Neck Movement Training in a Virtual Reality Headset for People with Neck Pain - a Feasibility Study
NCT ID: NCT06832748
Last Updated: 2025-02-18
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-03-31
2025-07-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VR neck training group (10 participants)
10 participants will use a VR headsets and perform training targeting the neck sensorimotor function. The patient interacts through head movements, and perform tasks in the VR environment.
VR neck training
VR intervention 8 weeks. A VR headset is used for assessment and training of sensorimotor functions of the neck. The VR headset has a built-in sensor which can measure movements and give objective test and training results. The results serve as a guide for tailored home-based training programs, also performed with the VR headset in the experimental group. The participant performs the training at home, 15-20 minutes/day 5 days/week, initiallay divided into 3 sessions of 5 minutes each, while progression may lead to longer but fewer sessions. The program is individually tailored to target specific sensorimotor disturbances, and progressed during the intervention to increase the challenge. Participants will have video consultations with their physiotherapist once a week for the first 4 weeks, and every second week for the final 4 weeks. This can be adjusted to fit the participants needs. The VR is a novel technology, and this particular VR based training is not yet evaluated in research.
Endurance neck training group (10 participants)
10 participants will perform endurance training for the neck and shoulder region, with body weight, rubber bands, and free weights.
Endurance neck training
An 8-week traditional endurance neck training intervention. The training program consists of neck and shoulder exercises performed with body weight, rubber bands, and free weights. The training is carried out at home, 15-20 minutes per day, 5 days a week. The training is individualized and progressed during the intervention. Participants will have video consultations with their physiotherapist once a week for the first 4 weeks, and then every second week for the final 4 weeks. This can be adjusted to fit the participants needs. This intervention is often used in the clinic and has been evaluated in several research studies with good results to reduce neck pain. However, its effects on sensorimotor functions have been less evaluated. Also, its effects compared to novel VR-training still needs to be evaluated.
Interventions
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VR neck training
VR intervention 8 weeks. A VR headset is used for assessment and training of sensorimotor functions of the neck. The VR headset has a built-in sensor which can measure movements and give objective test and training results. The results serve as a guide for tailored home-based training programs, also performed with the VR headset in the experimental group. The participant performs the training at home, 15-20 minutes/day 5 days/week, initiallay divided into 3 sessions of 5 minutes each, while progression may lead to longer but fewer sessions. The program is individually tailored to target specific sensorimotor disturbances, and progressed during the intervention to increase the challenge. Participants will have video consultations with their physiotherapist once a week for the first 4 weeks, and every second week for the final 4 weeks. This can be adjusted to fit the participants needs. The VR is a novel technology, and this particular VR based training is not yet evaluated in research.
Endurance neck training
An 8-week traditional endurance neck training intervention. The training program consists of neck and shoulder exercises performed with body weight, rubber bands, and free weights. The training is carried out at home, 15-20 minutes per day, 5 days a week. The training is individualized and progressed during the intervention. Participants will have video consultations with their physiotherapist once a week for the first 4 weeks, and then every second week for the final 4 weeks. This can be adjusted to fit the participants needs. This intervention is often used in the clinic and has been evaluated in several research studies with good results to reduce neck pain. However, its effects on sensorimotor functions have been less evaluated. Also, its effects compared to novel VR-training still needs to be evaluated.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Luleå Tekniska Universitet
OTHER
Responsible Party
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Principal Investigators
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Ulrik Röijezon, Professor
Role: STUDY_CHAIR
Luleå University of Technology. Department of Health, Education and Technology
Central Contacts
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References
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GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.
Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control. Man Ther. 2008 Feb;13(1):2-11. doi: 10.1016/j.math.2007.06.003. Epub 2007 Aug 16.
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Sjolander P, Michaelson P, Jaric S, Djupsjobacka M. Sensorimotor disturbances in chronic neck pain--range of motion, peak velocity, smoothness of movement, and repositioning acuity. Man Ther. 2008 May;13(2):122-31. doi: 10.1016/j.math.2006.10.002. Epub 2007 Jan 2.
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de Vries J, Ischebeck BK, Voogt LP, van der Geest JN, Janssen M, Frens MA, Kleinrensink GJ. Joint position sense error in people with neck pain: A systematic review. Man Ther. 2015 Dec;20(6):736-44. doi: 10.1016/j.math.2015.04.015. Epub 2015 May 2.
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Other Identifiers
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EPM Dnr 2024-07490-01
Identifier Type: -
Identifier Source: org_study_id
CIV 24-08-048898
Identifier Type: OTHER
Identifier Source: secondary_id
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