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

ConditionNeck Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLuleå Tekniska Universitet

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Cervical radiculopathy

Neck surgery

Fracture of the neck

Neurological disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • VR neck training

    Other intervention

    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

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: VR neck training group (10 participants)Experimental treatment 1 intervention
Group B: Endurance neck training group (10 participants)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility - Recruitment time (weeks)

Time taken to recruit 20 participants. This will be measured in number of weeks.

Time frame
From enrollment to end of treatment (at 8 weeks)
2

Feasibility - Recruitment method

Which recruitment channels were effective to find participants? (physiotherapy clinics, social media channels, newspaper advertisement, other). This will be measured by asking the participants.

Time frame
From enrollment to end of treatment (at 8 weeks)
3

Feasibility - Adherence

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

Time frame
Start of intervention to end of intervention at 8 weeks.
4

Feasibility - Completion rate (drop out)

Number of participants completing the intervention. Intervention completion rate feasibility criteria: ≥ 85% proceed, 70-85% proceed with changes, \<70% do not proceed.

Time frame
Start of intervention to end of intervention at 8 weeks.

Secondary outcomes

1

Cervical joint position sense (JPS) test (performed in the VR headset)

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.

Time frame
Baseline and at end of intervention (at 8 weeks)
2

Cervical reaction acuity (CRA) test - Reaction time milliseconds (performed in the VR headset)

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.

Time frame
Baseline and at end of intervention (at 8 weeks)
3

Cervical reaction acuity (CRA) test - Maximum velocity. (performed in the VR headset)

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.

Time frame
Baseline and at end of intervention (at 8 weeks)
4

Cervical reaction acuity (CRA) test - Time to complete the task. (performed in the VR headset)

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.

Time frame
Baseline and at end of intervention (at 8 weeks)

Other outcomes

Locations

This trial has no locations.

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