sense (JPS) test (performed in the VR headset)
timeFrame: Baseline and at end of intervention (at 8 weeks)
measure: Cervical reaction acuity (CRA) test - Reaction time milliseconds (performed in the VR headset)
timeFrame: Baseline and at end of intervention (at 8 weeks)
measure: Cervical reaction acuity (CRA) test - Maximum velocity. (performed in the VR headset)
timeFrame: Baseline and at end of intervention (at 8 weeks)
measure: Cervical reaction acuity (CRA) test - Time to complete the task. (performed in the VR headset)
timeFrame: Baseline and at end of intervention (at 8 weeks)
measure: Cervical movement sense test (performed in the VR headset)
timeFrame: Baseline and at end of intervention (at 8 weeks)
measure: Cervical range of motion test (performed in the VR headset)
timeFrame: Baseline and at end of intervention (at 8 weeks)
measure: Postural sway in quiet stance (performed with the VR headset)
timeFrame: Baseline and at end of intervention (at 8 weeks)
measure: Cervical flexion endurance test
timeFrame: Baseline and at end of intervention (at 8 weeks)
measure: Neck Disability Index (NDI)
timeFrame: Baseline and at end of intervention (at 8 weeks)
measure: Numeric Rating Scale (NRS) neck pain
timeFrame: Baseline and at end of intervention (at 8 weeks)
measure: Numeric Rating Scale (NRS) dizziness
timeFrame: Baseline and at end of intervention (at 8 weeks)
measure: Numeric Rating Scale (NRS) headache
timeFrame: Baseline and at end of intervention (at 8 weeks)
measure: EQ-5D-5L
timeFrame: Baseline and at end of intervention (at 8 weeks)
measure: Tampa scale of kinesiophobia -short version 11 item (TSK-11)
timeFrame: Baseline and at end of intervention (at 8 weeks)
measure: Global perceived effect (GPE)
timeFrame: At end of intervention (at 8 weeks)
measure: Feasibility - Physiotherapists experience of the VR intervention- Measured with a questionnaire.
timeFrame: After all participants have completed post intervention assessments at the end of the intervention (at 8 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Luleå University of Technology. Department of Health, Education and Technology
name: Ulrik Röijezon, Professor
role: STUDY_CHAIR
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