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

Overview

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).

Interventions

• Other 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 prog
• Other 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 adjust

Primary outcome measures

• Feasibility - Recruitment time (weeks) [Time frame: From enrollment to end of treatment (at 8 weeks)]
• Feasibility - Recruitment method [Time frame: From enrollment to end of treatment (at 8 weeks)]
• Feasibility - Adherence [Time frame: Start of intervention to end of intervention at 8 weeks.]
• Feasibility - Completion rate (drop out) [Time frame: Start of intervention to end of intervention at 8 weeks.]
• Feasibility - Outcome measure completion rate [Time frame: At 8 weeks]
• Feasibility - Adverse events [Time frame: From start of intervention to 8 weeks]
• Feasibility - Numeric Rating Scale (NRS) Simulator sickness intensity [Time frame: Baseline and at end of intervention (at 8 weeks).]
• Feasibility - Participants experience using VR in neck training - Qualitative part [Time frame: After completion of the 8 weeks VR-intervention, approximately within 2 weeks after completion.]

Secondary outcome measures (12)

• Cervical joint position sense (JPS) test (performed in the VR headset) [Time frame: Baseline and at end of intervention (at 8 weeks)]
• Cervical reaction acuity (CRA) test - Reaction time milliseconds (performed in the VR headset) [Time frame: Baseline and at end of intervention (at 8 weeks)]
• Cervical reaction acuity (CRA) test - Maximum velocity. (performed in the VR headset) [Time frame: Baseline and at end of intervention (at 8 weeks)]
• Cervical reaction acuity (CRA) test - Time to complete the task. (performed in the VR headset) [Time frame: Baseline and at end of intervention (at 8 weeks)]
• Cervical movement sense test (performed in the VR headset) [Time frame: Baseline and at end of intervention (at 8 weeks)]
• Cervical range of motion test (performed in the VR headset) [Time frame: Baseline and at end of intervention (at 8 weeks)]
• Postural sway in quiet stance (performed with the VR headset) [Time frame: Baseline and at end of intervention (at 8 weeks)]
• Cervical flexion endurance test [Time frame: Baseline and at end of intervention (at 8 weeks)]
• Neck Disability Index (NDI) [Time frame: Baseline and at end of intervention (at 8 weeks)]
• Numeric Rating Scale (NRS) neck pain [Time frame: Baseline and at end of intervention (at 8 weeks)]
• Numeric Rating Scale (NRS) dizziness [Time frame: Baseline and at end of intervention (at 8 weeks)]
• Numeric Rating Scale (NRS) headache [Time frame: Baseline and at end of intervention (at 8 weeks)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 28919117
• 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. PMID 17702636
• Safiri S, Kolahi AA, Hoy D, Buchbinder R, Mansournia MA, Bettampadi D, Ashrafi-Asgarabad A, Almasi-Hashiani A, Smith E, Sepidarkish M, Cross M, Qorbani M, Moradi-Lakeh M, Woolf AD, March L, Collins G, Ferreira ML. Global, regional, and national burden of neck pain in the general population, 1990-2017: systematic analysis of the Global Burden of Disease Study 2017. BMJ. 2020 Mar 26;368:m791. doi: 1 PMID 32217608
• 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. PMID 17197230
• Sarig Bahat H, Croft K, Carter C, Hoddinott A, Sprecher E, Treleaven J. Remote kinematic training for patients with chronic neck pain: a randomised controlled trial. Eur Spine J. 2018 Jun;27(6):1309-1323. doi: 10.1007/s00586-017-5323-0. Epub 2017 Oct 10. PMID 29018956
• Sarig Bahat H, Chen X, Reznik D, Kodesh E, Treleaven J. Interactive cervical motion kinematics: sensitivity, specificity and clinically significant values for identifying kinematic impairments in patients with chronic neck pain. Man Ther. 2015 Apr;20(2):295-302. doi: 10.1016/j.math.2014.10.002. Epub 2014 Oct 14. PMID 25456272
• Roijezon U, Djupsjobacka M, Bjorklund M, Hager-Ross C, Grip H, Liebermann DG. Kinematics of fast cervical rotations in persons with chronic neck pain: a cross-sectional and reliability study. BMC Musculoskelet Disord. 2010 Sep 27;11:222. doi: 10.1186/1471-2474-11-222. PMID 20875135
• Roijezon U, Clark NC, Treleaven J. Proprioception in musculoskeletal rehabilitation. Part 1: Basic science and principles of assessment and clinical interventions. Man Ther. 2015 Jun;20(3):368-77. doi: 10.1016/j.math.2015.01.008. Epub 2015 Jan 29. PMID 25703454

Identifiers

NCT: NCT06832748 · EPM Dnr 2024-07490-01 · CIV 24-08-048898

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗