Neck Movement Training in a Virtual Reality Headset for People with Neck Pain - a Feasibility Study

Not Applicable

Not yet recruiting

• Conditions: Neck Pain

• Registration Number: NCT06832748
• Lead Sponsor: Luleå Tekniska Universitet

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).

Study Timeline

• Study First Submitted: 2025-01-31
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-12
• Last Update Submitted: 2025-02-12
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18
• Study Start: 2025-03
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility - Recruitment time (weeks)	From enrollment to end of treatment (at 8 weeks)	Time taken to recruit 20 participants. This will be measured in number of weeks.
Feasibility - Recruitment method	From enrollment to end of treatment (at 8 weeks)	Which recruitment channels were effective to find participants? (physiotherapy clinics, social media channels, newspaper advertisement, other). This will be measured by asking the participants.
Feasibility - Adherence	Start of intervention to end of intervention at 8 weeks.	Adherence rate to interventions. For the VR training group this is evaluated from the VR online portal training log. For the endurance training group this is evaluated from training diaries. This will be measured by number of completed training sessions and presented as percentage of prescribed dosage. A minimum of 70 % completed training sessions is considered acceptable.; Adherence feasibility criteria: ≥ 70% Proceed, 60-69% Proceed with changes, \<60% Do not proceed
Feasibility - Completion rate (drop out)	Start of intervention to end of intervention at 8 weeks.	Number of participants completing the intervention. Intervention completion rate feasibility criteria: ≥ 85% proceed, 70-85% proceed with changes, \<70% do not proceed.
Feasibility - Outcome measure completion rate	At 8 weeks	Obtained outcome measures from participants completing the intervention. Outcome measure completion rate criteria: ≥ 85% Proceed, 70-85% Proceed with changes, \<70% Do not proceed
Feasibility - Adverse events	From start of intervention to 8 weeks	Number of adverse events and what character. Treating physiotherapists will record any adverse events during the intervention period.
Feasibility - Numeric Rating Scale (NRS) Simulator sickness intensity	Baseline and at end of intervention (at 8 weeks).	Sickness intensity measured by the eleven-point Numeric Rating Scale (NRS), 0-10. The participants rate their sickness intensity right after completion of the test protocol, from no sickness (0) to worst imaginable sickness (10).
Feasibility - Participants experience using VR in neck training - Qualitative part	After completion of the 8 weeks VR-intervention, approximately within 2 weeks after completion.	Participants experience using VR in the 8-week intervention. This information will be obtained from semi-structured interviews, e.g., questions about usability, digitally delivered intervention, video consultations with physiotherapists, information and support, pros and cons of intervention.

Secondary Outcome Measures

Name	Time	Method
Cervical joint position sense (JPS) test (performed in the VR headset)	Baseline and at end of intervention (at 8 weeks)	Cervical JPS test assessed in the VR headset. The JPS test assesses the ability to sense the position of the neck and head (part of proprioception).; With a dark VR screen (imitating being blindfolded), the task is to find neutral head position, perform a head movement, and reposition the head back to the neutral position as accurately as possible. The test is performed with 6 repetitions i right rotation, left rotation, extension and flexion respectively. The error from starting position to end position is measured in degrees. Absolute error is calculated as outcome measure.
Cervical reaction acuity (CRA) test - Reaction time milliseconds (performed in the VR headset)	Baseline and at end of intervention (at 8 weeks)	CRA test assessed in the VR headset. A ball on the VR screen will move from the center to a random location. The task is to follow the ball as quickly as possible by moving the head to the center of the ball and staying in the center until a time circle counts down. The ball appears in the middle again, the participant moves their head back there and the next attempt begins. This will be repeated in random directions for 8 repetitions. Reaction time is measured in milliseconds, and defined as the time from the movement of the ball to the participant reaching 5% of their maximum velocity.
Cervical reaction acuity (CRA) test - Maximum velocity. (performed in the VR headset)	Baseline and at end of intervention (at 8 weeks)	CRA test assessed in the VR headset. A ball on the VR screen will move from the center to a random location. The task is to follow the ball as quickly as possible by moving the head to the center of the ball and staying in the center until a time circle counts down. The ball appears in the middle again, the participant moves their head back there and the next attempt begins. This will be repeated in random directions for 8 repetitions. Maximum velocity per repetition is measured in degrees per seconds.
Cervical reaction acuity (CRA) test - Time to complete the task. (performed in the VR headset)	Baseline and at end of intervention (at 8 weeks)	CRA test assessed in the VR headset. A ball on the VR screen will move from the center to a random location. The task is to follow the ball as quickly as possible by moving the head to the center of the ball and staying in the center until a time circle counts down. The ball appears in the middle again, the participant moves their head back there and the next attempt begins. This will be repeated in random directions for 8 repetitions. Time to complete the task is measured in seconds.
Cervical movement sense test (performed in the VR headset)	Baseline and at end of intervention (at 8 weeks)	Cervical movement sense test assessed in the VR headset. With head movements, participant trace the lines of a zig zag pattern as accurately as possible to their self-chosen speed. Outcome measures are: * Accuracy in percentage representing the percentage of the time being on the line.; * Time to complete the task.; * Norm value (accuracy divided by time).
Cervical range of motion test (performed in the VR headset)	Baseline and at end of intervention (at 8 weeks)	Maximum cervical range of motion in degrees is assessed in the VR headset for; * right rotation; * left rotation; * extension; * flexion; * right lateral flexion; * left lateral flexion; * right diagonal extension; * left diagonal extension; * right diagonal flexion; * left diagonal flexion
Postural sway in quiet stance (performed with the VR headset)	Baseline and at end of intervention (at 8 weeks)	Postural sway assessed in the VR headset. Quiet stance with feet together and arms crossed over the chest. The task is to stand as still as possible for 30 seconds with eyes open and closed, respectively. Outcome measures are the total length of the sway path in cm and sway amplitude in cm in anterio-posterior and medio-lateral direction, respectively. Data will be normalized to the height of the person.
Cervical flexion endurance test	Baseline and at end of intervention (at 8 weeks)	The participant lies in supine position, legs bent to 90 degrees. The chin is flexed while lifting the head and neck to about 2.5 cm above the surface. The test leader places one hand on the surface just below the participant's occiput to feel when the participant loses lift.; The test ends if the participant touches the test leader's hand for more than one second or if the participant loses the flexion of the chin.; Outcome measures are seconds.
Neck Disability Index (NDI)	Baseline and at end of intervention (at 8 weeks)	A self-reported physical functioning questionnaire targeting pain intensity and how it interferes with daily activities. Maximum score is 50 where a higher score represents higher disability. The score is transformed to percentage, higher percentage representing higher disability.
Numeric Rating Scale (NRS) neck pain	Baseline and at end of intervention (at 8 weeks)	Pain intensity measured by the eleven-point Numeric Rating Scale (NRS), 0-10. The participants rate their average pain intensity the previous 7 days, from no pain (0) to worst imaginable pain (10).
Numeric Rating Scale (NRS) dizziness	Baseline and at end of intervention (at 8 weeks)	Dizziness intensity will be measured by the eleven-point Numeric Rating Scale (NRS), 0-10. The participants rate their average dizziness intensity the previous 7 days from 0=no dizziness to 10= worst imaginable dizziness.
Numeric Rating Scale (NRS) headache	Baseline and at end of intervention (at 8 weeks)	Headache intensity will be measured by the eleven-point Numeric Rating Scale (NRS), 0-10. The participants rate their average headache intensity the previous 7 days from 0=no headache to 10=worst imaginable headache.
EQ-5D-5L	Baseline and at end of intervention (at 8 weeks)	Euro Quality of life 5 Dimensions 5 Levels (EQ-5D-5L). This is a questionnaire measuring health related quality of life. It is made up of 5 questions concerning mobility, personal care, daily activities, pain and discomfort, and psychological function (anxiety/depression). Each question gives a score from 1-5 where 1 = no problem and 5 = major problems and gives a 5-digit score which relates to a health profile.
Tampa scale of kinesiophobia -short version 11 item (TSK-11)	Baseline and at end of intervention (at 8 weeks)	Fear of movement questionnaire. It consists of 11 items, 1-4-point scale, where a higher score represents higher fear of movement.
Global perceived effect (GPE)	At end of intervention (at 8 weeks)	The global perceived effect scale is used to measure how much the participants neck problem has changed since the start of the intervention. It is an 11-point scale where -5=Much worse 0=No change, and +5=Much better
Feasibility - Physiotherapists experience of the VR intervention- Measured with a questionnaire.	After all participants have completed post intervention assessments at the end of the intervention (at 8 weeks)	Treating physiotherapists' experience of carrying out the VR intervention is evaluated with a questionnaire. It contains questions targeting aspects of the VR intervention, such as delivering the intervention remotely, advantages and disadvantages compared to traditional treatment with patient visits at a clinic, and usability aspects. The questionnaire comprises of nine 9-point Likert-scale questions, where 1 represents "strongly disagree" and 9 represents "strongly agree". Higher number indicate a more positive rating. Two open questions are included for comments about pros and cons of the VR-technology.